Clin Rheumatol DOI 10.1007/s10067-014-2845-2
REVIEW ARTICLE
Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence Mine Karagülle & Müfit Zeki Karagülle
Received: 29 September 2014 / Revised: 4 December 2014 / Accepted: 6 December 2014 # International League of Associations for Rheumatology (ILAR) 2014
Abstract In most European countries, balneotherapy and spa therapy are widely prescribed by physicians and preferred by European citizens for the treatment of musculoskeletal problems including chronic low back pain (LBP). We aimed to review and evaluate the recent evidence on the effectiveness of balneotherapy and spa therapy for patients with LBP. We comprehensively searched data bases for randomized controlled trials (RCTs) published in English between July 2005 and December 2013. We identified all trials testing balneotherapy or spa therapy for LBP that reported that the sequence of allocation was randomized. We finally included total of eight RCTs: two on balneotherapy and six on spa therapy. All reviewed trials reported that balneotherapy was superior in long term to tap water therapy in relieving pain and improving function and that spa therapy combining balneotherapy with mud pack therapy and/or exercise therapy, physiotherapy, and/or education was effective in the management of low back pain and superior or equally effective to the control treatments in short and long terms. We used Jadad scale to grade the methodological quality. Only three out of total eight had a score of above 3 indicating the good quality. The data from the RCTs indicates that overall evidence on effectiveness of balneotherapy and spa therapy in LBP is encouraging and reflects the consistency of previous evidence. However, the overall quality of trials is generally low. Better quality RCTs (well designed, conducted, and reported) are needed testing short- and long-term effects for relieving chronic back pain and proving broader beneficial effects.
M. Karagülle (*) : M. Z. Karagülle Department of Medical Ecology and Hydroclimatology, Istanbul Medical Faculty, Istanbul University, Millet cad 126, Capa, Istanbul 34093, Turkey e-mail: [email protected]
Keywords Low back pain < Rheumatic diseases . Balneotherapy . Randomized clinical trials < Methodology . Pain < Specialty fields . Spa therapy . Systematic reviews < Methodology
Introduction In central, eastern, southern, southeastern, and southwestern European countries, balneotherapy and spa therapy are widely used and preferred by European citizens who are seeking relief mostly from musculoskeletal problems including chronic low back pain [1, 2]. Balneotherapy is defined as the use of baths (in tubs or pools) containing thermal and/or mineral water from natural springs or drilled wells [3]. Immersion in thermal water with a natural temperature of at least 20 °C and/ or mineral water with a total mineral content of at least 1 g/L is the main mode of balneotherapy [3]. On the other hand, spa therapy besides balneotherapy additionally employs other balneological interventions such as mud applications, mineral water drinking, and inhalation at a spa therapy facility in spa resort [4, 5]. Some forms of hydrotherapeutic applications (showers, underwater pressure jets others with thermal mineral waters, and exercise in thermal water pools as well as other non-pharmacological therapies (massage, exercise etc.)) can also be combined within the spa therapy programs. These programs may vary substantially from one spa to another or one country to another. They mainly depend upon the experience and the tradition of a given spa resort and usually includes a period of 2 to 3 weeks of duration. Patients usually travel to a spa resort and stay there at a hotel or clinic during the entire spa therapy period (stationary spa therapy). In some countries, local patients from spa resort area visit daily the spa establishment (thermal spa cure center or thermal station or balneary station) for their spa therapy applications and then return to their daily routine (ambulatory spa therapy).
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Considering the devastating mental, physical, social, and economic burden that low back pain (LBP) causes to find out effective therapeutic measures is crucial [6]. Many European spa resorts offer balneotherapy and spa therapy programs for LBP. Despite the popularity of balneotherapy and spa therapy, it is often argued that they might prove an important nonpharmacological therapeutic tool in the management of chronic low back pain [7, 8]. A meta-analysis on effectiveness of balneotherapy and spa therapy for treating low back pain has been published a decade ago aiming to assess the existing evidence based on very few—only five in total—published clinical trials [9]. The analysis showed that even though the data were scarce, the evidence was encouraging suggesting that these modalities might be effective in pain reduction. The recent reviews evaluating the spa and balneotherapy in musculoskeletal problems also reported beneficial effects of spa and balneotherapy for musculoskeletal disorders including LBP [10–12]. In most European Union (EU) countries, spa therapy costs are at least partly reimbursed by health insurance systems since they have traditionally been considered as part of health services. This is going to be valid for entire EU very soon after the implementation of EU Directive 2011/24 for cross-border health care by individual countries in general [13]. Interestingly, neither among almost 40 different therapies that were scrutinized for developing European treatment guidelines for LBP nor among the recommended six therapies in European guidelines for the management of chronic low back pain spa and balneotherapy were not included [14]. Some 7 years later since the meta-analysis was published, we aimed to review and evaluate the current evidence and planned a comprehensive search of databases to identify the randomized controlled trials on the effectiveness of balneotherapy and spa therapy for patients with low back pain which were published during this period of time.
Methods We performed a systematic literature search to identify the recent randomized controlled trials examining and evaluating the effectiveness of balneotherapy (as a solitary approach) and spa therapy (as a therapy package including balneotherapy and other balneological and non-pharmacological modalities) on chronic low back pain. The following databases were searched: PubMed, Web of Science, Scopus and ClincalTrials.gov, USA. We used the search terms “balneotherapy,” “balneology,” “spa therapy,” “spa treatment,” “pain,” “low back pain,” and “RCT.” Each database was searched from July 2005 (to include all relevant studies published after the meta-analysis) until 31 December 2013. We restricted the language of publications to English aiming an international availability, acceptability, and understandability. We cross-checked the results we obtained from the
Potentially relevant articles (n=138)
Excluded Not relevant (n=114)
Retrieved for detailed evaluation (n=24)
Excluded (n=16) Not randomized (n=8) Not balneotherapy or spa therapy (n=5) Not clinical (n=3)
RCTs included for review (n=8) Balneotherapy (n=2) Spa therapy (n=6)
Fig. 1 Flowchart of trial selection process
searched databases and selected the most relevant publications for review. In final, we included the publications of randomized control trials reporting the effectiveness of spa and balneotherapy on LBP. We used Jadad checklist for methodological quality evaluation of the trials because of its simplicity and well-known reliability and external validity [15]. This system is developed to assess the quality of published clinical trials based on treatment methods relevant to random assignment, double blinding, and the flow of patients [16]. The range of possible scores is 0 (lowest) to 5 (best), and scores higher than 3 regarded as good quality. The quality was assessed independently by two authors, and when disagreements appeared, they were resolved through discussions by reaching a consensus at the end.
Results We finally identified a total of eight randomized controlled trial (RCTs) and included them for evaluation in this review (Fig. 1); two on balneotherapy [17, 18] (Table 1) and six on spa therapy [19–24] (Table 2). Only three trials were graded as good quality: one balneotherapy trial with a score of 3 [18] and two spa therapy trials with scores of 5 and 3 [21, 23] (Table 3). The rest of the trials had low Jadad scores; one spa therapy trial graded 0 [19], two (one balneotherapy and one spa therapy) 1 [17, 22], and two spa therapy trials each 2 [20, 24].
Beneficial effect on clinical parameters superior to tap water 3 Additional positive impact on the patients’ quality of life, as well as on their analgesic and NSAID requirements 60 patients living in the spa resort area, a daily routine, 10 weeks [18] Tefner et al. (2012)
Same in tap water
Outpatient 30 min, 36 °C in bath tubs (reclined) 12 sessions 2 weeks 6 days/week Outpatient 30 min, 31 °C in pool (free to move) 15 sessions 3 weeks 5 days/week 60 patients living in the spa resort area, daily routine, 3 months [17] Kehidakustány, Hungary Balogh 743 mg/L, sulfur (S2−); 2.4 mg/L, metasilicic acid; 37 mg/L et al. (2005)
Mátraderecske, Hungary 10,900 mg/L rich in sodium, magnesium, chloride, bicarbonate, sulfate, bromide; 9.4 mg/L
Balneotherapy Study population, follow-up
Same in tap water
Intergroup differences for pain and clinical improvement in 1 favor of balneotherapy, persisted 3 months
Balneotherapy RCTs for low back pain
Reference Spa resort, water total mineralization, and main (year) constituents
Table 1
Randomized controlled trials of balneotherapy for low back pain
Control Main results treatment
Jadad score
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Two RCTs tested the effectiveness of balneotherapy in LBP [17, 18]. Detailed information about the investigated balneotherapy or spa therapy regimens, thermal mineral water chemical composition used in balneotherapy, study populations, follow-up periods, control treatments, and main results of each of the eight RCTs are summarized in Tables 1 and 2. Balogh et al. in Kehidakustány, Hungary compared the effects of balneotherapy versus tap water baths on LBP in a single blind (the subjects) designed RCT [17]. Sixty patients with LBP living in the spa resort area assigned to balneotherapy and control group. Balneotherapy was delivered in the form of daily 30-min baths in tubs filled with warm (36 °C) water, 6 days per week (except Sundays), a total of 12 sessions on 15 consecutive days. The same procedure was applied to the control group patients with tap water as a kind of placebo or sham intervention. The color of the tap water was identical to that of the mineral water. Water used for balneotherapy was natural sulfur water with a 2.4 mg/L S2− concentration and oligomineral in character (743 mg/L total mineralization), containing relatively high amount of metasilicic acid, 37 mg/L. The patients’ condition was evaluated at baseline, at the end of the 2week therapy. Intergroup differences for pain and clinical improvement were found in favor of balneotherapy that persisted 3 months after the therapy. The quality score of this trial was low, 1. In a similar design, Tefner et al. in Mátraderecske, a small resort in Northern Hungary, tested balneotherapy for LBP [18]. Sixty patients living in the spa resort area were randomized to treatment and control groups. Patients continuing their daily routine underwent either 15 sessions of balneotherapy or tap water therapy five times a week for 3 weeks. The duration of the bath in pool (subjects were free to move) was 30 min; water temperature was 31 °C. The natural mineral water used in balneotherapy had high level of total mineralization of 10,900 mg/L and was rich in sodium, magnesium, chloride, bicarbonate, and sulfate with remarkable concentrations of bromide, 9.4 mg/L, and lithium, 6.9 mg/L. By the end of the balneotherapy course, VAS scores of low back pain at rest and on exertion, mobility of the lumbar spine (measured by lumbar Schober’s and lateral flexion in both directions), and disease-specific assessment (Oswestry questionnaire, EuroQoL-5D index, and SF-36 items) improved significantly in the balneotherapy group, compared to baseline. These improvements preserved up to 3 and 10 weeks. No significant changes recorded in the tap water group. Between-group differences in the above parameters both at the end of therapy period and at follow-ups showed superiority of balneotherapy. The quality was good with a score of 3.
[24] Gremeaux et al. (2013)
[23] Kesiktaş et al. (2012)
[22] Doğan et al. (2011)
[21] Kulisch et al. (2009)
[20] Demirel et al. (2008)
44 patients stayed in the spa resort No
[19] Leibetseder et al. (2007)
Spa therapy
Bad Tatzmannsdorf, Austria CO2 water, mineral mud
Inpatient 3 weeks 2–4 therapies/daily (not Sundays) mud packs, carbon dioxide baths, classic massages, under water massages, exercise therapy, spinal traction, electrotherapy+aerobic training Afyon, Turkey 54 patients living in the spa Outpatient Sodium, bicarbonate, resort area, after therapy 3 weeks sulfate, calcium, continued their daily 15 sessions magnesium, iron, routine 5 days/week aluminum, chlorine, No Balneotherapy 20–25 min, 36– metasilicate 38 °C+exercise supervised by a blinded physiotherapist Vulcan Spa, Celldömölk, 71 patients living in spa resort Outpatient Hungary area, after therapy 3 weeks 3350 mg/L rich in continued their daily 17–21 sessions, daily sodium, chloride, routine Balneotherapy 20 min, bicarbonate, fluoride; 15 weeks 34 °C+electrotherapy 6.5 mg/L Sıcak Çermik, Sivas, 60 patients hospitalized in Inpatient Turkey university spa clinic 3 weeks 15 sessions 3454 mg/L rich in No 5 days/week calcium, magnesium, Balneotherapy 20 min, bicarbonate, fluoride; ?°C+physiotherapy 2.2 mg/L, silicate 32 mg/L Karaali, Urfa, Turkey 60 patients living in the spa Outpatient Oligomineral, total resort area, 3 months 2 weeks mineral concentration; 10 sessions 580,73 mg/L, thermal 5 days/week water; temperature Balneotherapy 30 min, 36 °C+exercise 41.5 °C therapy+back education program. Amelie-les-Bains, France, 360 patients referred to spa Outpatient NA resort for spa therapy, after 3 weeks therapy continued their 15 sessions daily routine 6 months 5 days/week 20 min, 45 °C mud pack, mobilization in a mineral water pool at 33 °C, 15 min, and water spouts in the pool 10 min, hydrojet 10 min, + 3 education workshops
Study population, follow-up
Randomized controlled trials of spa therapy for low back pain
Reference (year) Spa resort, water total mineralization, and main constituents
Table 2
Jadad score
Decrease pain, disability, and depression and 2 increase spine mobility and quality of life, but only spa increased aerobic exercise capacity and respiratory muscles performance
After both of spa therapies positive effects in 0 both groups on all parameters (chronic pain and quality of life), no significant differences between the two groups (individualized aerobic training does not seem to enhance beneficial effects)
Main results
Outpatient Same spa therapy program+nonstandardize verbal information
Outpatient Physiotherapy, at the clinic of local state hospital physical therapy department
Inpatient Same physiotherapy program at physical therapy clinic in university hospital
1
Significant reduction in physical FABQ score 2 at 6 months, more marked in the intervention group significant decreased in disability and pain in both groups with no difference between groups
Improvement in back extensor muscle test, 3 Schober’s test, Oswestry Disability Index, some SF 36 scores, spa has advantageous in improving quality of life and flexibility
Significant improvement in all clinical parameters in both groups VAS, Schober, and Revised Oswestry Disability Index scores were better in spa group
Same spa therapy Significant improvement in all parameters 5 program with placebo thermal water group, still evident after (sham) tap water baths 15 weeks Comparison of the 2 groups thermal water spa therapy superior (pain and Schober)
Outpatient Exercise only, university physical therapy department
The same spa therapy program without aerobic training
Control treatment
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Clin Rheumatol Table 3
Randomized controlled trials of spa therapy and balneotherapy for low back pain: Jadad scores, journal names, and impact factors
(Reference), author, (year), treatment Journal
Jadad quality score
Journal impact factor
[17] Balogh et al. (2005) Balneotherapy [18] Tefner et al. (2012) Balneotherapy [19] Leibetseder et al. (2007) Spa therapy [20] Demirel et al. (2008) Spa therapy [21] Kulisch et al. (2009) Spa therapy
1
1,279
3 0
2,214 1,279
2 5
0,613 2,134
1 3 2
0,915 2,214 2,748
ForschendeKomplementärmedizin/Research in Complementary Medicine Rheumatology International ForschendeKomplementärmedizin/Research in Complementary Medicine Journal of Back and Musculoskeletal Rehabilitation Journal of Rehabilitation Medicine
[22] Doğan et al. (2011) Spa therapy Southern Medical Journal [23] Kesiktaş et al. (2012) Spa therapy Rheumatology International [24] Gremeaux et al. (2013) Spa Joint Bone Spine therapy
Spa therapy RCTs for low back pain Six RCTs tested the effectiveness of spa therapy in LBP [19–24]. Leibetseder et al. in Bad Tatzmannsdorf, Austria tested whether individualized aerobic training does enhance beneficial effects of a 3-week spa therapy on chronic pain and quality of life [19]. Forty-four patients were randomized into a group receiving spa therapy alone, and another group received the same spa therapy and carried out an additional aerobic training. Spa therapy consisted of 2–4 types of therapy applied daily including balneotherapy with CO2 water; mineral mud pack therapy; and classic massage, under water massage, exercise therapy, spinal traction and electrotherapy. Any information about the CO2 concentration and other mineral ingredients of the spa water was not given in the article, and this was true also for the mineral mud used in the treatments. After 3 weeks at the end of spa therapies, positive effects in both groups in chronic pain and quality of life were demonstrated and there were no significant differences between the two spa therapy groups. This study was graded with lowest score of 0. Demirel et al. in a trial scored low [2] randomly divided 54 patients living in Afyon about 10–15 km away from spa resort into two groups; treatment group had spa therapy (balneotherapy plus exercise) and control group followed only exercise therapy [20]. Spa therapy group underwent 15 sessions of ambulatory balneotherapy for 20–25 min at 36– 38 °C, five times a week and exercise sessions supervised by a physiotherapist at thermal clinic for 3 weeks. Control group followed exercise therapy at the outpatient physical therapy department. Each exercise program included Williams flexion exercise, spinal stabilization exercise, McKenzie extension exercise, abdominal strength exercise, and spinal stretching exercise. These exercises were applied 10 times for each session, and subjects took a rest for 2 min between each exercise. Balneotherapy was performed in thermal pool filled with natural thermal mineral water high in sodium,
bicarbonate, sulfate, calcium, magnesium, iron, aluminum, chlorine, and metasilicate. Both interventions significantly improved pain, disability, and depression and increased spine mobility and quality of life, but only spa therapy increased aerobic exercise capacity and respiratory muscles performance. But no comparison between the two therapy groups was reported and study did not include long-term assessments. The best quality trial with the best possible score of 5 was conducted at the Vulcan Spa, in Celldömölk, Hungary. Kulisch et al. in a double-blind, randomized controlled design allocated 71 LBP patients living near spa resort area into two groups [21]. The treatment group underwent 20-min balneotherapy at 34 °C daily for 3 weeks. The thermal water was rich in sodium, chloride, bicarbonate with a total mineralization of 3350 mg/L, and a fluoride concentration of 6.5 mg/L. Control group had therapy with tap water. Both treatment groups received adjunctive electrotherapy (diadynamic current) under standardized conditions. The study protocol required patients to attend at least 80 % of treatments, i.e., a minimum of 17 balneotherapy sessions. Significant improvements were seen in all parameters in balneotherapy plus electrotherapy group and this was still evident at 15-week follow-up. Comparing the two groups, spa treatment was found superior with improvements of perceived status as rated by patients and the patients’ progress by the investigator as well as the Schober’s index. Doğan et al. reported a trial with a low Jadad score of 1 comparing the effects of balneotherapy combined with physiotherapy and exercise therapy versus physiotherapy and exercise therapy combination in Sıcak Çermik, Sivas, Turkey [22]. Thirty-five patients in the first group were hospitalized in the balneology hospital and treated with spa therapy (balneotherapy, physiotherapy, and exercise therapy), and the second group (n=25) were hospitalized in the Physical Medicine and Rehabilitation Clinic and treated with physiotherapy and exercise therapy for 3 weeks. Inpatient spa therapy program consisted of 15 balneotherapy sessions (20 min,
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no information about the water temperature provided) and physiotherapy (ultrasound (US), transcutaneous electrical nerve stimulation (TENS) for and hot pack for 20 min each) and standard exercise sessions 5 days weekly. Same physiotherapy and exercises program were applied to the second group patients. Total mineral content of the spa water was 10,900 mg/L, rich in calcium, magnesium, bicarbonate, with a 2.2 mg/L fluoride, and 32 mg/L silicate levels. After therapy sessions, significant improvements in all clinical parameters in both groups were seen. Improvements in pain, Schober’s test, and Revised Oswestry Index (ROI) scores were significantly superior in spa therapy group than in control group. Study protocol did not include follow-up assessments. A good quality RCT scored 3 involved 60 patients with chronic degenerative low back pain [23]. Kesiktaş et al. gave physical therapy, transcutaneous electrical nerve stimulation (TENS), ultrasound, infrared radiation combined with back education program, and exercise to a group of patients at an outpatient clinic. Second group underwent spa therapy, 30min balneotherapy at 36 °C combined with the same back education, and exercise programs at a thermal center in Karaali thermal springs Urfa, Turkey. A local natural thermal (temperature 41.5 °C at origin) and oligomineral (total mineralization 580.73 mg/L) water was used. In both groups, during 2 weeks, a total of 10 sessions of either physiotherapy or spa therapy administered once daily five times weekly. Significant improvements in back extensor muscle test, lumbar flexibility (Schober’s test), functional capacity (Oswestry Disability Index), and quality of life (SF 36) and reduction in pain severity were found in both groups. These effects persisted even improved in spa therapy group 3 months later but this was not significantly different than physiotherapy group. Comparing the two groups at 3-month spa therapy had significant superiority to physical therapy in improving quality of life and flexibility of patients. Gremeaux et al. in a randomized prospective alternatemonth design-type study recruited 360 patients with LBP living the vicinity of the spa resort in Amelie-les-Bains, France and have been referred for spa therapy [24]. Intervention group underwent a spa therapy program for 3 weeks including 15 sessions of mud pack at 45 °C for 20 min, supervised mobilization in a mineral water pool at 33 °C, 15 min, and waterspouts in the pool 10 min, and hydrojet 10 min 5 days/week combined with three standardized education workshops every week lasting an hour and a half each. Information about the chemical composition of mineral water and mud was not given in the paper. Control group had identical spa therapy and non-standardized verbal information. They found a significant reduction in the physical fear avoidance beliefs (FABQ) score at 6 months in both study groups, and this reduction was more marked in the spa therapy group including education workshops. Disability (Quebec Scale) and pain also significantly decreased in both
groups, with no difference between groups. Jadad score of this study was 2.
Discussion Two RCTs tested effectiveness of two different balneotherapy methods [17, 18]. One was a passive immersion where patients relaxed in bath tubs [17], and the other was an active immersion where patients advised to be active during the bath in a pool with a 100-cm depth [18]. The bath water temperatures (36 and 31 °C, respectively) and as well as the waters used [low mineralized (total mineral 743 mg/L) sulfur water (2.4 mg/L S2−) and high mineralized (10,900 mg/L) bromide (9.4 mg/L) water, respectively] differed substantially. Furthermore, the tested balneotherapy methods regarding bath time and duration, frequency, and number of total sessions and duration of therapy and the frequency and total application sessions were slightly different, 2 weeks, 6 days/week, total 12 sessions [17] and 3 weeks, 5 days/week, total 15 sessions [18]. Interestingly, both balneotherapy regimens were found significantly superior in pain relief and clinical improvement in terms of spinal mobility and disability compared to tap water baths in follow-up at 3 months and 10 weeks. They also showed additional positive effects on patient quality of life and their analgesic and NSAID requirement. Six RCTs examined diverse spa therapy programs for LBP [19–24]. In these trials, spa therapy was applied as a combination of balneotherapy with mud pack therapy and/or exercise therapy [19] or supervised exercise therapy [20] or electrotherapy (diadynamic current) [21] or physiotherapy (ultrasound, TENS, and hot pack) and standard exercise therapy [22] or exercise therapy and back education program [23] or mud pack therapy, hydrotherapeutic applications, and back education program [24]. In general, they reported that the tested spa therapy programs combining balneotherapy, mud therapy, physiotherapy such as electrotherapy and other balneological interventions or education is effective in LBP in short and long terms and all spa therapy programs were superior or equally effective when compared to the control treatments. Among eight RCTs included for review, three trials were graded as good (3 and above): one balneotherapy trial [18] and one spa therapy trial [23] with score of 3 and one spa therapy trial [21] with highest score of 5. Most recent trials seem to be having higher quality probably reflecting the increased awareness and knowledge in methodology of RCTs evaluating balneotherapy and spa therapy, but there still exists a mismatch between these relatively intensified attempts in balneological interventions research and the paucity of the good quality trials with sufficient power and adequate data presentation. The overall volume of the evidence we found was small and originated from only eight RCTs assessing 649 patients
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with LBP. If we even add the earlier published five RCTs with a total population of 674 patients [25–29] which were analyzed in the meta-analysis on spa therapy and balneotherapy for LBP [9], we came up a total of 13 RCTs, four on balneotherapy and nine for spa therapy with a total study population of 1,323. This scarcity of the publications and low number of study subjects which in last 20 years gathered since when the first trial published in 1992 can be seen as the result of insufficient scientific research activity in balneology. This was in stark contrast to the popularity of these interventions among European patient populations. Interestingly, most trials included previous analysis and this review conducted in three countries: France [24, 26, 27, 29], Hungary [17, 18, 21, 25], and Turkey [20, 22, 23, 28], four studies from each. This may reflect the preference of the authors to publish in English with the hope that having a better chance for global citability of their local trials reporting effectiveness of balneotherapy and spa therapy in their own countries [30]. On the other hand, this might have caused publication and location bias which could not be verified [31, 32]. A systemic review including relevant trials published in different languages and conducted in different countries is needed but not feasible. We would like to note the inconsistency in terminology which was reflected in reporting of the trials. Even though in the title of one RCT the term spa therapy was preferred, we evaluated this study together with the balneotherapy trials, because in fact investigated intervention was balneotherapy [18]. More interestingly, three papers reporting the RCTs on spa therapy used the term balneotherapy in their titles to refer the modality they intended to test, but in reality, the treatment groups underwent spa therapy applied as a combination of balneotherapy with supervised exercise therapy [20] or physiotherapy (ultrasound, TENS, and hot pack) and standard exercise therapy [22] or exercise therapy and back education program [23]. Only in two RCTs, spa therapy was the right term both in the title and in the study protocol [19, 24]. New planned balneotherapy and spa therapy RCTs should have better reporting quality [33]. Very recently, a group of Japanese researchers developed a checklist of items by using the Delphi consensus method that describes and measures the quality of reports of trials that evaluate balneotherapy and spa therapy [34]. This checklist to assess the quality of reports on spa therapy and balneotherapy trials (The SPAC checklist) can be used when planning and reporting new trials to avoid the weakness of the study reporting together with the latest CONSORT 2010 Statement [35].
Conclusions The data from this review and from an earlier meta-analysis indicates the consistency of positive effects of balneotherapy and spa therapy for LBP. Across a range of outcome
measurements assessed in these publications, significant differential beneficial effects (most pronounced in reducing pain and improving function) in favor of spa therapy and balneotherapy have been shown in short and long terms. However, the quality of the RCTs evaluating balneotherapy and spa therapy for the treatment of low back pain is generally low. Better quality RCTs (well designed, conducted, and reported) are needed assessing short- and long-term effects of balneotherapy and spa therapy for relieving chronic back pain and moreover proving broadly beneficial effects in low back pain patients. Balneotherapy and spa therapy seem to be beneficial in patients with LBP and might be considered as a nonpharmacological therapeutic option for LBP where they are available especially for the local population living in the vicinity of a spa resort. But evidence on effectiveness of balneotherapy and spa therapy as therapy options in the treatment of LBP is yet insufficient and not conclusive.
Disclosures None.
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24. Gremeaux V, Benaïm C, Poiraudeau S, Hérisson C, Dupeyron A, Coudeyre E (2013) Evaluation of the benefits of low back pain patients’ education workshops during spa therapy. Joint Bone Spine 80:82–87 25. Konrad K, Tatrai T, Hunka A, Vereckei E, Korondi I (1992) Controlled trial of balneotherapy in treatment of low back pain. Ann Rheum Dis 51:820–822 26. Guillemin F, Constant F, Collin JF et al (1994) Short and long-term effect of spa therapy in chronic low back pain. Br J Rheumatol 33: 148–151 27. Constant F, Collin JF, Guillemin F, Boulangé M (1995) Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial. J Rheumatol 22:1315–1320 28. Yurtkuran M, Kahraman Z, Sivrioğlu K, Afşin Y, Doğan M (1997) Balneotherapy in low back pain. Eur J Phys Med Rehabil 7:120–123 29. Constant F, Guillemin F, Collin JF, Boulangé M (1998) Use of spa therapy to improve the quality of life of chronic low back pain patients. Med Care 36:1309–1314 30. Seglen PO (1994) Causal relationship between article citedness and journal impact. J Am Soc Information Sci 45:1–11 31. Dickersin K (1990) The existence of publication bias and risk factors for its occurrence. JAMA 263:1385–1389 32. Egger M, Davey SG (1998) Bias in location and selection of studies. BMJ 316:61–66 33. Altman DG, Schulz KF, Moher D et al (2001) The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann Intern Med 134:663–694 34. Kamioka H, Kawamura Y, Tsutani K, Maeda M, Hayasaka S, Okuizum H, Okada S, Honda T, Iijima Y (2013) A checklist to assess the quality of reports on spa therapy and balneotherapy trials was developed using the Delphi consensus method: the SPAC checklist. Complement Ther Med 21:324–332 35. Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 Statement: updated guidelines for reporting parallel group randomized trials. BMC Med 8:18
REVIEW ARTICLE
Effectiveness of balneotherapy and spa therapy for the treatment of chronic low back pain: a review on latest evidence Mine Karagülle & Müfit Zeki Karagülle
Received: 29 September 2014 / Revised: 4 December 2014 / Accepted: 6 December 2014 # International League of Associations for Rheumatology (ILAR) 2014
Abstract In most European countries, balneotherapy and spa therapy are widely prescribed by physicians and preferred by European citizens for the treatment of musculoskeletal problems including chronic low back pain (LBP). We aimed to review and evaluate the recent evidence on the effectiveness of balneotherapy and spa therapy for patients with LBP. We comprehensively searched data bases for randomized controlled trials (RCTs) published in English between July 2005 and December 2013. We identified all trials testing balneotherapy or spa therapy for LBP that reported that the sequence of allocation was randomized. We finally included total of eight RCTs: two on balneotherapy and six on spa therapy. All reviewed trials reported that balneotherapy was superior in long term to tap water therapy in relieving pain and improving function and that spa therapy combining balneotherapy with mud pack therapy and/or exercise therapy, physiotherapy, and/or education was effective in the management of low back pain and superior or equally effective to the control treatments in short and long terms. We used Jadad scale to grade the methodological quality. Only three out of total eight had a score of above 3 indicating the good quality. The data from the RCTs indicates that overall evidence on effectiveness of balneotherapy and spa therapy in LBP is encouraging and reflects the consistency of previous evidence. However, the overall quality of trials is generally low. Better quality RCTs (well designed, conducted, and reported) are needed testing short- and long-term effects for relieving chronic back pain and proving broader beneficial effects.
M. Karagülle (*) : M. Z. Karagülle Department of Medical Ecology and Hydroclimatology, Istanbul Medical Faculty, Istanbul University, Millet cad 126, Capa, Istanbul 34093, Turkey e-mail: [email protected]
Keywords Low back pain < Rheumatic diseases . Balneotherapy . Randomized clinical trials < Methodology . Pain < Specialty fields . Spa therapy . Systematic reviews < Methodology
Introduction In central, eastern, southern, southeastern, and southwestern European countries, balneotherapy and spa therapy are widely used and preferred by European citizens who are seeking relief mostly from musculoskeletal problems including chronic low back pain [1, 2]. Balneotherapy is defined as the use of baths (in tubs or pools) containing thermal and/or mineral water from natural springs or drilled wells [3]. Immersion in thermal water with a natural temperature of at least 20 °C and/ or mineral water with a total mineral content of at least 1 g/L is the main mode of balneotherapy [3]. On the other hand, spa therapy besides balneotherapy additionally employs other balneological interventions such as mud applications, mineral water drinking, and inhalation at a spa therapy facility in spa resort [4, 5]. Some forms of hydrotherapeutic applications (showers, underwater pressure jets others with thermal mineral waters, and exercise in thermal water pools as well as other non-pharmacological therapies (massage, exercise etc.)) can also be combined within the spa therapy programs. These programs may vary substantially from one spa to another or one country to another. They mainly depend upon the experience and the tradition of a given spa resort and usually includes a period of 2 to 3 weeks of duration. Patients usually travel to a spa resort and stay there at a hotel or clinic during the entire spa therapy period (stationary spa therapy). In some countries, local patients from spa resort area visit daily the spa establishment (thermal spa cure center or thermal station or balneary station) for their spa therapy applications and then return to their daily routine (ambulatory spa therapy).
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Considering the devastating mental, physical, social, and economic burden that low back pain (LBP) causes to find out effective therapeutic measures is crucial [6]. Many European spa resorts offer balneotherapy and spa therapy programs for LBP. Despite the popularity of balneotherapy and spa therapy, it is often argued that they might prove an important nonpharmacological therapeutic tool in the management of chronic low back pain [7, 8]. A meta-analysis on effectiveness of balneotherapy and spa therapy for treating low back pain has been published a decade ago aiming to assess the existing evidence based on very few—only five in total—published clinical trials [9]. The analysis showed that even though the data were scarce, the evidence was encouraging suggesting that these modalities might be effective in pain reduction. The recent reviews evaluating the spa and balneotherapy in musculoskeletal problems also reported beneficial effects of spa and balneotherapy for musculoskeletal disorders including LBP [10–12]. In most European Union (EU) countries, spa therapy costs are at least partly reimbursed by health insurance systems since they have traditionally been considered as part of health services. This is going to be valid for entire EU very soon after the implementation of EU Directive 2011/24 for cross-border health care by individual countries in general [13]. Interestingly, neither among almost 40 different therapies that were scrutinized for developing European treatment guidelines for LBP nor among the recommended six therapies in European guidelines for the management of chronic low back pain spa and balneotherapy were not included [14]. Some 7 years later since the meta-analysis was published, we aimed to review and evaluate the current evidence and planned a comprehensive search of databases to identify the randomized controlled trials on the effectiveness of balneotherapy and spa therapy for patients with low back pain which were published during this period of time.
Methods We performed a systematic literature search to identify the recent randomized controlled trials examining and evaluating the effectiveness of balneotherapy (as a solitary approach) and spa therapy (as a therapy package including balneotherapy and other balneological and non-pharmacological modalities) on chronic low back pain. The following databases were searched: PubMed, Web of Science, Scopus and ClincalTrials.gov, USA. We used the search terms “balneotherapy,” “balneology,” “spa therapy,” “spa treatment,” “pain,” “low back pain,” and “RCT.” Each database was searched from July 2005 (to include all relevant studies published after the meta-analysis) until 31 December 2013. We restricted the language of publications to English aiming an international availability, acceptability, and understandability. We cross-checked the results we obtained from the
Potentially relevant articles (n=138)
Excluded Not relevant (n=114)
Retrieved for detailed evaluation (n=24)
Excluded (n=16) Not randomized (n=8) Not balneotherapy or spa therapy (n=5) Not clinical (n=3)
RCTs included for review (n=8) Balneotherapy (n=2) Spa therapy (n=6)
Fig. 1 Flowchart of trial selection process
searched databases and selected the most relevant publications for review. In final, we included the publications of randomized control trials reporting the effectiveness of spa and balneotherapy on LBP. We used Jadad checklist for methodological quality evaluation of the trials because of its simplicity and well-known reliability and external validity [15]. This system is developed to assess the quality of published clinical trials based on treatment methods relevant to random assignment, double blinding, and the flow of patients [16]. The range of possible scores is 0 (lowest) to 5 (best), and scores higher than 3 regarded as good quality. The quality was assessed independently by two authors, and when disagreements appeared, they were resolved through discussions by reaching a consensus at the end.
Results We finally identified a total of eight randomized controlled trial (RCTs) and included them for evaluation in this review (Fig. 1); two on balneotherapy [17, 18] (Table 1) and six on spa therapy [19–24] (Table 2). Only three trials were graded as good quality: one balneotherapy trial with a score of 3 [18] and two spa therapy trials with scores of 5 and 3 [21, 23] (Table 3). The rest of the trials had low Jadad scores; one spa therapy trial graded 0 [19], two (one balneotherapy and one spa therapy) 1 [17, 22], and two spa therapy trials each 2 [20, 24].
Beneficial effect on clinical parameters superior to tap water 3 Additional positive impact on the patients’ quality of life, as well as on their analgesic and NSAID requirements 60 patients living in the spa resort area, a daily routine, 10 weeks [18] Tefner et al. (2012)
Same in tap water
Outpatient 30 min, 36 °C in bath tubs (reclined) 12 sessions 2 weeks 6 days/week Outpatient 30 min, 31 °C in pool (free to move) 15 sessions 3 weeks 5 days/week 60 patients living in the spa resort area, daily routine, 3 months [17] Kehidakustány, Hungary Balogh 743 mg/L, sulfur (S2−); 2.4 mg/L, metasilicic acid; 37 mg/L et al. (2005)
Mátraderecske, Hungary 10,900 mg/L rich in sodium, magnesium, chloride, bicarbonate, sulfate, bromide; 9.4 mg/L
Balneotherapy Study population, follow-up
Same in tap water
Intergroup differences for pain and clinical improvement in 1 favor of balneotherapy, persisted 3 months
Balneotherapy RCTs for low back pain
Reference Spa resort, water total mineralization, and main (year) constituents
Table 1
Randomized controlled trials of balneotherapy for low back pain
Control Main results treatment
Jadad score
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Two RCTs tested the effectiveness of balneotherapy in LBP [17, 18]. Detailed information about the investigated balneotherapy or spa therapy regimens, thermal mineral water chemical composition used in balneotherapy, study populations, follow-up periods, control treatments, and main results of each of the eight RCTs are summarized in Tables 1 and 2. Balogh et al. in Kehidakustány, Hungary compared the effects of balneotherapy versus tap water baths on LBP in a single blind (the subjects) designed RCT [17]. Sixty patients with LBP living in the spa resort area assigned to balneotherapy and control group. Balneotherapy was delivered in the form of daily 30-min baths in tubs filled with warm (36 °C) water, 6 days per week (except Sundays), a total of 12 sessions on 15 consecutive days. The same procedure was applied to the control group patients with tap water as a kind of placebo or sham intervention. The color of the tap water was identical to that of the mineral water. Water used for balneotherapy was natural sulfur water with a 2.4 mg/L S2− concentration and oligomineral in character (743 mg/L total mineralization), containing relatively high amount of metasilicic acid, 37 mg/L. The patients’ condition was evaluated at baseline, at the end of the 2week therapy. Intergroup differences for pain and clinical improvement were found in favor of balneotherapy that persisted 3 months after the therapy. The quality score of this trial was low, 1. In a similar design, Tefner et al. in Mátraderecske, a small resort in Northern Hungary, tested balneotherapy for LBP [18]. Sixty patients living in the spa resort area were randomized to treatment and control groups. Patients continuing their daily routine underwent either 15 sessions of balneotherapy or tap water therapy five times a week for 3 weeks. The duration of the bath in pool (subjects were free to move) was 30 min; water temperature was 31 °C. The natural mineral water used in balneotherapy had high level of total mineralization of 10,900 mg/L and was rich in sodium, magnesium, chloride, bicarbonate, and sulfate with remarkable concentrations of bromide, 9.4 mg/L, and lithium, 6.9 mg/L. By the end of the balneotherapy course, VAS scores of low back pain at rest and on exertion, mobility of the lumbar spine (measured by lumbar Schober’s and lateral flexion in both directions), and disease-specific assessment (Oswestry questionnaire, EuroQoL-5D index, and SF-36 items) improved significantly in the balneotherapy group, compared to baseline. These improvements preserved up to 3 and 10 weeks. No significant changes recorded in the tap water group. Between-group differences in the above parameters both at the end of therapy period and at follow-ups showed superiority of balneotherapy. The quality was good with a score of 3.
[24] Gremeaux et al. (2013)
[23] Kesiktaş et al. (2012)
[22] Doğan et al. (2011)
[21] Kulisch et al. (2009)
[20] Demirel et al. (2008)
44 patients stayed in the spa resort No
[19] Leibetseder et al. (2007)
Spa therapy
Bad Tatzmannsdorf, Austria CO2 water, mineral mud
Inpatient 3 weeks 2–4 therapies/daily (not Sundays) mud packs, carbon dioxide baths, classic massages, under water massages, exercise therapy, spinal traction, electrotherapy+aerobic training Afyon, Turkey 54 patients living in the spa Outpatient Sodium, bicarbonate, resort area, after therapy 3 weeks sulfate, calcium, continued their daily 15 sessions magnesium, iron, routine 5 days/week aluminum, chlorine, No Balneotherapy 20–25 min, 36– metasilicate 38 °C+exercise supervised by a blinded physiotherapist Vulcan Spa, Celldömölk, 71 patients living in spa resort Outpatient Hungary area, after therapy 3 weeks 3350 mg/L rich in continued their daily 17–21 sessions, daily sodium, chloride, routine Balneotherapy 20 min, bicarbonate, fluoride; 15 weeks 34 °C+electrotherapy 6.5 mg/L Sıcak Çermik, Sivas, 60 patients hospitalized in Inpatient Turkey university spa clinic 3 weeks 15 sessions 3454 mg/L rich in No 5 days/week calcium, magnesium, Balneotherapy 20 min, bicarbonate, fluoride; ?°C+physiotherapy 2.2 mg/L, silicate 32 mg/L Karaali, Urfa, Turkey 60 patients living in the spa Outpatient Oligomineral, total resort area, 3 months 2 weeks mineral concentration; 10 sessions 580,73 mg/L, thermal 5 days/week water; temperature Balneotherapy 30 min, 36 °C+exercise 41.5 °C therapy+back education program. Amelie-les-Bains, France, 360 patients referred to spa Outpatient NA resort for spa therapy, after 3 weeks therapy continued their 15 sessions daily routine 6 months 5 days/week 20 min, 45 °C mud pack, mobilization in a mineral water pool at 33 °C, 15 min, and water spouts in the pool 10 min, hydrojet 10 min, + 3 education workshops
Study population, follow-up
Randomized controlled trials of spa therapy for low back pain
Reference (year) Spa resort, water total mineralization, and main constituents
Table 2
Jadad score
Decrease pain, disability, and depression and 2 increase spine mobility and quality of life, but only spa increased aerobic exercise capacity and respiratory muscles performance
After both of spa therapies positive effects in 0 both groups on all parameters (chronic pain and quality of life), no significant differences between the two groups (individualized aerobic training does not seem to enhance beneficial effects)
Main results
Outpatient Same spa therapy program+nonstandardize verbal information
Outpatient Physiotherapy, at the clinic of local state hospital physical therapy department
Inpatient Same physiotherapy program at physical therapy clinic in university hospital
1
Significant reduction in physical FABQ score 2 at 6 months, more marked in the intervention group significant decreased in disability and pain in both groups with no difference between groups
Improvement in back extensor muscle test, 3 Schober’s test, Oswestry Disability Index, some SF 36 scores, spa has advantageous in improving quality of life and flexibility
Significant improvement in all clinical parameters in both groups VAS, Schober, and Revised Oswestry Disability Index scores were better in spa group
Same spa therapy Significant improvement in all parameters 5 program with placebo thermal water group, still evident after (sham) tap water baths 15 weeks Comparison of the 2 groups thermal water spa therapy superior (pain and Schober)
Outpatient Exercise only, university physical therapy department
The same spa therapy program without aerobic training
Control treatment
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Randomized controlled trials of spa therapy and balneotherapy for low back pain: Jadad scores, journal names, and impact factors
(Reference), author, (year), treatment Journal
Jadad quality score
Journal impact factor
[17] Balogh et al. (2005) Balneotherapy [18] Tefner et al. (2012) Balneotherapy [19] Leibetseder et al. (2007) Spa therapy [20] Demirel et al. (2008) Spa therapy [21] Kulisch et al. (2009) Spa therapy
1
1,279
3 0
2,214 1,279
2 5
0,613 2,134
1 3 2
0,915 2,214 2,748
ForschendeKomplementärmedizin/Research in Complementary Medicine Rheumatology International ForschendeKomplementärmedizin/Research in Complementary Medicine Journal of Back and Musculoskeletal Rehabilitation Journal of Rehabilitation Medicine
[22] Doğan et al. (2011) Spa therapy Southern Medical Journal [23] Kesiktaş et al. (2012) Spa therapy Rheumatology International [24] Gremeaux et al. (2013) Spa Joint Bone Spine therapy
Spa therapy RCTs for low back pain Six RCTs tested the effectiveness of spa therapy in LBP [19–24]. Leibetseder et al. in Bad Tatzmannsdorf, Austria tested whether individualized aerobic training does enhance beneficial effects of a 3-week spa therapy on chronic pain and quality of life [19]. Forty-four patients were randomized into a group receiving spa therapy alone, and another group received the same spa therapy and carried out an additional aerobic training. Spa therapy consisted of 2–4 types of therapy applied daily including balneotherapy with CO2 water; mineral mud pack therapy; and classic massage, under water massage, exercise therapy, spinal traction and electrotherapy. Any information about the CO2 concentration and other mineral ingredients of the spa water was not given in the article, and this was true also for the mineral mud used in the treatments. After 3 weeks at the end of spa therapies, positive effects in both groups in chronic pain and quality of life were demonstrated and there were no significant differences between the two spa therapy groups. This study was graded with lowest score of 0. Demirel et al. in a trial scored low [2] randomly divided 54 patients living in Afyon about 10–15 km away from spa resort into two groups; treatment group had spa therapy (balneotherapy plus exercise) and control group followed only exercise therapy [20]. Spa therapy group underwent 15 sessions of ambulatory balneotherapy for 20–25 min at 36– 38 °C, five times a week and exercise sessions supervised by a physiotherapist at thermal clinic for 3 weeks. Control group followed exercise therapy at the outpatient physical therapy department. Each exercise program included Williams flexion exercise, spinal stabilization exercise, McKenzie extension exercise, abdominal strength exercise, and spinal stretching exercise. These exercises were applied 10 times for each session, and subjects took a rest for 2 min between each exercise. Balneotherapy was performed in thermal pool filled with natural thermal mineral water high in sodium,
bicarbonate, sulfate, calcium, magnesium, iron, aluminum, chlorine, and metasilicate. Both interventions significantly improved pain, disability, and depression and increased spine mobility and quality of life, but only spa therapy increased aerobic exercise capacity and respiratory muscles performance. But no comparison between the two therapy groups was reported and study did not include long-term assessments. The best quality trial with the best possible score of 5 was conducted at the Vulcan Spa, in Celldömölk, Hungary. Kulisch et al. in a double-blind, randomized controlled design allocated 71 LBP patients living near spa resort area into two groups [21]. The treatment group underwent 20-min balneotherapy at 34 °C daily for 3 weeks. The thermal water was rich in sodium, chloride, bicarbonate with a total mineralization of 3350 mg/L, and a fluoride concentration of 6.5 mg/L. Control group had therapy with tap water. Both treatment groups received adjunctive electrotherapy (diadynamic current) under standardized conditions. The study protocol required patients to attend at least 80 % of treatments, i.e., a minimum of 17 balneotherapy sessions. Significant improvements were seen in all parameters in balneotherapy plus electrotherapy group and this was still evident at 15-week follow-up. Comparing the two groups, spa treatment was found superior with improvements of perceived status as rated by patients and the patients’ progress by the investigator as well as the Schober’s index. Doğan et al. reported a trial with a low Jadad score of 1 comparing the effects of balneotherapy combined with physiotherapy and exercise therapy versus physiotherapy and exercise therapy combination in Sıcak Çermik, Sivas, Turkey [22]. Thirty-five patients in the first group were hospitalized in the balneology hospital and treated with spa therapy (balneotherapy, physiotherapy, and exercise therapy), and the second group (n=25) were hospitalized in the Physical Medicine and Rehabilitation Clinic and treated with physiotherapy and exercise therapy for 3 weeks. Inpatient spa therapy program consisted of 15 balneotherapy sessions (20 min,
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no information about the water temperature provided) and physiotherapy (ultrasound (US), transcutaneous electrical nerve stimulation (TENS) for and hot pack for 20 min each) and standard exercise sessions 5 days weekly. Same physiotherapy and exercises program were applied to the second group patients. Total mineral content of the spa water was 10,900 mg/L, rich in calcium, magnesium, bicarbonate, with a 2.2 mg/L fluoride, and 32 mg/L silicate levels. After therapy sessions, significant improvements in all clinical parameters in both groups were seen. Improvements in pain, Schober’s test, and Revised Oswestry Index (ROI) scores were significantly superior in spa therapy group than in control group. Study protocol did not include follow-up assessments. A good quality RCT scored 3 involved 60 patients with chronic degenerative low back pain [23]. Kesiktaş et al. gave physical therapy, transcutaneous electrical nerve stimulation (TENS), ultrasound, infrared radiation combined with back education program, and exercise to a group of patients at an outpatient clinic. Second group underwent spa therapy, 30min balneotherapy at 36 °C combined with the same back education, and exercise programs at a thermal center in Karaali thermal springs Urfa, Turkey. A local natural thermal (temperature 41.5 °C at origin) and oligomineral (total mineralization 580.73 mg/L) water was used. In both groups, during 2 weeks, a total of 10 sessions of either physiotherapy or spa therapy administered once daily five times weekly. Significant improvements in back extensor muscle test, lumbar flexibility (Schober’s test), functional capacity (Oswestry Disability Index), and quality of life (SF 36) and reduction in pain severity were found in both groups. These effects persisted even improved in spa therapy group 3 months later but this was not significantly different than physiotherapy group. Comparing the two groups at 3-month spa therapy had significant superiority to physical therapy in improving quality of life and flexibility of patients. Gremeaux et al. in a randomized prospective alternatemonth design-type study recruited 360 patients with LBP living the vicinity of the spa resort in Amelie-les-Bains, France and have been referred for spa therapy [24]. Intervention group underwent a spa therapy program for 3 weeks including 15 sessions of mud pack at 45 °C for 20 min, supervised mobilization in a mineral water pool at 33 °C, 15 min, and waterspouts in the pool 10 min, and hydrojet 10 min 5 days/week combined with three standardized education workshops every week lasting an hour and a half each. Information about the chemical composition of mineral water and mud was not given in the paper. Control group had identical spa therapy and non-standardized verbal information. They found a significant reduction in the physical fear avoidance beliefs (FABQ) score at 6 months in both study groups, and this reduction was more marked in the spa therapy group including education workshops. Disability (Quebec Scale) and pain also significantly decreased in both
groups, with no difference between groups. Jadad score of this study was 2.
Discussion Two RCTs tested effectiveness of two different balneotherapy methods [17, 18]. One was a passive immersion where patients relaxed in bath tubs [17], and the other was an active immersion where patients advised to be active during the bath in a pool with a 100-cm depth [18]. The bath water temperatures (36 and 31 °C, respectively) and as well as the waters used [low mineralized (total mineral 743 mg/L) sulfur water (2.4 mg/L S2−) and high mineralized (10,900 mg/L) bromide (9.4 mg/L) water, respectively] differed substantially. Furthermore, the tested balneotherapy methods regarding bath time and duration, frequency, and number of total sessions and duration of therapy and the frequency and total application sessions were slightly different, 2 weeks, 6 days/week, total 12 sessions [17] and 3 weeks, 5 days/week, total 15 sessions [18]. Interestingly, both balneotherapy regimens were found significantly superior in pain relief and clinical improvement in terms of spinal mobility and disability compared to tap water baths in follow-up at 3 months and 10 weeks. They also showed additional positive effects on patient quality of life and their analgesic and NSAID requirement. Six RCTs examined diverse spa therapy programs for LBP [19–24]. In these trials, spa therapy was applied as a combination of balneotherapy with mud pack therapy and/or exercise therapy [19] or supervised exercise therapy [20] or electrotherapy (diadynamic current) [21] or physiotherapy (ultrasound, TENS, and hot pack) and standard exercise therapy [22] or exercise therapy and back education program [23] or mud pack therapy, hydrotherapeutic applications, and back education program [24]. In general, they reported that the tested spa therapy programs combining balneotherapy, mud therapy, physiotherapy such as electrotherapy and other balneological interventions or education is effective in LBP in short and long terms and all spa therapy programs were superior or equally effective when compared to the control treatments. Among eight RCTs included for review, three trials were graded as good (3 and above): one balneotherapy trial [18] and one spa therapy trial [23] with score of 3 and one spa therapy trial [21] with highest score of 5. Most recent trials seem to be having higher quality probably reflecting the increased awareness and knowledge in methodology of RCTs evaluating balneotherapy and spa therapy, but there still exists a mismatch between these relatively intensified attempts in balneological interventions research and the paucity of the good quality trials with sufficient power and adequate data presentation. The overall volume of the evidence we found was small and originated from only eight RCTs assessing 649 patients
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with LBP. If we even add the earlier published five RCTs with a total population of 674 patients [25–29] which were analyzed in the meta-analysis on spa therapy and balneotherapy for LBP [9], we came up a total of 13 RCTs, four on balneotherapy and nine for spa therapy with a total study population of 1,323. This scarcity of the publications and low number of study subjects which in last 20 years gathered since when the first trial published in 1992 can be seen as the result of insufficient scientific research activity in balneology. This was in stark contrast to the popularity of these interventions among European patient populations. Interestingly, most trials included previous analysis and this review conducted in three countries: France [24, 26, 27, 29], Hungary [17, 18, 21, 25], and Turkey [20, 22, 23, 28], four studies from each. This may reflect the preference of the authors to publish in English with the hope that having a better chance for global citability of their local trials reporting effectiveness of balneotherapy and spa therapy in their own countries [30]. On the other hand, this might have caused publication and location bias which could not be verified [31, 32]. A systemic review including relevant trials published in different languages and conducted in different countries is needed but not feasible. We would like to note the inconsistency in terminology which was reflected in reporting of the trials. Even though in the title of one RCT the term spa therapy was preferred, we evaluated this study together with the balneotherapy trials, because in fact investigated intervention was balneotherapy [18]. More interestingly, three papers reporting the RCTs on spa therapy used the term balneotherapy in their titles to refer the modality they intended to test, but in reality, the treatment groups underwent spa therapy applied as a combination of balneotherapy with supervised exercise therapy [20] or physiotherapy (ultrasound, TENS, and hot pack) and standard exercise therapy [22] or exercise therapy and back education program [23]. Only in two RCTs, spa therapy was the right term both in the title and in the study protocol [19, 24]. New planned balneotherapy and spa therapy RCTs should have better reporting quality [33]. Very recently, a group of Japanese researchers developed a checklist of items by using the Delphi consensus method that describes and measures the quality of reports of trials that evaluate balneotherapy and spa therapy [34]. This checklist to assess the quality of reports on spa therapy and balneotherapy trials (The SPAC checklist) can be used when planning and reporting new trials to avoid the weakness of the study reporting together with the latest CONSORT 2010 Statement [35].
Conclusions The data from this review and from an earlier meta-analysis indicates the consistency of positive effects of balneotherapy and spa therapy for LBP. Across a range of outcome
measurements assessed in these publications, significant differential beneficial effects (most pronounced in reducing pain and improving function) in favor of spa therapy and balneotherapy have been shown in short and long terms. However, the quality of the RCTs evaluating balneotherapy and spa therapy for the treatment of low back pain is generally low. Better quality RCTs (well designed, conducted, and reported) are needed assessing short- and long-term effects of balneotherapy and spa therapy for relieving chronic back pain and moreover proving broadly beneficial effects in low back pain patients. Balneotherapy and spa therapy seem to be beneficial in patients with LBP and might be considered as a nonpharmacological therapeutic option for LBP where they are available especially for the local population living in the vicinity of a spa resort. But evidence on effectiveness of balneotherapy and spa therapy as therapy options in the treatment of LBP is yet insufficient and not conclusive.
Disclosures None.
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