ORIGINAL ARTICLE

Interdisciplinary Treatment of Patients with Fibromyalgia: Improvement of Their HealthRelated Quality of Life Josune Mart
ın, PhD*; Fernando Torre, MD†; Angel Padierna, MD‡,§; na Matellanes, PhD¶; Urko Aguirre, MSc*,§; Nerea Gonz
alez, PhD*,§; Bego~ Jos
e M. Quintana, PhD*,§ *Research Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia; †Pain Management Unit, Galdakao-Usansolo Hospital, Galdakao, Bizkaia; ‡Department of Psychiatry, Galdakao-Usansolo Hospital, Galdakao, Bizkaia; §Health Services Research on Chronic Patients Network (REDISSEC), Galdakao, Bizkaia; ¶Department of Psychology, Universidad Deusto, Bilbao, Bizkaia, Spain

& Abstract Objective: To assess whether an interdisciplinary intervention is more effective than usual care for improving the health-related quality of life (HRQoL) among patients with fibromyalgia (FM), and to identify variables that were predictors of improvement in HRQoL. Methods: In a randomized controlled clinical trial carried out on an outpatient basis in a hospital pain management unit, 153 patients with FM were randomly allocated to an experimental group (EG) or a control group (CG). Participants completed the Fibromyalgia Impact Questionnaire (FIQ) at baseline and 6 months after the intervention. The EG received an interdisciplinary treatment (12 sessions for 6 weeks) which consisted of coordinated psychological, medical, educational, and physiotherapeutic interventions while the CG received standard-of-care pharmacologic treatment. Descriptive statistics, ANOVA, Chi square and Fisher

Address correspondence and reprint requests to: Josune Mart
ın, PhD,
n, 9ª planta. Hospital Galdakao—Usansolo, Barrio Unidad de Investigacio Labeaga, s/n, Galdakao 48960, Bizkaia, Spain. E-mail: josune.martincorral @osakidetza.net. Submitted: April 17, 2013; Revision accepted: September 16, 2013 DOI. 10.1111/papr.12134

© 2013 World Institute of Pain, 1530-7085/13/$15.00 Pain Practice, Volume 14, Issue 8, 2014 721–731

tests and generalized linear models were used for data analysis. Results: Six months after the intervention, statistically significant improvements in HRQoL were observed in physical functioning (P = 0.01), pain (P = 0.03) and total FIQ score (P = 0.04) in the EG compared to the CG. The number of physical illnesses was identified as a predictor for improvement. Conclusions: This interdisciplinary intervention has shown effectiveness in improving the HRQoL of this sample of patients with FM. The number of physical illnesses was identified as a predictor of that improvement. & Key Words: fibromyalgia, FIQ, interdisciplinary treatment, quality of life, RCT, randomized controlled trial

INTRODUCTION Fibromyalgia (FM) is characterized by widespread pain, hypersensitivity to palpation at specific body locations (tender points),1 and a range of comorbid physical and mental symptoms, and functional limitations, including persistent fatigue, or poor sleep.2–4 The prevalence in general adult populations is estimated at between 0.7% and 3.3%.5 In Spain, the prevalence of FM is 2% to 3%; it affects mainly women, with new diagnoses peaking

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between the ages of 40 and 49 years.6 This is in keeping with estimates of 2.9% in 5 European countries,7 and 2% in the United States.8 In certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units9 or 12% of patients referred to rheumatology specialists in Spain.10 In our hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit. Fibromyalgia is a persistent and debilitating disorder that can have a devastating effect on people’s lives, affecting their ability to work and engage in everyday activities, as well as their relationships.11,12 FM produces various degrees of disability and pain.13 It also has a clear impact on health-related quality of life (HRQoL). Burckhardt et al.,14 observed lower HRQoL among patients with FM than among healthy subjects. Indeed, the HRQoL for those with FM was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease.15 Among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with FM had the worst outcome 6 months after diagnosis as measured by HRQoL.16 The characteristics of FM, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. FM patients often feel frustrated and dissatisfied with the treatment they receive.17 As a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of FM presents a challenge for clinicians.18 Clinical research suggests that pharmacologic treatment alone is not the best approach for FM,19 and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.20–30 A recent meta-analysis2 concluded that there is strong evidence of the efficacy of multicomponent therapy to reduce some key symptoms of FM at post-treatment. Despite these promising results, pharmacological treatment remains the option offered to Spanish FM patients to manage their condition. Unfortunately, up to 50% of patients with FM do not improve significantly with standard pharmacologic treatment.31 When patients with FM arrive at the pain management unit of a hospital, they have travelled through several services, and the effectiveness of the treatments prescribed was usually minimal. The main aim of this study was to assess whether an interdisciplinary

intervention implemented by a multidisciplinary team situated in a pain management unit at a hospital, and based on PSYchological, Medical, Educational, and PHYsiotherapeutic components (PSYMEPHY), improves the HRQoL of patients with FM to a greater extent than the usual care following 6 months of interdisciplinary treatment. In addition, predictors for improvement in HRQoL were identified.

METHODS The study was approved by the Research and Ethics Committee of the Hospital Galdakao-Usansolo.

SUBJECTS A randomized controlled clinical trial was conducted from 2007 to 2009 (clinicaltrials.gov registration number: NCT01266733). This manuscript is part of a study whose questionnaires and outcomes are available at clinicaltrials.gov. The study population was drawn from patients referred to the pain management unit of the Hospital Galdakao-Usansolo, a 400-bed teaching hospital in the Basque Country (northern Spain) that serves a population of 300,000 inhabitants. It belongs to the network of public hospitals of the Basque Health Care Service, which provides free unrestricted care to nearly 100% of the population. To be eligible for the study, a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology,1 which include chronic widespread pain and tenderness upon on palpation in at least 11 of 18 specified tender point sites.1 Other eligibility criteria included being 18 years or older and having had continuous chronic pain for at least 6 months. Patients were excluded if they declined to participate in the study, were suffering from a severe depression, psychosis, delusional disorder, or were involved in employment-related legal proceedings related to their FM. All participants in the trial provided written consent. Study Design and Intervention Fibromyalgia patients attending the pain management unit were contacted by telephone. An investigator explained the purpose, objectives and methodology of the study, and invited them to participate. One hundredeighty agreed to participate voluntarily in the research (92.8% response rate). Once the sample was determined,

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a list of random numbers was developed by the statistician, so that patients could be separated and randomly assigned to a control group (CG, n = 90) or and experimental group (EG, n = 90). Patients in the CG received what is currently the standard pharmacologic care for FM in Spain. This included pharmacological treatment with a tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/24 hours), an analgesic (paracetamol, maximum dose of 4 g/24 hours), and an opioid central analgesic (tramadol, maximum dose of 400 mg/24 hours). Patients in the EG received the same pharmacological treatment. They also participated in 6 weeks of PSYMEPHY delivered by a team that included a physician, a clinical psychologist, and a physiotherapist experienced in chronic pain management. Each team member had extensive experience in treating chronic pain in patients with and without FM. Patients in the PSYMEPHY group were divided into groups of 12 individuals. The same treatment team managed all of the groups. Interdisciplinary treatment consisted of 12 sessions in 6 weeks (2 session per week), that is, in each 6-week series: each of the 6 sessions consisted of 1 hour with the psychologist and 45 minutes of educational activities with the physician and psychologist and each of the other 6 sessions consisted of 1 hour with the psychologist and 45 minutes with the physiotherapist. The treatment program followed a protocol written by 3 members of our team under the supervision of the pain management unit and the rheumatology and psychiatry services of Hospital Galdakao-Usansolo, based on the cognitive-behavioral treatment developed by Philips.32 Attendance was recorded for each patient at each session. The psychological component of PSYMEPHY was focused around cognitive behavioral therapy (CBT) interventions developed in line with the recommendations of Bennett and Nelson.33 The CBT component, administered by a PhD-qualified psychologist, targeted 3 domains: cognitive, physiological, and behavioral. At the cognitive level, the intervention was designed to help patients identify and challenge overly negative pain-related thoughts and to replace these thoughts with more adaptive coping thoughts. At the physiological level, patients were trained to perform diaphragmatic breathing and progressive muscle relaxation. At the behavioral level, patients were trained in communication skills to enhance appropriate assertiveness and strengthen interactions with healthcare providers and others. They were also trained in appropriate behavioral

pacing of activities in order to avoid excessively high or low levels of activity. The group sessions had the following structure: (1) a brief summary of the topics covered in the previous session and discussion of activities carried out at home, (2) introduction of the topic for the current session, (3) practical exercises and other activities on the topic of the day, as well as practicing breathing and relaxation exercises, and (4) an explanation of the tasks to be carried out at home during the following week. The educational component of the intervention addressed topics related to the characteristics of FM such as the nature of the condition, its usual course, treatment possibilities, appropriate organization of daily activities (including the gradual increase of intensity and planning of breaks), and the physician-patient relationship. Also explored were the mechanisms and the psychology of pain (gate control concept, learning processes, and psychosocial influences) in order to give patients a basis for understanding and applying selfcontrol techniques. In addition, patients were given the opportunity to discuss the impact of FM on their lives and to ask questions to their peers and staff. The physiotherapeutic component was based on the research of Jones et al.,34 and for this component, patients performed a progressive physical training, with warming, stretching and muscle strengthening exercises (non-aerobic) performed in the standing, sitting, and lying positions, without machine weights. The intervention provided balance, body posture, and alternative exercises for transient low back, knee, and shoulder pain common in FM. The physical therapy session focused on the benefits of exercise and provided the rationale for a regular exercise program. Exercise and stretching routines were demonstrated and practiced during the session. Training focused on activity modification principles, such as working at a moderate pace, frequent position changes, and resting before fatigue sets in. After the 6-month follow-up assessment, patients in the CG were offered the PSYMEPHY treatment. Instruments and Data Collection Sociodemographic data were collected by a physician of the pain management unit. The self-administered questionnaire was collected by a researcher not involved in providing treatment. The following sociodemographic variables were collected: age, sex, marital status, level of education, and employment status. Patients’ clinical histories were also recorded, including any diagnosed

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physical illnesses, number of years since the onset of pain, if there was a precipitating event of FM, and number of tender points.1 To assess the self-control coping strategy (cognitive efforts to try to decrease pain), we used the Coping with Chronic Pain Questionnaire (CAD-R).35 The Fibromyalgia Impact Questionnaire (FIQ)36–38 was used to assess the impact of FM on HRQoL. This validated instrument uses visual scales to measure how much FM affects functional capacity (10 items refer to activities of daily living), the ability to work (considering both paid and un-paid work, such as housework), and subjective items related to FM (amount of pain and whether a patient felt rested, tiredness, stiffness, anxiety, or depression). Each item has a maximum score of 10; the maximum score on the questionnaire is 100. The higher the score, the greater the impact of FM on HRQoL. FIQ scores between 50 and 69 indicate average to high impact of FM, while scores ≥ 70 indicate a severe impact.39 This questionnaire is considered to have a good reliability and validity, justifying its use in clinical practice and research.40,41 A version of the FIQ has been translated into, and validated in Spanish.38 All patients completed the FIQ at baseline and again 6 months after completing the PSYMEPHY treatment. Statistical Analysis Based on the literature,42 we estimated a priori that a sample size of 57 in each group could have 80% power to detect a mean difference of 5,000 units in the change of total FIQ score (ie, the difference between the Group 1 mean, l1, of 10,000 and a Group 2 mean, l2, of 5,000) assuming a common standard deviation of 9,500 using a 2 group t-test with a 0.050 2-sided significance level. Mean and standard deviation were calculated for continuous variables; qualitative variables were expressed in terms of frequency and percentage. To evaluate the relationship of patients’ main characteristics with the 2 study groups (EG and CG), Student’s ttest or Chi-Square test were used, if the variable was continuous or categorical, respectively. The same tests were applied to compare sociodemographic and clinical characteristics between patients who followed the study and those who did not. Student t-tests were used to compare means in the FIQ questionnaire between EG and CG. This was done for scores measured at baseline and at follow-up. For the assessment of change of the FIQ scores, a repeated ANOVA analysis was performed by means of linear mixed models: baseline and 6 months

after the PSYMEPHY treatment as outcome was considered and treatment group was the independent variable. Unstructured variance-covariance matrix was used. To estimate the magnitude of important changes in the analyzed measures, Cohen’s effect size (ES) with their confidence intervals at 95% was calculated, defining as the division of the mean difference of changes in both comparative groups and the pooled standard deviation of the change43; a positive ES favors the EG. A cut-off > 0.5 indicated moderate change. To identify variables that were predictors of change for the total FIQ score after 6 months, linear mixed models were performed. Total FIQ score measured at baseline and 6 months after the treatment were the outcomes. Sociodemographic and clinical variables were the independent variables. An univariate analysis was performed initially and variables with P < 0.20 were included in the multivariable analysis. This was done for each study group, separately. Statistical analyses were performed with the SAS statistical package (V9.1). In all cases, comparisons were pairwise and the results were considered to be statistically significant when P < 0.05.

RESULTS A total of 194 patients with FM were referred to our pain management clinic during the trial period. Of these, 180 (92.8%) agreed to participate in the trial. At baseline, 71 patients in the EG and 82 in the CG completed the FIQ, while 56 of the EG and 54 in the CG completed the survey 6 months after the intervention (Figure 1). The sociodemographic variables and clinical histories of FM patients included in the study are described in Table 1. The time since the onset of pain was ranged from 1 to 40 years. No statistically significant differences were observed in any of these variables between the EG and the CG at baseline (Table 1). In addition, no significant differences were observed among baseline variables between patients who did not complete the FIQ at 6 months (n = 43) and those who did (n = 110), and nor were differences between patients who completed the FIQ at baseline and 6 months later (CG = 56, EG = 54). The baseline variables used for this analysis were the same variables included in Table 1. At baseline, FM had similar effects on HRQoL, as measured by the FIQ, in the experimental and CGs, ie, both groups had similar scores on the FIQ questionnaire. Six months after the intervention, a statistically

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PATIENTS WITH FIBROMYALGIA CONTACTED n = 194

AGREED TO PARTICIPATE n = 180

RANDOMLY ASSIGNED TO CG n = 90

DECUNED TO PARTICIPATE n = 14

RANDOMLY ASSIGNED TO EG n = 90 NON RESPONDENTS at baseline from CG n = 19

RESPONDENTS at baseline from CG n = 71

NON RESPONDENTS at baseline from EG n=8 RESPONDENTS at baseline from EG n = 82 12 dropouts: 5 patients did not attend any session and 7 patients only attended the first session INTERDISCIPLINARY TREATMENT (6 weeks) PSYMEPHY n =70

RESPONDENTS at 6 months from CG n = 56

NON RESPONDENTS at 6 months from CG n = 15

RESPONDENTS at 6 months from EG n = 54

NON RESPONDENTS at 6 months from EG n = 16 not attend follow-up session at 6 months, but did attend all sessions of treatment

Figure 1. CONSORT diagram: Study patients with fibromyalgia. CG, control group; EG, experimental group.

significant improvement in HRQoL was observed in the EG in physical functioning (P = 0.01), pain (P = 0.03), and total FIQ score (P = 0.04) compared to the CG. Patients who received the interdisciplinary PSYMEPHY treatment experienced less pain and had higher functional capacity than patients who did not receive that treatment. Scores in other areas of the FIQ also decreased in the EG, reflecting improvements in HRQoL, but the differences were not statistically significant (Table 2). The ESs of change in the EG were higher than 0.20 in the FIQ areas of physical functioning, missed work, pain, felling rested on waking, stiffness, anxiety, and total score. The results for univariate analysis of the change in the total FIQ score at 6 months for the CG and EG, according to their sociodemographic variables at baseline time, have not been included in tables, because all of them were not statistically significant. In the univariate analysis, sex, age, employment status, tender points, time since the onset of the pain, and number of physical illnesses were not statistically significant predictors of improvement, although the P value for number of illnesses was 0.05. In the multivariate analysis (Table 3),

total FIQ score at baseline and the number of physical illnesses were significant predictors of a reduction in the total FIQ score, so that those patients in the EG who had 2 or more physical illnesses compared to those without any pathology experienced an improvement in the impact of FM on HRQoL.

DISCUSSION An interdisciplinary treatment that included coordinated psychological, medical, educational, and physiotherapeutic interventions (PSYMEPHY) improved HRQoL, physical functioning, and pain level among FM patients compared to pharmacologic therapy alone. It was found that this interdisciplinary treatment in a group setting in a hospital environment was effective in improvement the HRQoL, physical function, and pain in patients with FM as compared with the usual treatment in these patients, 6 months after the treatment. This is the first trial to assess the efficacy of an interdisciplinary treatment for patients with FM in patients drawn from a hospital pain management unit in the Basque Country. Our results are consistent with

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Table 1. Baseline Data on Patients with Fibromyalgia (FM) Who Completed the Fibromyalgia Impact Questionnaire 6 Months after the Intervention, by Group (Control or Experimental) Total Patients (n = 110) n (%) Age (years) x (SD) Sex Female Male Marital status Single Married Separated or divorced Widow/Widower Level of Education Primary education Secondary education College or above Employment status Active Non-paid work Disabled Retired Additional physical illnesses Hypothyroidism High blood pressure COPD Diabetes mellitus Rheumatoid arthritis Other Number of additional physical illnesses None One Two or more (2 to 4) Years since the onset of pain x (SD) Precipitating event in FM§ Presence of 18 tender points¶ Self-control (CAD-R) x (SD)

Control Group (n = 56) n (%)

Experimental Group (n = 54) n (%)

†

50.15 (9.26)*

48.68 (8.68)

51.57 (9.65)

‡

P value 0.07

100 (90.91) 10 (9.09)

51 (91.07) 5 (8.93)

49 (90.74) 5 (9.26)

0.95

5 (4.55) 94 (85.45) 8 (7.27) 3 (2.73)

3 (5.36) 45 (80.36) 5 (8.93) 3 (5.36)

2 (3.70) 49 (90.74) 3 (5.56) 0 (0.00)

0.28

62 (56.36) 37 (33.64) 11 (10.00)

37 (66.07) 14 (25.00) 5 (8.93)

25 (46.30) 23 (42.59) 6 (11.11)

59 22 16 13

25 13 11 7

(44.64) (23.21) (19.64) (12.50)

34 (62.96) 9 (16.67) 5 (9.26) 6 (11.11)

0.22

13 (11.82) 11 (10.00) 13 (11.82) 3 (2.73) 3 (2.73) 46 (41.82)

4 (7.14) 8 (14.29) 6 (10.71) 1 (1.79) 2 (3.57) 20 (35.71)

9 (16.67) 3 (5.56) 7 (12.96) 2 (3.70) 1 (1.85) 26 (48.15)

0.12 0.13 0.71 0.54 0.58 0.19

38 (34.55) 45 (40.91) 27 (24.55) 14.13 (10.01) 45 (43.27) 46 (45.54) 6.14 (4.29)

20 (35.71) 20 (35.71) 16 (28.57) 13.5 (10.09) 23 (43.40) 21 (40.38) 6.52 (4.20)

18 (33.33) 25 (46.30) 11 (20.37) 14.78 (9.97) 22 (43.14) 25 (51.02) 5.79 (4.38)

0.46

(53.64) (20.00) (14.55) (11.82)

0.41 0.98 0.28 0.30

x, mean; SD, standard deviation; COPD, Chronic Obstructive Pulmonary Disease; CAD-R: Coping with Chronic Pain Questionnaire. *Overall range of age of patients = 29 to 70. † Range of age of patients in the control group = 29 to 69. ‡ Range of age of patients of the experimental group = 31 to 70. § The onset of FM is associated with certain precipitating event like physical or emotional traumas, infections, or surgeries. ¶ Eighteen tender points is the maximum number of tender points according to the ACR diagnostic criteria of FM. The Chi square or Fisher’s exact test were used for comparing qualitative variables, while the Student’s t test for independent samples was used for quantitative variables. Level of significance P < 0.05.

Table 2. Comparison Between Experimental and CG Scores on the FIQ at Baseline and at 6 Months Baseline (Prior to Interdisciplinary Treatment)

FIQ Physical impairment Feel good Work missed Do work Pain Fatigue Rested Stiffness Anxiety Depression Total score

6 Months after Interdisciplinary Treatment

Change*

CG (n = 56)

EG (n = 54)

CG (n = 56)

EG (n = 54)

CG (n = 56)

EG (n = 54)

x (SD)

x (SD)

P value

x (SD)

x (SD)

P value

x (SE)

x (SE)

P value

ES (95% IC)

5.40 (1.76)

5.47 (1.87)

0.84

5.92 (1.84)

5.19 (1.83)

0.04

0.52 (0.22)

0.27 (0.22)

0.01

0.50 (0.11, 0.87)

8.76 (1.92) 5.74 (4.72) 7.48 (2.62) 7.51 (1.97) 8.74 (1.46) 8.58 (1.76) 8.08 (2.25) 7.72 (2.24) 6.90 (3.06) 76.28 (13.57)

0.93 0.80 0.63 0.95 0.99 0.42 0.66 0.66 0.59 0.98

8.35 (2.11) 7.27 (4.56) 7.69 (1.96) 8.22 (1.62) 8.78 (1.69) 8.43 (1.82) 7.94 (2.33) 7.13 (2.83) 6.61 (3.14) 76.81 (14.18)

8.14 (2.29) 5.48 (4.70) 7.14 (2.22) 7.24 (2.17) 8.50 (1.81) 7.81 (2.20) 7.42 (2.45) 6.31 (2.93) 6.44 (3.13) 70.33 (16.48)

0.62 0.17 0.19 0.01 0.41 0.12 0.26 0.14 0.78 0.02

0.43 (0.35) 1.13 (1.25) 0.04 (0.38) 0.70 (0.30) 0.04 (0.29) 0.16 (0.32) 0.06 (0.38) 0.37 (0.38) 0.56 (0.39) 0.58 (1.95)

0.61 (0.34) 0.32 (1.12) 0.32 (0.38) 0.27 (0.31) 0.23 (0.30) 0.82 (0.33) 0.67 (0.38) 1.40 (0.39) 0.49 (0.40) 5.95 (1.98)

0.72 0.39 0.51 0.03 0.51 0.04 0.18 0.06 0.90 0.02

0.05 ( 0.33, 0.45) 0.24 ( 0.37, 0.88) 0.19 ( 0.23, 0.61) 0.45 (0.05, 0.83) 0.11 ( 0.27, 0.49) 0.50 (0.11, 0.87) 0.27 ( 0.11, 0.65) 0.38 ( 0.010, 0.76) 0.006 ( 0.39, 0.37) 0.45 (0.07, 0.83)

8.79 6.10 7.70 7.53 8.74 8.27 7.89 7.52 7.20 76.23

(1.65) (4.74) (1.94) (2.19) (1.37) (2.16) (2.26) (2.45) (2.83) (14.88)

x, mean; SD, standard deviation; CG, control group; EG, experimental group; FIQ, Fibromyalgia Impact Questionnaire, a higher score representing a greater impact; 95% CI, confidence interval at 95%. Maximum possible FIQ score: 100; 50 to 69 = average to high impact; ≥ 70 = severe impact. Change: difference between baseline and 6 months after the treatment between experimental and control group. *Repeated measures ANCOVA models (linear mixed models) were used. ES: effect size (0.20 = small effect; 0.50 = medium effect); positive ES favors the EG; negative ES favors the CG. P values in bold indicated a significance level of P < 0.05.

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Table 3. Multivariate Analysis of the Change in the Impact of Fibromyalgia on Health-Related Quality of Life as Measured by the Fibromyalgia Impact Questionnaire 6 Months after the Intervention in the Control and the Experimental Groups Change in Total FIQ Score Experimental Group b (SE) Time effect Baseline (Ref) 6 months after the treatment Number of physical illnesses* 0 (Ref) 1 ≥2 Tender points* 18 (Ref) < 18 Self-control (CAD-R)*

Control Group

P value

b (SE)

P value

— 12.96 (3.61)

0.001

— 1.21 (3.11)

0.70

— 0.88 (4.77) 15.10 (5.89)

0.86 0.01

— 7.45 (4.11) 11.08 (4.42)

0.08 0.02

— 8.28 (4.16) 0.87 (0.46)

0.05 0.07

— 8.50 (4.26) 0.07 (0.42)

0.05 0.86

FIQ, fibromyalgia impact on quality of life; CAD-R, Coping with Chronic Pain Questionnaire; Ref, reference group; b, beta; SE, standard error; “—”, not applicable. Linear mixed models were used. *Coefficients obtained of the interaction between Time effect and the covariate, indicating the effect of the covariate over the mean FIQ change. P values in bold indicated a significance level of: P < 0.05.

previous studies2,20,44,45 that concluded that multicomponent therapy is effective for decreasing pain and FM impact at the end of treatment. In the pain domain, the results of this randomized trial echo those of other studies of interdisciplinary treatment for FM. For example, Lemstra and Olszynski24 tested an intervention similar to ours that consisted of participation in a 6-week outpatient program of cognitive-behavioral therapy and physical activity. Patients receiving this intervention reported a reduction in pain intensity compared to patients in the CG who received standard treatment. In contrast, other multidisciplinary interventions among FM patients demonstrated little or no improvement in pain. Neither Burckhardt et al.,14 who carried out a 6-week program with 2 EGs—one education based and the other combining education with physical activity—nor Vlaeyen et al.,46 who conducted an intervention consisting of educational and cognitive-educational treatment groups, reported any improvement in pain in the EGs compared to the CGs. Likewise, Gelman et al.,47 in a sample of 21 patients with FM, reported no improvement in the intensity of pain after 15 weeks of multidisciplinary treatment that included cognitive-behavioral therapy, physical activity, and rheumatologic care. The divergent findings in the pain domain may be due in part to

differences in study designs, measurement instruments, and treatments applied. In our trial, patients with FM who received the PSYMEPHY interdisciplinary treatment maintained statistically significant improvements at 6 months in parameters describing FM’s impact on HRQoL compared to patients who did not receive this treatment. Concerning the changes of quality of life at 6 months, the interdisciplinary treatment reduced the impact of FM on patient HRQoL. This is in line with findings of other studies of multimodal treatments in which HRQoL was also assessed using the FIQ.31,48–51 Furthermore, the ES of the impact of FM on HRQoL in our intervention group compared to the CG was 0.45, slightly larger than the value of 0.32 reported by Mannerkorpi et al.51 Patients in the EG reported generally improved physical function 6 months after the intervention, which included being more active and perceiving less pain in the week prior to completing the final FIQ. These outcomes are in line with improvements in HRQoL, measured by the FIQ, observed in other studies of multimodal treatments.45,48–52 Of note, several authors have proposed that these types of improvements should be the objective of treatment for patients with FM.32,53 In the absence of standard multidisciplinary or interdisciplinary treatments for FM, or standard study designs, it is difficult to compare our study with others.54 Some prior studies did not include a CG.55 Kroese et al.,56 for example, carried out a multidisciplinary intervention consisting of 12 weeks of daily sessions of education, physiotherapy, psychotherapy and creative art therapy. At the end of the program, the 100 patients reported that their FM had less negative impact on their HRQoL. Worrel et al.57 achieved a similar improvement using a much shorter (1.5 day) interdisciplinary program, while Luedtke et al.25 assessed another short multidisciplinary program based on education and occupational therapy, using a large sample of 2,631 individuals with FM. As in our study, all these studies used the FIQ. The key difference is that our study also included a CG against which to compare the outcomes. In other studies, the effects of interdisciplinary therapy were not sustained to 6 months.58 Some authors did not describe the type of interdisciplinary components used in their intervention.59 In our trial, the number of comorbid conditions and the baseline FIQ score were significant predictors of improvement in patients who received interdisciplinary treatment. The presence of 2 or more other physical

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illnesses was the variable that best predicted a reduction in the impact of FM on HRQoL 6 months after the intervention. It is possible that FM patients who acquired coping skills during the PSYMEPHY treatment applied them in their daily lives, and thus were better able to cope with their other conditions, which would have been reflected in an improvement in HRQoL. Patients most severely affected by FM, as reflected in higher FIQ scores at the beginning of the study, showed better rates of improvement than those with lower baseline FIQ scores. This is in line with findings of Worrel et al.57 in their 1.5 day-long treatment program for patients with FM. In that study, the only variable significantly associated with an improvement in FM was “being more severely affected at baseline.” It is possible that greater improvement among the patients most severely affected by FM (those with higher total FIQ scores) may indicate regression towards the mean, especially since Worrel et al. identified no other predictors. Strengths of our study included a careful methodology and a proper design through a clinical trial, a reasonable sample size, and inclusion of a CG. Our assessment at 6 months produced highly satisfactory results, both in terms of statistical significance and magnitude of change. Another strength was the high variability (31.75%) in the improvement of the impact of FM in our EG explained by the clinical variables. In contrast, King et al.50 reported relatively smaller values (between 4% and 15%). Finally, it was ethically important to have offered the PSYMEPHY intervention to patients in the CG after the 6 month follow-up of the intervention. The effects of the interdisciplinary treatment in the CG patients who were later offered the PSYMEPHY intervention will be the subject of future analysis. Limitations of the study included the selection of the trial population and the duration of the intervention. Because all participants were selected from patients referred to a hospital pain management unit, it is possible that they experienced a greater impact of FM on HRQoL than patients treated in primary care. This could limit the generalization of our findings, and it would be important to investigate whether the interdisciplinary treatment is as successful in a wider context, such as in primary care centers. Another limitation is that sample sizes of 54/56 per group are likely to be too small to yield all meaningful predictors. The calculations were done on the basis of 57 people per group. However, there were respectively 56 and 54 per group

at 6 months. So the statistical precision and power may have been closer to 60%. It should be noted that there was a considerable attrition and consequently, analyzing only patients who have the follow-up measurements could lead to bias results and a loss of power. Additional, differential drop-out would need to be tested; even if not significant, it is meaningfully different between groups. Another limitation is that the improvement was modest. The observed effect might have been due to the caring of professionals or their continued presence rather than the intervention content of the PSYMEPHY treatment. A substitute “false” treatment could have helped in controlling for this factor. Yet another limitation of our study was the lack of any objective physical measure. For future research, it would be interesting to combine these measures with those reporting patient reported outcomes (PROMs); assessment of tender point should be completed both pre and post-treatment in order to assess changes in this variable. Further, characteristic of this patient population, females were over-represented in this sample and hence the extent to which these findings can be generalized to men with FM is unclear. The instruments were not repeated at the conclusion of treatment. Six weeks (as post-treatment measure) might not have been long enough to internalize the contents of the interventions and implement the skills learned. Finally, since in the interdisciplinary perspective the patient is treated in a coordinated manner by the different professionals, it is difficult to know which component brings more improvement to the patient. A key limitation is that our control condition is rather weak; for future research, it could be better to use a comparison group receiving 2 hours of education about FM. In addition, the interdisciplinary PSYMEPHY intervention was provided for only 6 weeks. It would be important to assess the effectiveness of this treatment over a longer term, such as a year or more, given the importance of maintenance of results. The mean duration of pain in our patients was high (14.13 years), and this may account for the relatively small treatment effects 6 months after the intervention. Such interventions may be more successful earlier in the course of illness, at the beginning of the symptoms.45 For future research it would be suggested to use the FIQ-Revised60 as it may be more sensitive to change that the original version and reports about physical data would be useful. It would also be important to use the more recent ACR criteria for FM.61 Finally, future studies of follow-up assessments should determine the direct and indirect costs

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derived from the intervention, a question of crucial importance for policymakers. In conclusion, interdisciplinary treatment specifically developed for patients with FM that included coordinated PSYMEPHY improved physical functioning, pain level, and HRQoL. Such interdisciplinary interventions may be appropriate for patients referred to hospital pain management units and yield better outcomes than standard pharmacotherapy alone.

KEY POINTS 



The interdisciplinary treatment improved physical functioning, pain level, and HRQoL in patients with FM. Total FIQ score and the number of physical illnesses at baseline were significant predictors of a reduction in the total FIQ score.

ACKNOWLEDGEMENTS This study has been carried out with funding from Department of Health of the Basque Country (project nº 2006111057), “Improvement of the health-related quality of life of patients suffering from FM using multidisciplinary treatment” granted to Fernando Torre, the principal investigator. The authors acknowledge editorial assistance provided by Patrick Skerrett. We also would like to thank all the individuals with FM who participated in our study. All the authors declare no conflict of interests.

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