Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial.

http://informahealthcare.com/dre ISSN 0963-8288 print/ISSN 1464-5165 online Disabil Rehabil, Early Online: 1–10 ! 2015 Informa UK Ltd. DOI: 10.3109/09638288.2015.1044036

RESEARCH PAPER

Basic body awareness therapy or exercise therapy for the treatment of chronic whiplash associated disorders: a randomized comparative clinical trial

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Aris Seferiadis1,2,3, Pernilla Ohlin2, Annika Billhult2, and Ronny Gunnarsson2,3,4 1

Department of Occupational and Physical Therapy, Sahlgrenska University Hospital, Gothenburg, Sweden, 2Research and Development Unit, Primary Health Care and Dental Care, Southern A¨lvsborg County, Region Va¨stra Go¨taland, Sweden, 3Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, Go¨teborg University, Gothenburg, Sweden, and 4Cairns Clinical School, School of Medicine and Dentistry, James Cook University, Townsville, QLD, Australia Abstract

Keywords

Purpose: Chronic whiplash-associated disorders (WAD) incur both costs and suffering. Treatments that can relieve chronic WAD are therefore needed. Exercise therapy (ET) has been shown to provide pain relief. Another often used treatment for chronic pain in Scandinavia is basic body awareness therapy (BAT). We compared the effectiveness of 10 weeks of twice-weekly, 90-min sessions of either ET or BAT in a randomized comparative trial. Method: We recruited 113 patients suffering from chronic WAD grades I–III and several years’ duration of symptoms in a primary health care setting. 57 were allocated to ET and 56 to BAT. Primary outcome measures were Neck Disability Index and SF-36 v.2. Results: From baseline to posttreatment, the BAT group increased their physical functioning (median 5, IQR ¼ 15) more than the ET group (median ¼ 0, IQR ¼ 15), p ¼ 0.032, effect size 0.54. Three months after the end of treatment, the BAT group had less bodily pain (m ¼ 17.5, 95% CI 6.9–17.6) than the ET group (m ¼ 4.9, 95% CI 0.1 to 9.8), p ¼ 0.044, effect size 0.4. The BAT group had also increased their social functioning (m ¼ 13.3, 95% CI 6.6–19.9) more than the ET group (m ¼ 3.5, 95% CI 3 to 9.9), p ¼ 0.037, effect size 0.41. No statistically significant differences between groups were found for the change of other outcomes. No serious adverse effects were found in either groups. Conclusions: The present trial indicates that BAT led to greater improvements than ET for the patients with chronic WAD.

Body awareness therapy, exercise, Neck Disability Index, SF-36, whiplash History Received 29 October 2014 Revised 12 April 2015 Accepted 20 April 2015 Published online 8 May 2015

ä Implications for Rehabilation

Chronic whiplash-associated disorders are disabling and incur great costs to society often through inability to work. Exercise therapy (ET) may alleviate symptoms of chronic WAD. Basic body awareness therapy (BAT) is often a component of multimodal pain rehabilitation programs. In this randomized comparative trial, BAT increased physical functioning and led to greater pain reduction and social functioning 3 months after the end of treatment.

Introduction Background and objectives Whiplash-associated disorders (WAD) are the symptoms incurred after indirect trauma to the neck by acceleration-deceleration forces [1]. WAD is characterized by neck and/or shoulder pain with or without radicular symptoms, headache and loss of cervical mobility. The incidence of traffic-related WAD has increased in Address for correspondence: Aris Seferiadis, Department of Occupational and Physical Therapy, Sahlgrenska University Hospital, Tunnlandsgatan 2A Byggnad 9, Ho¨gsbo Hospital, Gothenburg, SE 421 38, Sweden. E-mail: [email protected]

some western countries during the past 30 years [2] but has remained stable in Sweden during the period 2000–2009 at 235 per 100 000 inhabitants per year [3]. As many as 50% of those affected by WAD may report neck pain symptoms 1 year later [4] and if symptoms remain unresolved within 6 months, the condition is defined as chronic and has a poor prognosis [5]. Inevitably, WAD incurs great cost to society even in a small country such as Sweden where 4 billion SEK (EUR 413 000 000; USD 552 000 000) yearly are attributed to WAD [6]. According to the international initiative of the Bone and Joint Decade 2000–2010 Task Force on Neck Pain and its Associated Disorders (BJD), WAD probably results from cervical sprain or strain, but the exact pathophysiology is unknown [7], and there is


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A. Seferiadis et al.

no diagnostic gold standard to detect WAD [8]. As a consequence, there is very little evidence to guide clinicians to the correct treatment for patients already suffering from chronic WAD. The BJD reviewed studies of treatment for chronic WAD and suggested that clinicians might consider supervised exercises or coordinated multidisciplinary care but could not identify any specific effective intervention [9]. Exercise therapy (ET) has long been used by physiotherapists to improve muscle function and alleviate pain. Supervised ET in chronic WAD can improve self-efficacy beliefs, reduce disability and fear of movement/re-injury compared to home-training or advice [10–12]. A protocol of ET designed to address the impairments of neuromuscular control of chronic WAD may therefore prove effective in alleviating symptoms. Besides ET, a treatment based on postural control and awareness may also be effective. Postural assessment and treatment have long been a part of physiotherapy practice. The importance of normal upright posture has been proposed since the early 1900s [13]. Proper posture is believed to be a state of musculoskeletal balance that involves a minimal amount of stress or strain on the body [14]. Basic body awareness therapy (BAT) is a method that physical therapists use to improve patient awareness and control of posture [15]. BAT was developed in Sweden by Gertrud Roxendal [16] and is part of the curriculum at all Swedish Universities that offer physiotherapy education. The method is being increasingly used for treatment of chronic musculoskeletal pain disorders [17–28]. In a small uncontrolled clinical trial of BAT, patients with chronic WAD showed improvements in cognitive function, cervical range of motion and quality of life [29]. A pilot study of multi-modal rehabilitation for chronic WAD, that included BAT, demonstrated reductions in neck pain [30]. Nevertheless, all studies thus far have evaluated BAT as part of a treatment package and its efficacy as a single treatment for chronic WAD is unknown. The purpose of this trial was to compare the efficacy of ET and BAT for chronic WAD.

Disabil Rehabil, Early Online: 1–10

and/or measurement of outcomes (other painful conditions) and (2) had poor comprehension of the Swedish language. Settings and locations

Trial design

¨ lvsborg Hospital located Treatment was conducted at Southern A ¨ lvsborg County in Bora˚s, the largest city in the county. Southern A is located in the southwest of Sweden with a mixture of urban, village and rural living conditions, and a population of 270 000. The enrolment period was from March 2008 to February 2009. A small feasibility study was conducted in one fairly large primary health care centre. It showed that only 26% of patients attending with symptoms after a whiplash trauma were given a formal diagnosis of whiplash injury, while the word whiplash was found in the free text somewhere in their medical record of all patients. Only 4% of patients had the word whiplash in their medical record while not having been exposed to a whiplash trauma. It was therefore decided to initially include all patients with a formal diagnosis of whiplash injury and/or if the word whiplash was found anywhere in their electronic medical record, because the eligibility assessment would enable identification of whiplash-free patients before randomization. The extraction dates were set to 1–5 years before the beginning of the trial to ensure that only patients suffering from chronic WAD were identified. The search included the electronic medical records of all 30 ¨ lvsborg County and was primary health care centres in Southern A carried out in November 2006. Two physiotherapists were recruited to perform treatment. One physiotherapist held post-graduate training in Basic BAT was an accredited BAT-therapist and had over 10 years of experience of working exclusively with BAT. The other physiotherapist had equivalent proficiency in supervised exercise and had neither worked with nor received post-graduate training in BAT. Both physiotherapists were employed part-time by the project. The treatment provided in this trial was not part of routine care at the hospital but given in the form of a research project outside the regular flow of patients. For the purpose of this trial, the volume of care for the treatment centre can be considered zero. The reason for this is that the patients were recruited from primary care and would not normally have received care at the hospital.

Description of trial design

Interventions

This is a single-centre, randomized comparative clinical trial. The allocation ratio was 1:1. The trial was a joint effort between ¨ lvsborg Hospital, primary health care of Southern Southern A ¨ lvsborg County and the University of Gothenburg, Sweden. The A trial protocol was approved by the regional ethics review board (DNR 500-06) on 9 September 2006. The protocol has been registered with the Swedish National Registry of Research and Development Projects since November 2006 (available on-line at http://researchweb.org/is/sverige/document/1436).

Patients were not discouraged from seeking other health-care during treatment. They told that they were free to seek whatever treatment they desired and that they would be asked to report additional treatments at the follow-up. Both the treatments consisted of two 90-min sessions weekly for 10 weeks. Both the treatments used the same location during the same hours of the day but on different days of the week. Figure 1 displays a detailed description of the sequence of events and content of interventions as recommended by Perera et al. [31].

Methods

Participants Eligibility criteria The clinical examination to determine eligibility to participate in the trial was performed by the principal author, hereby referred to as the outcome assessor. To be eligible for inclusion patients were required to have had a whiplash injury of WAD grades I, II or III using the Quebec classification, report that they currently had pain and to have visited any of the 30 primary health care centres ¨ lvsborg County during 2001–2005, in other words in Southern A having had WAD grades I–III for a minimum of 1 year before trial commencement. Patients were ineligible if they: (1) suffered from any other comorbid conditions that would increase vulnerability to harm by the intervention (e.g. contraindication to exercise)

Exercise therapy Patients in the ET group were under supervision by a physiotherapist with experience and training in leading exercise groups. All patients trained together as a group (max 12 patients/group) to encourage social interaction and take advantage of the dynamics in a group. The exercise program was designed to include 45 min of muscle strengthening (whole body, neck and shoulders, and specifically targeting deep neck flexor muscles), aerobic exercise and coordination exercises; 15 min of stretching followed exercise, and then 20 min of progressive muscle relaxation at the end of the session. The goal was body conditioning and increased fitness as well as addressing dysfunction of the deep cervical flexor muscles and difficulties relaxing after exercise [32].

BAT or ET for WAD

DOI: 10.3109/09638288.2015.1044036 Time line

Exercise Therapy (ET)

Screening

A

Assessment

B

Baseline

C

Randomisation 1.5 hours of training twice a week for 10 weeks After treatment follow-up 3 months 3-month follow-up

A

B


Basic Body Awareness Therapy (BAT)

C

D

E

D

3

removing exercise components such as simultaneous arm movements, balance components, movement amplitude and frequency. Any adjustments of these exercises that the treating physiotherapist decided to use for individual patients were up to her and not standardized. The treating physiotherapist was not permitted to introduce new exercises that were not included in the written guideline.

E

Basic BAT C

C Patients with a formal diagnosis of whiplash injury and/or the term whiplash mentioned anywhere in the electronic medical record were contacted by posted survey. Written information about the trial was given and they were requested to fill in a questionnaire about WAD symptoms. Patients that had been exposed to whiplash trauma, had current neck/shoulder pain and wanted to participate were invited to visit the research centre. During the visit they were given information about the trial again. The inclusion and exclusion criteria were reviewed in order to decide whether the patient would be invited to participate in the trial. Informed consent forms were signed. The patient reported outcomes were collected: Short-Form 36 version 2 (SF-36), Neck Disability Index (NDI). Clinical examination was conducted. This involved brief motor and sensory examination to determine the patients’ WAD classification (I, II or III). The patients performed BAT in a group. The BAT physiotherapist (PT) led the group and chose from a bank of exercises (protocol available from authors) tailoring the content of each session according to her judgement of the patients’ ability. The PT performed the exercises together with the patients except for those performed in a lying position. Each exercise was performed as an exploration, trying to see how it feels, and not just following strict orders. Being mindful of what one is doing was encouraged. Light, effortless and playful movement was encouraged in every exercise. Focus was on trying to find how to perform every exercise while maintaining good posture, balance, unimpeded breathing and mental presence. The search for this quality of movement is itself thought to increase body awareness. Manual guidance was available but used with restraint. The PT used breaks, restarts, other exercises or variations of the exercise to help patients find movement quality. When the PT felt that patients were ready she suggested they try doing some exercises at home, starting with those exercises that felt most comfortable and moving slowly toward the rest. The exercises are explained in greater detail in the relevant BAT literature. The patients performed the exercise therapy supervised in a group. The concept was designed similarly to an aerobic fitness class and started with a 45-minute exercise session. The exercise session was structured as follows: warm-up, flexibility, whole-body strength, endurance, cervical flexor-muscle exercises, balance exercises, hand-eye-neck coordination and wind-down (protocol available from authors). Each exercise was performed with background music of appropriate beatsper-minute (bpm). The PT would help the patient adjust difficulty. This was done by adding or removing exercise components such as simultaneous arm movements, balance components, movement amplitude and frequency (more repetitions per bpm). 15 minutes of muscle stretching followed the exercise session. The muscles stretched were: Base of skull, Levator Scapulae, Trapezius, Scalenius, Sternocleidomastoideus, Triceps Brachii, Rhomboideus, Pectoralis, Gluteii, Iliopsoas, Quadriceps Femoris and Hamstrings. The class was concluded with 20 minutes of progressive relaxation. The relaxation was recorded on a CD and consisted of a narrator speaking to the patients over a calm music track. The relaxation was divided into progressive muscle relaxation where the patients flexed and relaxed each muscle in turn and felt the difference between contracted and relaxed muscle. The next stage consisted of relaxing each muscle in turn without first flexing it. During this stage the patients were guided to reinforce the relaxing response to the stimulus of taking a deep breath and slowly exhaling. The final stage consisted of becoming aware of one’s breathing and letting that movement take place without controlling when and how to breathe. Afterwards, the CD allowed for 3 minutes of resting in this relaxed state before guiding the patients to calmly rise and go on with their day.

Figure 1. Graphical depiction of trial components.

The content of ET was standardized using a set of exercises decided upon at the planning stage of the trial. These guidelines were in writing for reference. A CD recording of instructions was used for relaxation training. The physiotherapist would help the patient adjust the level of difficulty. This was done by adding or

Patients in the BAT group received a treatment program carried out under the supervision of a BAT physiotherapist. Patients were trained as a group (max 12 patients/group) for the same reasons as the ET group. The BAT program consisted of standard BAT exercises. These are based on activities of daily living (sitting, walking, lying down and standing), meditation and exercises inspired by Tai Chi. The goal was to become aware of how one uses the body and rediscover comfortable posture and efficient movement patterns. When performing each exercise, patients were asked to focus on adapting good posture, balance, unimpeded breathing, increased awareness and to reduce unnecessary muscle tension. The content of BAT was standardized using a set of exercises decided at the planning stage of the trial. This plan was kept in a written format for reference. If a patient had difficulty with an exercise, the physiotherapist would help the patient adjust the exercise. This was done using breaks, restarts and variations of the same exercise or switching to other exercises from the written plan. Feedback and manual guidance was provided by the physiotherapist but kept at a minimum to promote long-term carryover of motor learning [33]. Any adjustments of these exercises that the treating physiotherapist decided to use for individual patients were her decision and not standardized. The treating physiotherapist was not permitted to introduce new exercises not included in the written plan. Outcomes The primary outcome measures were perceived health-status with the Short Form 36 version 2 (SF-36) and neck pain disability with the Neck Disability Index (NDI). These patient-reported outcomes (PROs) were self-assessed by the patient. The PROs were collected three times for each patient included in the trial: prior to the beginning of treatment (T1), at the post-treatment follow-up (T2) and 3 months after treatment termination (T3). The SF-36 is a multi-purpose, short-form health survey with 36 questions. It yields an 8-scale profile of functional health and well-being scores. The eight scales are: physical functioning (PF), physical role functioning (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), emotional role functioning (RE) and mental health (MH). The scales score 0–100 with greater values indicating better health status. It is a generic measure, as opposed to one that targets a specific age, disease or treatment group. Accordingly, the SF-36 has proven useful in surveys of general and specific populations, comparing the relative burden of diseases, and in differentiating the health benefits produced by a wide range of treatments. SF-36 is sufficiently reliable for group level analyses, and evidence from many types of validity research supports its intended meaning [34,35]. The NDI is an instrument for assessing self-rated pain-related disability associated with activities of daily living in patients with neck pain. It consists of 10 items addressing functional activities and symptoms. Each item has six possible answers scoring 0–5 points for a maximum score of 50. Higher scores represent greater disability. The NDI has good reliability and moderate-to-good validity for patients with neck pain, including WAD [36,37].


4


Other outcomes measured were: pain frequency and intensity with 5-point categorical scales, the body awareness with the Body Awareness Scale [16], fear of movement/reinjury with the Tampa scale of kinesiophobia (TSK), cervical range of active angular motion with a CROM device and forward head posture with the goniometer method of Svensson. These outcomes were not analyzed in order to reduce the risk of mass-significance effects and will be used in other studies that will focus on investigating the significance of cervical posture in neck disability and the relationship between fear and other variables. Treatment compliance was measured by recording the number of appointments attended. The frequency and type of other treatments received outside the trial was recorded during the follow-up visits at T2 and T3. Information on harms was sought from all subjects using open-ended questions by telephone at T3. The trial did not use a list of harms but coded reports of harms into categories post-hoc. Patients not having received or discontinued treatment were encouraged to return for follow-up assessments. Sample size Separate calculations for each of the primary outcome measures were conducted to determine the sample size in each group at the planning stage of the trial in 2004. The power level was set to 80% at an alpha of 0.05. According to Appendix F, Table 7.4 of the Swedish manual and interpretation guide for SF-36 second edition [38], the sample size required to detect a 10-point difference is 55 for PF, 57 for BP, 43 for GH, 45 for VT, 53 for SF and 34 for MH. RP and RE required a sample size of 111 and 118, respectively. However, since RE and RP contain items heavily influenced by work status and the current trial was aimed primarily at health status, these domains were not considered in planning sample size. A calculation using a mean NDI value of 40.7 (SD ¼ 17) [39] results in a sample size of 46. An arbitrary between-group difference of 10 points was used for this calculation, since authors were unable to locate a reference value in the literature at the time the trial was being planned. The sample size was decided at approximately 60 for each group. This was chosen as a rounding-up of the sample size required for BP which was 57 to cover most items in primary outcome measures. Randomisation Implementation Five persons were involved in the trial: a preparator for the randomization procedure, a trial coordinator, an outcome assessor and two treating physiotherapists. The preparator was a staff member at the Research and Development Unit in Primary Health ¨ lvsborg, completely uninvolved in the trial Care of Southern A otherwise. He created the sequence generation and prepared the envelopes. The outcome assessor was not involved in treatment and had no knowledge of treatment allocation. He assessed eligibility, obtained informed consent and conducted the physical examination and gathered the PROs at T1, T2 and T3. The trial coordinator handled booking of appointments, mailing out PROs, trial administration and entering patient data from paper format into the statistical software but was not involved in assessment or treatment. The physiotherapists conducting treatment were not involved in the assessment of patients or any other parts of the trial. Sequence generation A computer-generated list of random numbers (0–99) and a table of random numbers were used to create the allocation sequence. Two computer-generated numbers determined which column and


row respectively to look up in the table of random numbers. The first digit of the random number found on the table of random numbers was selected. Odd numbers were assigned to ET and even numbers to BAT. Blocks of two were used so that group size could never differ by more than one patient. The allocation sequence was placed in sequentially numbered, sealed, opaque envelopes. The outcome assessor was given sealed envelopes and had no knowledge of any details of the randomization process. Allocation concealment If the patient was eligible and willing to participate the outcome assessor handed them the next numbered, sealed, opaque envelope with instructions to open it out of the view of the assessor (when they had left the building) and to contact the trial coordinator by phone to schedule participation. They had the option of participating in treatment 16:00–17:30 or 17:45–19:15. Patients were considered to have entered the trial after they left the eligibility assessment appointment. This process ensured that allocation was concealed to the outcome assessor. When the trial coordinator booked the T2 and T3 follow-ups for each patient, she reminded them to keep secret the type of treatment they had received from the outcome assessor. Blinding During follow-ups, the outcome assessor began the meeting by requesting the patient not to disclose the treatment received. Patients, treating physiotherapists and the trial coordinator were aware of the allocated treatment that as neither ET nor BAT can be administered in a blinded fashion. The outcome assessor remained blinded to allocation at all times. Statistical methods Data were analyzed by intention to treat, including all randomized patients in the analysis retained in the group to which they were allocated regardless of compliance to treatment. All randomized patients were invited to all follow-ups unless they decided to drop out, and their data were consequently missing. Change in outcome measures was calculated by subtracting baseline outcome scores from scores at follow-up. This was done for both T2 and T3 follow-ups. Mean changes between groups were compared by calculating p values using independent samples t test when skewness was below 1 and/or less than twice its standard error. When this criterion was not fulfilled, group comparisons used the Mann–Whitney U Test. Analyses were carried out with SPSS v.22 (Chicago, IL). Statistical significance was set at p50.05.

Results Participants Searching the electronic medical records of all 30 primary health care centres in the County identified 3570 patients during the period 2001–2005 with either diagnosed WAD or the word whiplash in the medical record text. A random sample of 1573 was selected because of financial restraints. The Swedish personal address registry (SPAR) had addresses to 1546. A survey was mailed to these patients and a reminder letter to non-responders a few weeks later. 996 patients (64.4%) responded to the survey, while 529 patients did not reply; 2 were deceased; 2 were living abroad; and 17 letters were returned since the addressees were unknown. From the 996 responders, 567 declined participation in the trial, 17 replied that they had not suffered a whiplash trauma, 28 had a pain frequency of never/almost never, 11 replied after deadline and could not be included in the trial and 1 was missed by administrative error and did not participate. Space and time

BAT or ET for WAD

DOI: 10.3109/09638288.2015.1044036

Fifty-seven (44 women, 13 men) patients were allocated to ET and 56 (37 women, 19 men) to BAT. Four patients received no treatment. One patient in each group decided not to participate in the trial after randomization without stating a reason. The remaining two patients had been randomized to BAT treatment but could not participate because of work (n ¼ 1) and having moved away (n ¼ 1). By T2 eight patients in the ET group and four in the BAT had discontinued treatment (reasons reported in Figure 2). One patient in the ET group and three in the BAT group were lost to follow-up. Outcome measures were not available for all patients at all follow-ups, because some patients did not fill in all the PROs or did not participate in all follow-ups. The exact

Enrollment

Assessed for eligibility (n=372)

Follow-Up

Allocation

Randomized (n=113)

Analysis


limitations made it impossible to treat all patients simultaneously. Three 10-week periods of treatment were therefore conducted: spring 2008, fall 2008 and spring 2009. 372 reported history of whiplash trauma, current neck pain and willingness to participate in the trial and were invited for a visit to the research centre to assess their eligibility by clinical examination and history taking. 176 visits took place during March 2008, August 2008 and January 2009. 113 patients met the inclusion criteria and were randomly assigned to treatment. By then the pool of patients available to be assessed had been exhausted. The flow of participants and reasons for not participating in the trial are presented in Figure 2.

Excluded (n=259) Unable to contact the patient (n=73) Not meeting inclution criteria (n=63) • Comorbidity that hinders participation (n=39) • Recovered (n=15) • Had trauma but not WAD (n=7) • Pregnant (n=1) • Cannot speak Swedish (n=1) Declined to participate (n=115) • I have no time for this (n=62) • Can’t because of work (n=21) • Not interested (n=11) • Learned to live with it (n=3) • Treatment too intensive (n=12) • Declined without stating reason (n=6) Other reasons (n=8)

Allocated to exercise therapy (n=57) Received allocated intervention (n=56) Did not receive allocated intervention (n=1) • Decided not to participate after all

Allocated to Basic Body Awareness Therapy (n=56) Received allocated intervention (n=53) Did not receive allocated intervention (n=3) • Decided not to participate after all • Work-related reasons • Moved away

Lost to follow-up (n=1) Panic disorder

Lost to follow-up (n=3) • Decided not to participate after all • Family reasons • Depression

Discontinued intervention (n=8) • Inflammation in shoulder and knee worsened by exercise • WAD symptoms worsened by therapy (n=2) • No reason given • Inflammation in both arms • Doesn’t believe this therapy can help • Other health issues • Panic disorder

Analysed (n=56) • No patients were excluded from analysis

5

Discontinued intervention (n=4) • Family reasons • WAD symptoms worsened by therapy • Depression • Doesn’t believe this therapy can help

Analysed (n=53) • No patients were excluded from analysis

Figure 2. Participant flowchart.


6



number of data points in the analysis of each outcome is indicated, where appropriate, as N. The mean age in the ET group was 48.7 (SD 1.3) years, and in the BAT group mean age was 47.4 (SD 13.3). The patients in the ET group had a mean of 1.7 (SD 1.2) whiplash traumas and a mean of 9.3 (SD 7.7) years duration of WAD. Patients in BAT group had a mean of 1.8 (SD 1.4) whiplash traumas and a mean of 10 (SD 9.5) years duration of WAD. There were no statistically significant differences between groups at baseline. More details on the clinical characteristics of patients in each group are presented in Table 1. The planned total number of treatment visits was 20 (twice weekly, 10 weeks). Mean compliance in ET group was 12.9 (95% CI 11–14) visits and in the BAT group 14.3 (95% CI 13–16) visits. A Mann–Whitney U Test revealed no significant difference in compliance (p ¼ 0.068). At T1 the ET group had one patient with WAD classification grade I, 16 with grade II and 40 with grade III. The BAT group had 13 patients with grade II and 43 with grade III. A total of 18 change scores were constructed for the NDI and the eight scales of SF-36 to compare groups at T2 and T3. 113 patients had 18 change scores for a total of 2034 values in the data file. 156 (7.67%) values were missing. All 18 change scores had

missing values. 93 (82.3%) patients had complete data, while 20 (17.7%) patients had missing data. Other treatment received At T2, 25 patients (47%) in the ET group and 21 patients (42%) in the BAT group reported seeking additional treatment. At T3, the corresponding figures were 29 patients (57%) in the ET group and 22 patients (45%) in the BAT group. An independent samples t test revealed no significant difference in additional treatment received outside the trial at T2 (p ¼ 0.602) or T3 (p ¼ 0.236). The frequency and type of additional treatment reported at T2 and T3 are shown in Table 2. Comparisons between treatments From baseline to T2, patients in the BAT group increased their physical functioning (median 5, IQR ¼ 15) more than patients in the ET group (median ¼ 0, IQR ¼ 15), p ¼ 0.032. No other differences were statistically significant between the groups. Table 3 presents the changes in outcomes from T1 to T2. Three months after the end of treatment (Table 4), at T3, patients in the BAT group had less bodily pain (m ¼ 17.5, 95% CI 6.9–17.6) than patients in the ET group (m ¼ 4.9, 95% CI 0.1 to

Table 1. Baseline characteristics for exercise and BAT group. Variable Age, years Female Male Duration of symptoms, years WAD classification 1 2 3 Number of whiplash traumas Neck Disability Indexa SF-36 v2 Physical functioningb SF-36 v2 Role – physical SF-36 v2 Bodily pain SF-36 v2 General health SF-36 v2 Vitality SF-36 v2 Social functioning SF-36 v2 Role – emotional SF-36 v2 mental health Tampa scale of Kinesiophobiac a

Statistic

Total (n ¼ 113)

ET (n ¼ 57)

BAT (n ¼ 56)

Mean (SD) Md (Range) N (%) N (%) Mean (SD) Md (Range)

48.1 48 81 32 9.7 7

(12.3) (18–79) (71.7%) (28.3%) (8.6) (1–48)

48.7 47 44 13 9.3 7

(11.3) (23–79) (77%) (23%) (7.7) (1–47)

47.3 49 37 19 10 7

(13.3) (18–72) (66%) (34%) (9.5) (1–48)

N (%) N (%) N (%) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range) Mean (SD) Md (Range)

1 29 83 1.79 1 19.4 19 68 75 29.8 0 34.7 41 50.8 50 37.7 40 59.3 50 54 66.66 64.3 72 35.9 36

(0.9%) (25.7%) (73.5%) (1.3) (1–10) (8.3) (2–37) (19.7) (15–100) (39.2) (0–100) (18.9) (0–84) (20.8) (5–97) (23.2) (0–85) (27.6) (0–100) (43.5) (0–100) (23.3) (8–96) (9) (18–68)

1 16 40 1.7 1 18.8 18 69.7 75 24.5 0 35.2 41 48.7 50 35.1 30 59.4 50 51.7 33.33 62.7 68 35.3 36

(2%) (28%) (70%) (1.2) (1–8) (7.6) (2–36) (17.5) (15–100) (37.3) (0–100) (18.2) (0–84) (18.7) (15–97) (22) (0–80) (27.2) (0–100) (44.5) (0–100) (24) (8–96) (7.6) (18–53)

0 13 43 1.8 1 20 20 67.5 75 33.9 12.5 34.3 41 54.7 57 39.5 42.5 60 62.5 55.4 66.66 65.9 72 36.6 35

(0%) (23%) (77%) (1.4) (1–10) (8.9) (4–37) (21.3) (20–95) (39.4) (0–100) (19.7) (0–72) (22.5) (5–92) (23.9) (5–85) (27) (0–100) (41.8) (0–100) (21.8) (8–96) (10.5) (19–68)

p Valuea 0.681 0.270 0.971

0.407 0.733 0.533 0.854 0.172 0.895 0.104 0.409 0.774 0.707 0.629 0.800

Differences between groups at baseline were tested with Mann–Whitney U tests except for gender and WAD classification which were tested with chi-square test for independence. Neck Disability Index score (0–50 scale, 10 items, higher scores represent greater disability). c Short Form 36 version 2 score (0–100 scale, 36 items, higher scores represent a better health state). d Tampa Scale of Kinesiophobia score (17–68 scale, 17 items, higher scores represent greater pain-related fear of movement). b

BAT or ET for WAD

DOI: 10.3109/09638288.2015.1044036

9.8), p ¼ 0.044. Patients in the BAT group had also increased their social functioning (m ¼ 13.3, 95% CI 6.6–19.9) more than patients in the ET group (m ¼ 3.5, 95% CI 3 to 9.9), p ¼ 0.037. No statistically significant differences between the groups were found for the change of other outcomes. Adverse events One hundred and five of 113 patients were asked about adverse events. Four patients did not participate in treatment at all. Another four patients could not be reached by telephone, and their adverse events data are missing. No serious adverse events were reported during this trial or in connection to treatment. One patient suffered a partial calf muscle rupture during the visit

7

to participate in the T2 follow-up and was in need of medical attention. This minor injury subsequently healed and symptoms receded completely. The patient was not excluded from the analysis. Patient-reported adverse events are presented in Table 5. Four patients in the ET group and one in the BAT group reported that they discontinued treatment due to harms, as seen in Figure 2. A Fisher’s exact test found no statistical significant difference in the frequency of harms leading to discontinued treatment (p ¼ 0.363). The event rate for all adverse events was 0.4 in the ET group and 0.27 in the BAT group. A chi-square test found no difference in the frequency of all adverse events between groups (p ¼ 0.240).

Discussion


Table 2. Self-reported additional treatment received outside the study at the post-treatment and three-month follow-up. T2

T3

ET (n ¼ 53)

BAT (n ¼ 50)

ET (n ¼ 51)

BAT (n ¼ 49)

28 6 12 10 0 9

29 8 7 12 2 3

22 10 15 3 1 10

27 9 9 9 0 5

No additional treatment Physical and manual therapy Massage Physical activity/Exercise Surgery Miscellaneous

In this randomized comparative clinical trial of group training for patients with chronic WAD, a 10-week treatment regimen of twice-weekly, 90-min sessions of BAT produced a greater increase of physical functioning than ET of equal intensity and duration. Three months after the end of treatment, improvements in bodily pain and social functioning were greater for the BAT group than the ET group. There is a trend to significance (p ¼ 0.07) that NDI improved more (effect size 0.37) in the BAT group (m ¼ 2.3, 95% CI 3.3 to 1.2) than in the ET group (m ¼ 0.6, 95% CI 2 to 0.9) at T2. Likewise, there is a trend to significance (p ¼ 0.096) that the improvements in social functioning were already greater (effect size 0.33) for the BAT group (m ¼ 12.7, 95% CI 7.1–18.4) than

Table 3. Changes in outcomes from T1 to T2 for exercise (ET) and basic body awareness (BAT). Mean change (95% CI)

N

b

NDI Physical functioningc Role – physical Bodily pain General health Vitality Social functioning Role – emotional Mental health

ET

BAT

50 54 54 54 54 54 54 54 54

48 52 52 52 52 52 52 52 52

ET 0.6 0.1 12.4 5.4 4 5.4 5.6 12.7 4.2

Median (Interquartile range) BAT

(2 to 0.9) (3.6 to 3.8) (0.6–24) (0.6–10.2) (0.1–7.9) (0.7–10.1) (0.9 to 12) (0.9–24.4) (0.5 to 8.8)

2.3 7.6 16.8 10.6 8.3 10.8 12.7 14.1 3.5

(3.3 to 1.2) (3.7–11.4) (6.4–27.3) (6.2–15) (3.6–12.9) (5.8–15.8) (7.1–18.4) (1.1–27.1) (1.5 to 8.6)

ET 0 0 0 9 2.5 5 0 0 4

(6) (15) (50) (28) (20) (22.1) (28.1) (33.3) (16)

BAT 2 5 25 10 10 12.5 12.5 0 4

(5) (15) (25) (21.8) (25.3) (23.8) (25) (33.3) (27)

p Valuesa

Effect size Cohen’s d

T test

0.37 0.54 0.11 0.31 0.27 0.3 0.33 0.03 0.03

0.070

Mann–Whitney 0.032

0.569 0.110 0.165 0.120 0.096 0.441 0.859

a

Skewed variables were analysed non-parametrically. Neck Disability Index score (0–50 scale, 10 items, higher scores represent greater disability). c Short Form 36 version 2 score (0–100 scale. 36 items. higher scores represent a better health state). b

Table 4. Changes in outcomes from T1 to T3 for exercise (ET) and basic body awareness (BAT). Mean change (95% CI)

N

b

NDI Physical functioningc Role – physical Bodily pain General health Vitality Social functioning Role – emotional Mental health a

ET

BAT

51 54 54 54 54 54 54 54 54

48 50 50 50 50 50 50 50 51

ET 1 0.5 19 4.9 4.5 5.6 3.5 4 1.2

(2.5 to 0.4) (3.2 to 4.1) (9.3–28.6) (0.1 to 9.8) (0.1 to 9) (0.5 to 11.6) (3 to 9.9) (8.3 to 16.4) (3.6 to 5.9)

Median (Interquartile range) BAT

2 7.1 17.5 12.2 7.5 7.3 13.3 9.3 2.8

(3.5 to 0.5) (3.1–11.1) (5.9–29) (6.9–17.6) (2.4–12.6) (1–13.6) (6.6–19.9) (2.3 to 21) (2 to 7.6)

ET 0 0 0 4.5 5 5 0 0 0

(6) (15) (50) (14.3) (24) (30) (25) (33.3) (22)

BAT 2.5 5 0 10.5 8 5 12.5 0 4

Skewed variables were analysed non-parametrically. Neck Disability Index score (0–50 scale, 10 items, higher scores represent greater disability). c Short Form 36 version 2 score (0–100 scale, 36 items, higher scores represent a better health state). b

(9) (15) (50) (22) (25) (30) (25) (33.3) (24)

p Valuesa

Effect size Cohen’s d

T test

0.18 0.48 0.04 0.4 0.17 0.08 0.41 0.12 0.09

0.368

Mann–Whitney 0.071 0.962

0.044 0.383 0.688 0.037 0.532 0.641


8



Table 5. Adverse events.

for the same biomechanical load [50,51]. Finally, patients with WAD have a decreased ability to relax these superficial muscles compared to healthy controls [32,52]. A study by Sterling et al. [45] found that impairments in JPS and increased superficial cervical muscle activity are present in patients with WAD within 1 month of the injury. In this study, impaired JPS at 1 month was associated with persistent moderate/severe disability at 3 months, while increased activity in the superficial flexor muscles of the neck persisted at 3 months regardless of whether subjects were disabled or recovered. Both impaired postural control/awareness (forward head posture, JPS deficits) and abnormal muscle function (reduced strength/endurance, dysfunctional activation and inability to relax) may therefore be plausible targets of treatment for chronic WAD. Earlier studies by Bunketorp et al. [10], Stewart et al. [11] and Jull et al. [12] had demonstrated the efficacy of ET in the treatment of subacute and chronic WAD. This finding was not repeated in the present trial, however. This may have been due to differences in the duration of symptoms or related to the choice of exercises. Patients in the aforementioned studies had suffered from WAD for a mean 2.1, 9 and 12.6 months, respectively. This was far shorter than the mean 9.7 years in the present trial. This could be a maturation bias effect related to symptom duration. An alternative explanation may be that some patients respond to exercise and some experience an exacerbation of symptoms. The patients that could respond to exercise may have already done so during previous treatments over the years and therefore may be missing from the sample. A third alternative may be that a distinction needs to be made between which patients need to exercise and how [53]. A study of endogenous pain inhibition during exercise in patients with mean 6.8 years of WAD reported worsening of symptoms post-exercise and a decrease of pain pressure thresholds for submaximal exercise and similar though smaller effects for self-paced exercise [54]. The impaired pain inhibition may explain the lack of efficacy observed for ET in the present trial. Four patients in the ET group discontinued the intervention because of symptom worsening and one patient in the BAT group. The present trial was not designed to measure harms so the hypothesis of increased treatment drop-outs in ET needs to be further investigated.

ET No adverse event Increased pain Back pain Hip pain Nausea Didn’t receive treatment Could not be reached Total BBAT No adverse event Increased pain Fatigue Increased headache Training soreness Didn’t receive treatment Could not be reached Total

Frequency

Percent

32 18 1 1 1 1 3 57

56.1 31.6 1.8 1.8 1.8 1.8 5.3 100

38 10 2 1 1 3 1 56

67.9 17.9 3.6 1.8 1.8 5.4 1.8 100

in the ET group (m ¼ 5.6, 95% CI 0.9 to 12) at T2. Since these p values fall outside the critical level of 0.05 that we are willing to accept we have decided to keep the null hypothesis. The effect sizes suggest that there is a valid difference between groups in NDI and social functioning at T2, but the sample size may have been insufficiently large to reach statistical significance. A similar finding may have occurred at T3 where there was a trend to significance (p ¼ 0.071) that physical functioning was still more improved (effect size 0.48) in the BAT group (median ¼ 0, IQR ¼ 15) than in the ET group (median ¼ 5, IQR ¼ 15) but below the critical level of 0.05. Note that two patients from the BAT group were lost to follow-up at T3 but the effect size was comparable, from 0.54 at T2 to 0.48 at T3. This may suggest that the lack of statistical significance was related to the small sample size but that there is a valid difference in physical functioning between the groups at both the follow-ups. The statistically significant improvements in these outcomes may explain why clinicians and patients with chronic pain have positive experiences of BAT [18]. At the same time, the change scores of SF-36 domains that improved ranged from 5 to 13.3 points, indicating that improvements were small to moderate [38]. The same conclusion can be reached by evaluating the effect sizes for these improvements (range 0.4–0.54). This finding is in line with our understanding of chronic WAD as a difficult to treat, persistent disorder [4]. Patients with WAD present impairments in the ability to determine exactly where a particular body part is in space. Impaired joint position sense (JPS) of the head, neck and upper extremities has been demonstrated in several studies [40–44]. This impairment is clinically relevant, since it explains a substantial amount of the patients’ perceived health-status (SF-36 domains: physical functioning, social functioning and vitality), disability (Pain Disability Index) and ratings of functional self-efficacy (Self Efficacy Scale) [43]. In fact, greater JPS impairment is associated with higher scores on the Neck Disability Index [45], dizziness [46], upper limb radiculopathy signs and symptoms, and decreased active range of cervical motion [47]. Numerous studies have demonstrated a reduction in both overall strength and endurance of the cervical muscles as well as specific weakness in the deep flexors and extensors in patient samples with various types of neck pain and/or headache [48,49]. Additionally, the superficial cervical muscles, such as the trapezius, sternocleidomastoideus and anterior scalenes, show much greater activity in these patients than in healthy individuals

Limitations The probability sampling method used in the current trial identified all WAD patients within a well-defined geographic area that had contacted primary health care during the years 2001–2005. Even though probability sampling increases the generalizability of results, there remains a risk for self-selection bias in the sample. The patients may have no longer been receiving treatment at the time they were contacted but they decided to participate in a treatment comparison trial when asked. It is impossible to say how the patients that did not reply to the survey or declined to participate differed from participants, but the reasons given for declining to participate (Figure 2) suggest that these decliners had less severe symptoms. Based on the rate of WAD grade III in the sample, we speculate that patients had more bothersome symptoms than the average chronic WAD population. This is not a threat to internal validity but may have implications on which population the inference is generalizable to. Another limitation of the trial may be the similarities between treatments. The current trial is, in the authors’ knowledge, the first to directly compare the efficacy of these treatments. Both treatments were delivered in the same manner and under similar frequency and intensity in order to make a fair

DOI: 10.3109/09638288.2015.1044036

comparison. Results may be different if treatments are administered with different frequency or intensity. Because both treatments involved relaxation of some sort it may be that the treatments were not sufficiently different.


Generalisability There were more women (71.7%) than men (28.3%) and more patients with WAD grade III (73.5%) than grade II (25.7%) in this trial. Both the female gender and radicular symptoms have been shown to be associated with poorer prognosis, thus this finding is not unexpected among patients with chronic WAD and consistent with previous research [55,56]. Patients were recruited from all primary health care centres of the county with probability sampling and had a mean duration of symptoms of 9.7 years. We therefore assume that the results of the current trial are generally applicable to patients with chronic WAD in primary care. The sampling method, statistical power, sequence-generated allocation and blinded assessment make conclusions credibly generalizable to the intended population of patients.

Conclusion This randomized comparative clinical trial found greater improvement in Physical Function for BAT than ET following a 10-week treatment regimen of twice-weekly, 90-min sessions. Three months after treatment patients in the BAT group had less bodily pain and greater social functioning than patients in the ET group. Further studies are necessary to investigate which patients benefit from treatment, whether the treatments differ in the event rate of harms and long-term outcomes.

Acknowledgements We thank the Psychiatric Physiotherapy Unit Bjo¨rka¨ngen for providing a location for the trial site. The authors would also like to thank all who took part in the intervention and enabled the trial to take place.

Declaration of interest The authors report no declarations of interest. This trial was funded by research grants VGFOUREG-11419, VGFOUREG24191, VGFOUREG-5525 by the The Health & Medical Care Committee of the Region Va¨stra Go¨taland and grants VGFOUSA162631, VGFOUSA-38041, VGFOUSA-43901, VGFOUSA87931 by the Research and development council of the county ¨ lvsborg. Aris Seferiadis’ research post was in part funded So¨dra A ¨ lvsborg Hospital and by the Health Care Strategy Unit at So¨dra A the Research Fund of the Division Management of Psychiatry at ¨ lvsborg Hospital. So¨dra A

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