Journal of Orthopedic Research & Physiotherapy Category: Medical Type: Research Article
The Long-Term Effect of an Outpatient Intervention Program with a Behavioral Therapy Approach in Patients with Chronic Back or Neck Pain with a Focus on Psychosocial Aspects
- Peter Machacek1, Florian Wepner1, Joerg Holzapfel1, Julia Hahne2*, Martin Friedrich1
- 1 Orthopedic Hospital, CEOPS (Center Of Excellence For Orthopedic Pain Management Speising), Speisingerstarsse, Vienna, Austria
- 2 Center Of Excellence For Orthopedic Pain Management Speising, Orthopedic Hospital Vienna, Speisingerstrasse 109, 1130 Vienna, Austria
*Corresponding Author:Julia Hahne
Center Of Excellence For Orthopedic Pain Management Speising, Orthopedic Hospital Vienna, Speisingerstrasse 109, 1130 Vienna, Austria
Tel:+43 1 80 1 82 1583,
Received Date: Aug 13, 2015 Accepted Date: Oct 05, 2015 Published Date: Oct 19, 2015
Objective: Success of outpatient intervention programs consisting of physiotherapy in patients with non-specific chronic back or neck pain has not been conclusively proven. Greater attention to psychosocial factors may improve outcome. We investigated whether an outpatient intervention program with a behavioral therapy approach would exert a long-term effect on non-specific chronic back or neck pain specifically on patients with pronounced fear avoidance behavior and/or with psychosocial limitations.
Design: Prospective, randomized controlled trial.
Subject/Patients: 121 patients were assigned to either the intervention or control group. The intervention group received a program of 9 units physiotherapy and 2 units occupational therapy, conducted with a behavioral therapy approach. The control group received standard care.
Methods: Efficacy of treatment was evaluated after 6 and 58 weeks by measurements of pain, quantity of painkillers, sick leave days, disability, health related quality of life, and fear avoidance.
Results: The intervention group consumed significantly less painkillers after 58 weeks and showed reduced fear avoidance behavior after 6 weeks. No significant associations were observed between patients with high or low fear avoidance and pain severity, days of sick leave, health related quality of life, or disability.
Conclusion: An outpatient intervention program is not sufficiently effective in the long term when administered without due regard to accompanying psychosocial factors.
Study design and approach
The main hypothesis of our research project was that a standardized training program would have effects on pain levels (measured with visual analog scales), compared with a control group that only received usual care. Secondary hypotheses dealt with the intake of pain killers, number of sick leave days, disability, health related quality of life and fear avoidance behavior.
Participants and recruitment
Members of the IG received 9 units of Physiotherapy (PT) and 2 units of Occupational Therapy (OT), each lasting one hour. Every patient of the IG was trained to perform either a neck or back intervention program specifically suited to his/her needs. Prior to the start of the 6-week training program, each test person received an individual introduction of 1 hour by a physiotherapist, which was adjusted to the specific needs (neck or back). The single session was conducted by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed 8 group training units with a maximum number of 8 participants, over a maximum period of six weeks. The patients were not permitted to miss more than 2 units of the PT sessions.
The physiotherapeutic intervention program was designed as circuit training and was supervised alternately by one of the physiotherapists, who adhered to standardized care guidelines. The aims in this part were strengthening of the muscles of the trunk and cervical spine as well as transporting the idea of joy in physical activity and active dealing with pain. This was primarily achieved by activating deep stabilizers of the lumbar spine and deep flexors of the cervical spine in combination with the superficial abdominal muscles and muscles of the spine and shoulder girdle . Further emphasis was put on training of coordination by improving the sense of balance. Coordination abilities were trained by means of balance exercises. The exercises were designed to be performed by persons of all proficiency levels. The exercises could also be performed at home with minimal equipment (a Theraband® was handed out to each patient). For each exercise, the level of difficulty could be increased by altering the motion, increasing the number of repetitions or weights. This was recorded by the patients on a special protocol for every training unit and every exercise. All participants received the intervention program in writing, together with pictures and explanations of the drills. This was also done for the purpose of documentation. Each patient was free to select the order of exercises, but had to complete all exercises in one training unit. Attention was given to the execution quality of the exercises, which was checked on an ongoing basis. The patients were instructed to perform the exercises regularly at home.
During the entire intervention phase, behavioural therapy measures based on those proposed by Butler and Mosley  were performed. Patients were advised not to focus on the pain and to continue daily activities without restrictions. They were educated that physical activity does not lead to tissue damage and, on the other side, inactivity can support chronic pain.
Specifically, associations between fear avoidance behavior and chronic back pain were investigated, and motivational aspects identified.
|Lumbar spine training||Cervical spine training|
|Prior to each exercise||Activation of M. transversus abdominis obtaining a neutral position of the lumbar spine||Activation of the deep flexors of the neck obtaining a neutral position of the cervical spine|
|1||Squats with barbells||Push-ups against the wall/on the floor|
|2||Cable winch, squat position, extension of the shoulder from flexed position||Sedentary position, pulling latissimus towards chest|
|3||Training of abdominal muscles, extension/flexion in horizontal position (monitoring of position of the lumbar spine with blood pressure cuff)||Training of the deep flexors of the neck in horizontal position using a blood pressure cuff|
|4||Small rotations of the thoracal spine in squat position||Military press with dumbbells|
|5||Resting on lower arm, leg exercises||Shrugs with dumbbells|
|6||Standing position, extension/flexion against resistance provided by the Thera band®||Rotations of the thoracal spine in sedentary position|
|7||Training of balance-coordination with a spinner||Stabilisation of the cervical spine using a Thera band® wrapped around the head|
|8||Training of balance-coordination with spinner|
In the two units of occupational therapy the patients were divided into a group that primarily performed sedentary activities or a second group that primarily performed heavy physical work depending on their profession. The aims were to encourage the knowledge about ergonomics in everyday - life and to strengthen physical perception. The goal was to offer patients an alternative way to handle their pain. In the first unit, a lecture was given to the participants on basic knowledge regarding ergonomics in everyday-life followed by a hands-on training of relevant situations (e.g., lifting with activated basic tension). The second unit (build-up session) included an analysis of the individual work-situation of the participants in small groups, and helped to implement possibilities for optimizing their general working conditions.
During the sessions, compliance with the therapy was observed by the PTs and patients were encouraged to give feedback about their training progress.
To evaluate the main hypothesis, current pain and mean pain during the preceding week and the preceding 3 months were determined on a Visual Analog Scale (VAS; 0-100, lower scores indicate less severe pain).
The Oswestry Disability Index (ODI, the higher the values, the higher the limitation of activity; scale 0-100) [26,27] was used to measure functional impairment. To evaluate health related quality of life, we used the 36-item short form health survey (SF-36; scales 0-100, Lower scores indicate poorer mental and physical quality of life) . Anxiety, insecurity in social contacts and compulsiveness were registered on the Brief Symptoms Inventory (BSI), which is an abridged version of SCL-90-R [29,30]. The BSI addresses subjective experience of impairment based on a list of symptoms that are partly physical and partly psychological in a time frame of seven days. Thus, it is not a measurement of stable (personality) traits.
At time point 1 and 3, the number of (self-reported) days of sick leave due to pain during the preceding twelve months and the number of painkillers taken per day were inquired. Fear avoidance behavior was determined by means of the Fear Avoidance Beliefs Questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs) . For further evaluation, patients demonstrating strong Fear Avoidance Behavior (FABQ cut-off value>29) were compared to those with milder Fear Avoidance Behavior (FABQ cut-off value<28).
In the first step we assessed whether and to what extent study drop-outs differed from study participants in terms of selected basic variables. Concerning the variables of gender, group (IG vs. CG; occupational therapy group, physiotherapy group), training and marital status, this question was investigated by means of chi-square tests. Regarding age, days of sick leave before inclusion in the study, VAS, and the number of years since the onset of pain, mean value comparisons were performed by means of t-tests for independent random samples.
Statistical evaluation of the primary hypothesis (change in the number of days of sick leave during one year after therapy at least in one of the groups) was performed by means of two-fold variance analysis for repeated measurements. A prerequisite for this test procedure was homogeneity of variances in the individual subgroups. These were tested by means of Levine’s test. Normal distribution of values within a group was checked visually on histograms. Secondary hypotheses (impact of the therapy on the severity of pain, health-related quality of life, disease-related limitations, fear avoidance behavior) were also investigated by means of variance analyses of repeated measurements. Tests for violation of prerequisites were checked by visual control of histograms. Significances between the individual time points were determined by means of contrast analysis. The limit for the significance of a contrast was set to 0.05.
BSI scale values were transformed into t-values, which express associations with the normal population. All persons who had t-values<60 were assigned to an “affected” group for each sub-scale. The term “affected” in this context did not necessarily refer to a patient with noticeable clinical features, but that the symptoms were more severe than those in the normal population. For further evaluation, changes in the individual affected groups were determined in relation to VAS, ODI, FABQ and the SF-36.
Figure 1: Flow chart depicting recruitment, randomization and retention of participants.
The two groups did not differ significantly in terms of most baseline data at the onset of the study. However, in the mean VAS of the preceding week the CG had significantly higher baseline values (Table 2).
|Training Group||Control Group||p|
|Age [mean (SD)]||39.13 (6.955)||38.55 (7.942)||0.698|
|BMI [mean (SD)]||25.62 (4.135)||26.02 (5.613)||0.689|
|Days of sick leave [mean (SD)]||10.91 (7.326)||11.23 (7.529)||0.832|
Extent of employment (%)
Marital status (%)
|Pain intensity 3 month [mean (SD)]||36.00 (22.558)||40.80 (25.272)||0.320|
|Pain intensity 1 week [mean (SD)]||34.38 (23.006)||44.02 (23.719)||0.053|
|FABQ [mean (SD)]||29.30 (16.145)||29.34 (14.717)||0.990|
SF36 [mean (SD)]
48.60 (7.339)51.55 (8.007)
45.74 (7.483)49.29 (9.486)
|Number of years since the onset of pain [mean (SD)]||
Study dropouts differed significantly from those who remained in the study at time point 1 only with reference to the VAS time frame of 1 week (p=0.001). Study dropouts had less pain (VAS 35±2.5 vs. 20±3.6). All other variables-including the VAS time frame of 3 months-revealed no significant differences.
Evaluation of the exercise protocols of members of the training group after the last group physiotherapy session revealed a significant improvement in the number of repetitions and an increase of training weights over time in regard of all exercises.
VAS dropped at time point 2 in both groups. After one year the CG revealed a further drop in VAS while the IG showed a slight increase (Table 3). The results, however, were not significant - neither over time nor between groups.
VAS 7 days, TP 1 Training group
VAS 7 days, TP 2 Training group
VAS 7 days, TP 3 Training group
At time point 3 the IG showed a significantly lower intake of painkillers compared to time point 1 (χ2 test, p=0.002). The intake of painkillers was reduced in the CG as well, but the reduction between time point 1 and time point 3 was not statistically significant (χ2 test, p=0.067).
At time point 1 and 3 the two groups did not differ significantly with regard to the intake of painkillers (time point 1: χ2 test, p=0.801; time point 3: χ2 test, p=0.765).
Regarding ODI, a significant time effect was noted in both groups at time point 2 (p=0.020), but no significant group effect was noted (Figure 2).
Figure 2: Mean Scores and standard deviation of the Oswestry disability index (extract from the 0-100 scale), TP=time point.
For SF 36, neither the physical nor the mental total score revealed a significant group or time effect at the three time points.
As regards the number of (self-reported) days of sick leave, significantly fewer days were registered for both groups over time (mean sick leave days at time point one: 10.6; at time point two: 5.29 days; p=0.000). No significant differences between the two groups were noted (p=0.965).
As regards the above mentioned data, no significant differences were observed between patients with neck pain as well as those with back pain.
With regard to FABQ, strong but non-significant group effects were noted after the intervention (time point 2). Patients in the behavior therapy-oriented group had markedly better values than the CG. At time point 3 these differences were largely nullified (Figure 3).
Figure 3: Mean Scores and standard deviation FABQ (Scale: 0-66), TP=time point.
After the groups had been divided into persons who demonstrated mild Fear Avoidance Behavior (FABQ score 28 or lower; 52% of the random sample) and those with marked Fear Avoidance Behavior (FABQ score 29 or higher; 48% of the random sample) at time point 1, in the IG the fear avoidance behavior of persons with a high FABQ score was markedly improved in the short term. Here a significant drop in values (p=0.015) was noted compared to time point 2. However, the same group experienced a slight increase in values after one year (Figure 4), but these values did not differ significantly from those at time point 1. Persons with a low FABQ score at time point 1 generally demonstrated less change in their fear avoidance behavior. In the CG, patients with high values at time point 1 did not demonstrate significantly less pronounced fear avoidance behavior at time points 2 and 3.
Figure 4: FABQ-behavior of persons with low and high baseline values (Scale: 0-66), mean scores and standard deviation, TP=time point.
In the investigated population we observed a significant (r=0.338, p=0.001) correlation between FABQ scores and the severity of pain. In other words, persons with high FABQ scores reported more severe pain at time point 1 in our population.
However, no significant associations were observed between patients with a high and a low FABQ score, and a change in the intensity of pain, the number of days of sick leave, SF-36, or the ODI, independent of group membership.
Evaluation of the BSI revealed significant results only in those patients who were remarkable in terms of somatization. Thus, a significantly stronger resurgence on the VAS scale (time frame of one week) and the FABQ was registered between time point 2 and time point 3, independent of group membership (IG or CG).
The only significant difference between the groups after one year was a reduction in the intake of painkillers in the IG. As regards pain, after one year no major differences were noted-neither between groups nor over time. Of course this lack of a significant difference may have also been due to the lower intake of painkillers in the intervention group after one year, but this appears to be unlikely in view of the absence of significant group differences in FABQ, ODI or SF-36 scores. The number of days of sick leave was also reduced in both groups, with no significant difference between groups.
As regards fear avoidance behavior, especially patients with high FABQ scores demonstrated a significant improvement immediately after the intervention as compared to the CG. In the former group the program appears to have been quite successful initially, but the values could not be retained over a period of one year.
Especially among patients who tended to somatize their symptoms we noted an increase in fear avoidance behavior as well as a rapid return of VAS scores to near-baseline values after the intervention program. Thus, a refresher program and a repetition of behavioral therapy measures would be meaningful.
It would also be useful to administer such behavioral-therapy-oriented programs primarily to patients with marked fear avoidance behavior and/or additional psychological difficulties. Thus, when dealing with patients with chronic back pain, attention should be focused on psychosocial risk factors and the treatment should be modified accordingly. The contradictory statements reported in the published literature regarding the efficacy of fitness programs with or without behavior therapy, such as those mentioned in a review performed by van Middelkoop et al.,  may result in too little attention being given to the above mentioned factors at the start of the reported programs. Usually all patients are treated the same way, regardless of these factors. However, psychosocial factors such as catastrophizing, fear avoidance, somatization, depression and distress cause a two-fold increase in the risk of chronic back pain . As early as in the 1990’s it was found that fear avoidance behavior is probably the most important prognostic factor in the process of chronification, and that it would be quite meaningful to inform patients appropriately as early as possible [35-37].
Careful screening of patients, based on a biopsychosocial approach, would therefore be meaningful. For such an evaluation we have various types of high-quality screening instruments and questionnaires . However, we have achieved no international consensus which of the questionnaires should be used. This aspect could also be addressed in future research such as in the study protocol of O’Keeffe et al., .
Finally, we would like to point to the limitations of our study: All patients included in the study had been experiencing pain for a long time (on average about 7 years), which might be a possible reason for the poor sustained effect of the program. Participation in the program was voluntary. Persons who received written requests had to report to us by telephone. It may therefore be assumed that a large number of patients with pre-existing severe symptoms were interested in the program. Study dropouts had significantly less pain at time point 1 than those who remained in the study. This might be an indication of the fact that these patients rated the effort involved in the study too high in relation to their rather mild symptoms. The CG had a significantly higher VAS score (time frame of 7 days) at time point 1. A higher VAS in the IG possibly would have resulted in stronger differences in the results. After the first investigation the neck or back book was handed out to the CG as well. The back book has been found to exert a positive effect in patients with back pain . This would explain the response of the CG in terms of a reduction on the ODI at time point 2. However, we had expected the intervention program to significantly exceed the effect of the neck or back book alone. Members of the CG received less treatment because the program was not conducted here. But the patients of this group might have been additionally motivated by the investigation and the information they received and might have requested additional extern treatment. This could have been the reason for the observed improvement in the CG and may have reduced group differences as well. Possibly, in future studies one should give more attention to the evaluation of so-called “treatment as usual” . The exercises learned by the IG could be performed independently at home. However, the significant increase in the number of repetitions, the increase in training weights, and the change in execution does lead one to suspect that the participants performed an independent short-term exercise program at home, but we did not determine whether the exercises were performed after one year as well. Besides, in the case of the neck and spine book we did not check whether the instructions were actually read and followed by the study participants.
Furthermore, it was not possible to separate effects of exercise vs. behavioral therapy.
Future investigations will show whether more successful therapy options can be designed for patients with acute or subacute back pain while taking psychosocial factors into account when administering outpatient therapy programs, and whether chronic pain can thus be largely prevented. For patients with chronic back pain only intensive interdisciplinary programs with both in-patient and out-patient treatment modules can be helpful for long term view.
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Citation:Machacek P, Wepner M, Holzapfel J, Hahne J, Friedrich M (2015). The Long-Term Effect of an Outpatient Intervention Program with a Behavioral Therapy Approach in Patients with Chronic Back or Neck Pain with a Focus on Psychosocial Aspects. J Orthop Res Physiother 1: 014
Copyright: © 2015 Peter Machacek, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.