Effect of an Outpatient Intervention Program in Patients With Chronic Back or Neck Pain

Study Overview
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Brief Summary
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To investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on chronic unspecific back or neck pain. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed.

Detailed Description
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BACKGROUND: Sustained success of ambulant intervention programs consisting of individual and group physiotherapy in patients with with chronic unspecific back or neck pain (cBP) has not been conclusively proven. It's still not clear whether one can achieve such success by devoting greater attention to psychosocial factors. OBJECTIVE: We investigated whether an ambulant intervention program with a behavioral therapy approach would exert a long-term effect on cBP. Specifically, the effect on patients with pronounced fear avoidance behavior and/or with psychosocial limitations was addressed. DESIGN: Prospective, randomized controlled trial SETTINGS, INTERVENTION: 64 patients were assigned to intervention group (IG) and 57 to control group (CG). All were examined, informed about cBP, and were encouraged to stay active and perform exercises according to specific instructions provided in a neck- or back-book. The IG received 9 units of physiotherapy and 2 units of occupational therapy, conducted with a behavioral therapy approach. Efficacy of treatment was evaluated after 6 and 58 weeks. MEASUREMENTS: Pain (VAS), quantity of painkillers consumed, sick leave days, Oswestry-Disability-Index (ODI), SF-36, FABQ.

Official Title
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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

Conditions
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Chronic Low Back Pain, Neck Pain

Intervention / Treatment
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* Behavioral: Physiotherapy and occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: minimum age 18 years, maximum age: men 55 years, women 50 years. the patients had been on sick leave for a minimum of 4 and a maximum of 22 days during the preceding 12 months because of nonspecific spinal symptoms in the back or neck. The patients had to be working at the start of the study. Exclusion Criteria: Specific causes of spinal symptoms (after spinal surgery, known vertebral body fractures, disk prolapse with motor deficits or other radicular lesions, tumor, osteomyelitis, spondylodiscitis, rheumatic disease, osteoporosis). Retired persons, those in the process of being screened for retirement, unemployed persons, pregnancy or persons on maternity leave Planned surgery during the phase of intervention persons who were unable to participate in the intervention program for other reasons (physical, psychological, linguistic or organizational).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training group<br>Physiotherapy and occupational therapy: Training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. | Behavioral: Physiotherapy and occupational therapy<br>* Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.<br>|
| No Intervention: Control Group<br>Members of the control group were referred to their general practitioner or specialist for further care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | 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) | After 0 / 6 / 58 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Social function, psychological wellbeing and emotional role function | To evaluate social function, psychological wellbeing and emotional role function we used the 36-item short form health survey (SF-36; scales 0-100, lower scores indicate poorer social, psychological and emotional quality of life) | After 0 / 6 / 58 weeks | 
| Functional impairment | The Oswestry disability index was used to measure functional impairment. | After 0 / 6 / 58 weeks | 
| Anxiety, insecurity in social contacts and compulsiveness | Anxiety, insecurity in social contacts and compulsiveness were registered on the brief symptoms inventory (BSI), which is an abridged version of SCL-90_R. The BSI addresses subjective experience of impairment based on a list of symptoms that are partly physical and partly psychological. The time frame is seven days. | After 0 / 6 / 58 weeks | 
| Sick leave days | The number of (self-reported) days of sick leave due to pain during the preceding twelve months were inquired. | After 0 / 58 weeks | 
| Painkillers | The number of painkillers taken per day were inquired. | After 0 / 58 weeks | 
| Fear avoidance behavior | Fear avoidance behavior was determined by means of the fear avoidance beliefs questionnaire (FABQ; scale 0-66; lower scores indicate lower fear-avoidance beliefs) | After 0 / 6 / 58 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outpatient intervention program, behavioral therapy approach, unspecific back pain, unspecific neck pain, chronic pain, physiotherapy, occupational therapy, psychosocial aspects, fear avoidance beliefs, health-related quality of life