Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain

Study Overview
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Brief Summary
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A randomized controlled trial for patients with chronic low back pain with two treatment arms and one waiting list control group. Primary outcome is pain intensity on VAS.

Official Title
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Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain - a Randomized Controlled Trial

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Manual Therapy/Exercises
* Behavioral: Physiotherapy/Back School


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pre-existing and specialist confirmed diagnosis of chronic low back pain for at least 3 months prior to inclusion Average pain intensity with at least 40 mm on the VAS from 0 to 100 mm and pain on at least 5 of 7 weekdays in the last 3 months. Exclusion criteria: Regular own exercise practice for the treatment of back pain (including yoga and other interventions) Invasive spinal procedures within the past 6 weeks or planned within the next 10 weeks Acute disc herniation (diagnosed within the last 3 months) Congenital deformities of the lumbar spine Rheumatoid arthritis Fibromyalgia Ankylosing spondylitis Severe comorbidities Pregnancy/lactation Current participation in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Therapy/Exercises<br>Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist. | Behavioral: Manual Therapy/Exercises<br>* Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.<br>|
| Experimental: Physiotherapy/Back School<br>Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist. | Behavioral: Physiotherapy/Back School<br>* Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.<br>|
| No Intervention: Waiting List<br>Study arm 3 consists of a waiting list control group, combined with the offer to participate in one of the above mentioned interventions after 6 months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in average pain intensity in previous week | Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline for back pain specific disability | Use of standardized Roland Morris Disability Questionnaire (RMDQ) to assess back pain specific disability. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | 3 months, 6 months | 
| Change from baseline in average pain intensity in previous week | Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100). | 6 months | 
| Change from baseline in pain bothersomeness in previous week | Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100). | 3 months, 6 months | 
| Change from baseline in pain medication use in the previous week | Specific self-reported pain medication use in previous week. | 3 months, 6 months | 
| Change from baseline for health related quality of life | Use of standardized Short Form 36 Health Survey (SF-36). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | 3 months, 6 months | 
| Change from baseline for pain self-efficacy | Use of standardized Pain Self-Efficacy Questionnaire (PSEQ). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | 3 months, 6 months | 
| Change from baseline for work productivity | Use standardized Work Productivity and Activity Impairment Questionnaire (WPAI) to assess employment status and productivity. The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | 3 months, 6 months | 
| Change from baseline for anxiety and depression | Use of standardized Hospital Anxiety and Depression Scale (HADS). The scale ranges from 0 to 100, where 0 is the lowest level and 100 is the highest level. | 3 months, 6 months |