Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Manual Therapy/Exercises 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
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
|
| Experimental: Physiotherapy/Back School 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
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
|
| No Intervention: Waiting List 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. |
Outcome Measures
Primary Outcome Measures
- Change from baseline in average pain intensity in previous week [3 months]
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
Secondary Outcome Measures
- Change from baseline for back pain specific disability [3 months, 6 months]
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.
- Change from baseline in average pain intensity in previous week [6 months]
Intensity of pain in previous week as measured on a 100 mm visual analog scale (0-100).
- Change from baseline in pain bothersomeness in previous week [3 months, 6 months]
Bothersomeness in previous week as measured on a 100 mm visual analog scale (0-100).
- Change from baseline in pain medication use in the previous week [3 months, 6 months]
Specific self-reported pain medication use in previous week.
- Change from baseline for health related quality of life [3 months, 6 months]
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.
- Change from baseline for pain self-efficacy [3 months, 6 months]
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.
- Change from baseline for work productivity [3 months, 6 months]
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.
- Change from baseline for anxiety and depression [3 months, 6 months]
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.
Other Outcome Measures
- Number of participants with adverse events as a measure of safety and treatment adherence [3 months, 6 months]
Identify and assess self reported and unanticipated adverse events over the course of the study as a measure of safety and treatment adherence.
- Treatment adherence (class/session attendance) [3 months, 6 months]
Assess treatment adherence according to attendance during 12 week intervention period.
- App via mobile phones [3 times daily within baseline and 6 months]
Use of an mobile app to assess back pain intensity, pain medication, practice time
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Charite University | Berlin | Germany | 14109 |
Sponsors and Collaborators
- Charite University, Berlin, Germany
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NHKManual