Manual Therapy/Exercises vs. Physiotherapy/Back School vs. Waiting List in Patients With Chronic Low Back Pain
- Conditions
- Chronic Low-back Pain
- Interventions
- Behavioral: Manual Therapy/ExercisesBehavioral: Physiotherapy/Back School
- Registration Number
- NCT05843149
- Lead Sponsor
- Charite University, Berlin, Germany
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Manual Therapy/Exercises 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. Physiotherapy/Back School 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.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 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 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 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 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.
Trial Locations
- Locations (1)
Charite University
🇩🇪Berlin, Germany