Chronic Low-back Pain
Conditions
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.
Interventions
BEHAVIORALManual Therapy/Exercises
Three individual therapy sessions and nine group sessions manual therapy/exercises of 60 min. duration under the guidance of a trained therapist.
BEHAVIORALPhysiotherapy/Back School
Three individual therapy sessions and nine group sessions physiotherapy/back school of 60 min. duration under the guidance of a trained therapist.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Treatment adherence (class/session attendance) | 3 months, 6 months | Assess treatment adherence according to attendance during 12 week intervention period. |
| 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. |
Countries
Germany
Outcome results
None listed