Limiting Trunk Flexion as a Self-treatment for Low Back Pain
- Conditions
- Low Back Pain
- Interventions
- Other: Restrained Sitting Treatment
- Registration Number
- NCT01830751
- Lead Sponsor
- Liberty Mutual Research Institute for Safety
- Brief Summary
The purpose of the proposed study is to test the effect of an intervention technique that reduces trunk flexion upon rising, on the outcome measures of self-reported back pain and functional impairment in individuals with chronic or recurrent non-specific low back pain (LBP). The intervention is a self-administered and requires no medical intervention or drugs. The technique referred to as the restrained sitting treatment (RST), involves training in minimizing forward bending of the trunk immediately upon rising. The technique builds upon a previous randomized controlled study conducted and published by members of the research team. The underlying premise of RST exploits the natural diurnal pattern as the intervertebral discs (people are tallest when they first wake up). The discs are fully hydrated upon rising, disc internal hydrostatic pressures and external forces acting on surrounding soft tissues are greatest at this time, and these pressures and forces can increase significantly with trunk flexion. The RST technique utilizes a back support used in sitting during the first hour upon rising to minimize trunk flexion during this critical period as the intervertebral discs begins the diurnal cycle of fluid loss. The study will test the null hypothesis that there are no significant difference in outcome (LBP, work or social function/disability) between groups performing RST, the experimental group performing RST upon rising, the control group performing prior to going to bed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- Clinical diagnosis of chronic or recurrent low back pain
- Six month or longer history of non-specific LBP
- Minimum 90 days in pain in the last six months
- Average pain score of past month ≥3 on a 0-10 numerical rating scale
- Red flags (tumor, metabolic diseases, Rheumatoid arthritis, osteoporosis, prolonged steroid use, pregnancy, back surgery)
- Evidence of nerve root compression (pain reproduction with SLR>45º, weakness of major lower extremity muscle group, decreased deep tendon reflexes at knee or ankle, decreased sensation to pinprick)
- Acute trauma to low back
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Limit trunk flexion before going to bed Restrained Sitting Treatment Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour. Limit trunk flexion upon rising Restrained Sitting Treatment Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour.
- Primary Outcome Measures
Name Time Method Pain Score (numerical rating scale 0-10) Baseline and 3 months (end of intervention phase) Change in mean number of days reporting disability from beginning to end of intervention phase
- Secondary Outcome Measures
Name Time Method Functional limitation in work Baseline and 3 months (end of intervention phase) Change in mean number of days reporting disability from beginning to end of intervention phase
Medication taken for back pain Baseline and 3 months (end of intervention phase) Change in mean number of days reporting medication use from beginning to end of intervention phase
Trial Locations
- Locations (1)
Liberty Mutual Research Institute for Safety
🇺🇸Hopkinton, Massachusetts, United States