Limiting Trunk Flexion as a Self-treatment for Low Back Pain (RST)

Liberty Mutual

Status: Completed

Conditions: Low Back Pain

Treatments: Other: Restrained Sitting Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01830751

LMRIS 12-02

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 30 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups

Limit trunk flexion upon rising

Experimental group

Description:

Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour.

Treatment:

Other: Restrained Sitting Treatment

Limit trunk flexion before going to bed

Sham Comparator group

Description:

Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour.

Treatment:

Other: Restrained Sitting Treatment