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

NCT ID: NCT01830751

Last Updated: 2018-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2018-03-01

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.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Limit trunk flexion upon rising

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

Group Type: EXPERIMENTAL

Restrained Sitting Treatment

Intervention Type: OTHER

Training in avoidance of trunk flexion, with the use of a tall backrest with lumbar support to which the participant straps themselves. Participants are taught to strap into the backrest while while seated in a chair, and with hips and knees bent at right angles, for one hour at the appointed time of day.

Limit trunk flexion before going to bed

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

Group Type: SHAM_COMPARATOR

Restrained Sitting Treatment

Intervention Type: OTHER

Training in avoidance of trunk flexion, with the use of a tall backrest with lumbar support to which the participant straps themselves. Participants are taught to strap into the backrest while while seated in a chair, and with hips and knees bent at right angles, for one hour at the appointed time of day.

Interventions

Restrained Sitting Treatment

Training in avoidance of trunk flexion, with the use of a tall backrest with lumbar support to which the participant straps themselves. Participants are taught to strap into the backrest while while seated in a chair, and with hips and knees bent at right angles, for one hour at the appointed time of day.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liberty Mutual Research Institute for Safety

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raymond W McGorry, MS, PT

Role: PRINCIPAL_INVESTIGATOR

Liberty Mutual Research Institute for Safety

Locations

Liberty Mutual Research Institute for Safety

Hopkinton, Massachusetts, United States

Countries

United States

Other Identifiers

LMRIS 12-02

Identifier Type: -

Identifier Source: org_study_id