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

Low Back Pain Clinical Trial

— RST  

Official title:

Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830751
• Other study ID #: LMRIS 12-02
• Status: Completed
• Phase: N/A
• First received: March 29, 2013
• Last updated: March 7, 2018
• Start date: March 2013
• Est. completion date: March 1, 2018

Study information

• Verified date: March 2018
• Source: Liberty Mutual Research Institute for Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: March 1, 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Liberty Mutual Research Institute for Safety	Hopkinton	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Liberty Mutual Research Institute for Safety

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Score (numerical rating scale 0-10)	Change in mean number of days reporting disability from beginning to end of intervention phase	Baseline and 3 months (end of intervention phase)
Secondary	Functional limitation in work	Change in mean number of days reporting disability from beginning to end of intervention phase	Baseline and 3 months (end of intervention phase)
Secondary	Medication taken for back pain	Change in mean number of days reporting medication use from beginning to end of intervention phase	Baseline and 3 months (end of intervention phase)