Skip to main content
OpenTrials
Completed

NCT Number: NCT01830751

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liberty Mutual Research Institute for Safety

Hopkinton, Massachusetts, 01748, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Restrained Sitting Treatment

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.

Primary outcomes

  1. Pain Score (numerical rating scale 0-10)

    Time frame: Baseline and 3 months (end of intervention phase)

    Change in mean number of days reporting disability from beginning to end of intervention phase

Secondary outcomes

  1. Functional limitation in work

    Time frame: Baseline and 3 months (end of intervention phase)

    Change in mean number of days reporting disability from beginning to end of intervention phase

  2. Medication taken for back pain

    Time frame: Baseline and 3 months (end of intervention phase)

    Change in mean number of days reporting medication use from beginning to end of intervention phase

Sponsors and collaborators

Lead sponsor

Liberty Mutual Research Institute for Safety

Industry

Registry information

Official study title

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

Acronym: RST

Important dates

Study start
2013
Primary completion
2016
Study completion
2018
First posted
Apr 12, 2013
Registry last updated
Mar 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.