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

Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific 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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Restrained Sitting Treatment

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Hopkinton, Massachusetts, United States, 01748
      • Liberty Mutual Research Institute for Safety

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Limit trunk flexion upon rising; Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour.	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.
Sham Comparator: Limit trunk flexion before going to bed; Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Liberty Mutual Research Institute for Safety
• Investigators: Principal Investigator: Raymond W McGorry, MS, PT, Liberty Mutual Research Institute for Safety

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: March 29, 2013
• First Submitted That Met QC Criteria: April 9, 2013
• First Posted (Estimate): April 12, 2013

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: chronic; LBP; diurnal; self treatment technique; non specific; control trunk flexion
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: LMRIS 12-02