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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restrained Sitting Treatment
Sponsored by
Liberty Mutual Research Institute for Safety
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring self treatment technique, chronic, non specific, LBP, control trunk flexion, diurnal

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Liberty Mutual Research Institute for Safety

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Limit trunk flexion upon rising

Limit trunk flexion before going to bed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain Score (numerical rating scale 0-10)
Change in mean number of days reporting disability from beginning to end of intervention phase

Secondary Outcome Measures

Functional limitation in work
Change in mean number of days reporting disability from beginning to 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

Full Information

First Posted
March 29, 2013
Last Updated
March 7, 2018
Sponsor
Liberty Mutual Research Institute for Safety
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1. Study Identification

Unique Protocol Identification Number
NCT01830751
Brief Title
Limiting Trunk Flexion as a Self-treatment for Low Back Pain
Acronym
RST
Official Title
Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liberty Mutual Research Institute for Safety

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
self treatment technique, chronic, non specific, LBP, control trunk flexion, diurnal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Limit trunk flexion upon rising
Arm Type
Experimental
Arm Description
Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour.
Arm Title
Limit trunk flexion before going to bed
Arm Type
Sham Comparator
Arm Description
Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour.
Intervention Type
Other
Intervention Name(s)
Restrained Sitting Treatment
Intervention Description
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 Outcome Measure Information:
Title
Pain Score (numerical rating scale 0-10)
Description
Change in mean number of days reporting disability from beginning to end of intervention phase
Time Frame
Baseline and 3 months (end of intervention phase)
Secondary Outcome Measure Information:
Title
Functional limitation in work
Description
Change in mean number of days reporting disability from beginning to end of intervention phase
Time Frame
Baseline and 3 months (end of intervention phase)
Title
Medication taken for back pain
Description
Change in mean number of days reporting medication use from beginning to end of intervention phase
Time Frame
Baseline and 3 months (end of intervention phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond W McGorry, MS, PT
Organizational Affiliation
Liberty Mutual Research Institute for Safety
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liberty Mutual Research Institute for Safety
City
Hopkinton
State/Province
Massachusetts
ZIP/Postal Code
01748
Country
United States

12. IPD Sharing Statement

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

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