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

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ClinicalTrials.gov Identifier: NCT01830751
Recruitment Status : Completed
First Posted : April 12, 2013
Last Update Posted : March 8, 2018
Sponsor:
Information provided by (Responsible Party):
Liberty Mutual Research Institute for Safety

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Restrained Sitting Treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain
Actual Study Start Date : March 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : March 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01830751


Locations
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United States, Massachusetts
Liberty Mutual Research Institute for Safety
Hopkinton, Massachusetts, United States, 01748
Sponsors and Collaborators
Liberty Mutual Research Institute for Safety
Investigators
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Principal Investigator: Raymond W McGorry, MS, PT Liberty Mutual Research Institute for Safety

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Responsible Party: Liberty Mutual Research Institute for Safety
ClinicalTrials.gov Identifier: NCT01830751     History of Changes
Other Study ID Numbers: LMRIS 12-02
First Posted: April 12, 2013    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018

Keywords provided by Liberty Mutual Research Institute for Safety:
self treatment technique
chronic
non specific
LBP
control trunk flexion
diurnal

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms