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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01830751
Acronym
RST
Enrollment
106
Registered
2013-04-12
Start date
2013-03-31
Completion date
2018-03-01
Last updated
2018-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

self treatment technique, chronic, non specific, LBP, control trunk flexion, diurnal

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.

Interventions

OTHERRestrained 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.

Sponsors

Liberty Mutual Research Institute for Safety
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
30 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain Score (numerical rating scale 0-10)Baseline and 3 months (end of intervention phase)Change in mean number of days reporting disability from beginning to end of intervention phase

Secondary

MeasureTime frameDescription
Functional limitation in workBaseline and 3 months (end of intervention phase)Change in mean number of days reporting disability from beginning to end of intervention phase
Medication taken for back painBaseline and 3 months (end of intervention phase)Change in mean number of days reporting medication use from beginning to end of intervention phase

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026