Clinical trial NCT01830751: Limiting Trunk Flexion as a Self-treatment for Low Back Pain
Official title: Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: self treatment technique
chronic
non specific
LBP
control trunk flexion
diurnal
Lead sponsor: Liberty Mutual Research Institute for Safety
Sponsor class: INDUSTRY
First posted: 2013-04-12
Enrollment: 106
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pain Score (numerical rating scale 0-10)
timeFrame: Baseline and 3 months (end of intervention phase)
Secondary outcomes:
measure: Functional limitation in work
timeFrame: Baseline and 3 months (end of intervention phase)
measure: Medication taken for back pain
timeFrame: Baseline and 3 months (end of intervention phase)
Other outcomes:
Locations:
city: Hopkinton
country: United States
facility: Liberty Mutual Research Institute for Safety
state: Massachusetts
Study officials:
affiliation: Liberty Mutual Research Institute for Safety
name: Raymond W McGorry, MS, PT
role: PRINCIPAL_INVESTIGATOR
References: