Low Back PainRSTNCT01830751
Limiting Trunk Flexion as a Self-treatment for Low Back Pain
A study testing Restrained Sitting Treatment in people with Low Back Pain, run by Liberty Mutual Research Institute for Safety at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Restrained Sitting Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to 1 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Liberty Mutual Research Institute for Safety
Hopkinton, Massachusetts, 01748
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Restrained Sitting Treatment
- Keywords
- self treatment technique, chronic, non specific, LBP, control trunk flexion, diurnal
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restrained Sitting TreatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Limit trunk flexion upon rising | Experimental | Immediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour. Receives: Other: Restrained Sitting Treatment |
| Limit trunk flexion before going to bed | Sham comparator | Immediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour. Receives: Other: Restrained Sitting Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (numerical rating scale 0-10)
Change in mean number of days reporting disability from beginning to end of intervention phase
Measured: Baseline and 3 months (end of intervention phase)
Secondary outcomes (2)
Functional limitation in work
Change in mean number of days reporting disability from beginning to end of intervention phase
Measured: 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
Measured: Baseline and 3 months (end of intervention phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberty Mutual Research Institute for Safety
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Raymond W McGorry, MS, PT, Principal investigator, Liberty Mutual Research Institute for Safety
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830751
- Sponsor's protocol ID
- LMRIS 12-02
- Acronym
- RST
- Status last verified
- Mar 2018
- First submitted
- 29 Mar 2013
- Last updated
- 8 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influencing Diurnal Variation in Disc Hydration as a Treatment for Non-specific Low Back Pain
- ClinicalTrials.gov ID
- NCT01830751
- Acronym / sponsor ID
- RST / LMRIS 12-02
- Conditions
- Low Back Pain
- Keywords
- self treatment technique, chronic, non specific, LBP, control trunk flexion, diurnal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Liberty Mutual Research Institute for SafetyIndustry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Limit trunk flexion upon rising | Experimental | Other: Restrained Sitting TreatmentImmediately upon rising particpants perform the Restrained Sitting Treatment intervention for one hour. |
| Limit trunk flexion before going to bed | Sham comparator | Other: Restrained Sitting TreatmentImmediately prior to going to bed, particpants perform the Restrained Sitting Treatment intervention for one hour. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restrained Sitting TreatmentTraining 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. | Other | Limit trunk flexion before going to bed, Limit trunk flexion upon rising |
Primary outcome
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
2 secondary outcomes
Functional limitation in work
Time frame: Baseline and 3 months (end of intervention phase)
Medication taken for back pain
Time frame: Baseline and 3 months (end of intervention phase)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond W McGorry, MS, PT principal investigator
Liberty Mutual Research Institute for Safety
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restrained Sitting Treatment in people with Low Back Pain, run by Liberty Mutual Research Institute for Safety at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (numerical rating scale 0-10) (time frame: Baseline and 3 months (end of intervention phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2018.