Low Back PainLSO LBPNCT01933399
Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain
A study testing Inextensible LSO (stiff back support) and Extensible LSO, a back support that is flexible in people with Low Back Pain, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Inextensible LSO (stiff back support) and Extensible LSO, a back support that is flexible
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chief complaint of lower back pain, with or without lower extremity (LE) symptoms
- 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics
Who cannot join
- previous spinal surgery
- workman's compensation or litigation is involved
- neurological disease or injury
- systemic inflammatory disease
- pulmonary disease which restricts breathing capacity
- current pregnancy
Show all 12Show fewer
- acute fracture
- tumor or metastatic disease
- infection
- neurological disease
- the presence of pathological reflexes (e.g., Babinski)
- the presence of lower extremity pain upon cervical motion and / or the presence of two or more of the following signs of nerve compression: diminished lower extremity strength in a myotomal distribution, diminished sensation, and / or absence deep tendon reflexes.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain
This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).
- Conditions
- Low Back Pain
- Being tested
- Inextensible LSO (stiff back support), Extensible LSO, a back support that is flexible, Standard of Care
- Keywords
- Low back pain, Back brace, Lumbar orthoses, Lumbosacral orthoses, Low back pain treatment
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inextensible LSO (stiff back support)Other
Cotton/nylon canvas back support with velcro fasteners.
Extensible LSO, a back support that is flexibleOther
Back support is constructed from lycra and neoprene with velcro fasteners.
Standard of CareOther
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Other | Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. Receives: Other: Standard of Care |
| Extensible lumbosacral orthoses plus standard of care | Experimental | This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter Receives: Other: Extensible LSO, a back support that is flexible |
| Inextensible lumbosacral orthoses and standard of care | Experimental | This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions. Receives: Other: Inextensible LSO (stiff back support) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)
Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.
Measured: Baseline and 2 weeks
Secondary outcomes (1)
Change Score in the Patient Specific Activity Scale
Change score from baseline and the score at the second week. Compare score change to the minimal clinically important difference and analyze for statistical significance between the baseline and the 2nd week score, and the statistical difference in the change scores across the 3 groups. Scores from 0 to 10 with a higher score representing higher function and a lower score representing a decrease function.
Measured: Baseline and 2-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startSep 2007
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Morrisette, Medical University of South Carolina
- Investigators
- David Morrisette, PT, PhD, Principal investigator, Medical Unversity of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933399
- Sponsor's protocol ID
- 16527
- Acronym
- LSO LBP
- Status last verified
- Apr 2015
- First submitted
- 24 Jun 2013
- Last updated
- 30 Apr 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain
- ClinicalTrials.gov ID
- NCT01933399
- Acronym / sponsor ID
- LSO LBP / 16527
- Conditions
- Low Back Pain
- Keywords
- Low back pain, Back brace, Lumbar orthoses, Lumbosacral orthoses, Low back pain treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Posted 30 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to discern if the use of a lumbosacral orthesis (LSO, also call a back support) improves the short-term outcome of lower back pain. participants will receive standard care (physical therapy, physician treatment), with one group also receiving an extensible LSO, and another group receiving an inextensible LSO. The inextensible LSO has been shown to increase stiffness of the trunk in individuals while wearing it. The hypothesis is that the group wearing the inextensible LSO will have improved outcomes over the other two groups (standard care or standard care plus the extensible LSO).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | Other | Other: Standard of CareMedication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks. |
| Extensible lumbosacral orthoses plus standard of care | Experimental | Other: Extensible LSO, a back support that is flexibleThis group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter |
| Inextensible lumbosacral orthoses and standard of care | Experimental | Other: Inextensible LSO (stiff back support)This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chief complaint of lower back pain, with or without lower extremity (LE) symptoms
- 150 subjects will be recruited from patients seeking treatment for lower back pain from spine specialty orthopaedic clinics, family practice physicians, and out-patient physical therapy clinics
Key exclusion criteria (12 listed)
- previous spinal surgery
- workman's compensation or litigation is involved
- neurological disease or injury
- systemic inflammatory disease
- pulmonary disease which restricts breathing capacity
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 |
|---|---|---|
| Inextensible LSO (stiff back support)Cotton/nylon canvas back support with velcro fasteners. | Other | Inextensible lumbosacral orthoses and standard of care |
| Extensible LSO, a back support that is flexibleBack support is constructed from lycra and neoprene with velcro fasteners. | Other | Extensible lumbosacral orthoses plus standard of care |
| Standard of CarePhysician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy. | Other | Standard of Care |
Primary outcome
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)
Time frame: Baseline and 2 weeks
Change score from baseline and the score at the second week. The Oswestry Disabilty Index is a 100 point self-assessment of disabilty due to lower back pain or complications from lower back pain. A score of 40 or more points is interpreted as signficant disability due to lower back pain. A score between 20 and 40 respresents disability, but the individual is still able to function to some degree with activities of daily living, but has to modify their behavior. A score less than 20 implies that the disabilty due to the lower back pain is not greatly impacting a wide range of functions. Compare score change to the minimal clinically important difference between the baseline and the 2nd week score, and the difference in the change scores across the 3 groups.
1 secondary outcome
Change Score in the Patient Specific Activity Scale
Time frame: Baseline and 2-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
David Morrisette, PT, PhD principal investigator
Medical Unversity of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inextensible LSO (stiff back support) and Extensible LSO, a back support that is flexible in people with Low Back Pain, run by Medical University of South Carolina 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 2 inclusion and 12 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 30 Apr 2015. 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. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) (time frame: Baseline and 2 weeks). 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 30 Apr 2015.