Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

Low Back Pain Clinical Trial

— LSO LBP  

Official title:

Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01933399
• Other study ID #: 16527
• Status: Completed
• Phase: N/A
• First received: June 24, 2013
• Last updated: April 13, 2015
• Start date: September 2007
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Exclusion criteria are:

• 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

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Inextensible LSO (stiff back support)
Cotton/nylon canvas back support with velcro fasteners.
• Extensible LSO, a back support that is flexible
Back support is constructed from lycra and neoprene with velcro fasteners.
• Standard of Care
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 2 weeks	No
Secondary	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.	Baseline and 2-weeks	No