N/A N=98 Randomized Single-blind Treatment

Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

Low Back Pain

Bottom Line

View on ClinicalTrials.gov: NCT01933399 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2015

Primary outcome: Primary: Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) — 2.4; 8.1; 14.0 units on a scale — p=.01

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Inextensible LSO (stiff back support) (Other); Extensible LSO, a back support that is flexible (Other); Standard of Care (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medical University of South Carolina
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)	2.4; 8.1; 14.0	.01 sig
SECONDARY Change Score in the Patient Specific Activity Scale	-0.4; -1.2; -1.8	0.01 sig

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).

Eligibility Criteria

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.

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Data sourced from ClinicalTrials.gov (NCT01933399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.