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Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

NCT ID: NCT01933399

Last Updated: 2015-04-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Low Back Pain

Keywords

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Low back pain Back brace Lumbar orthoses Lumbosacral orthoses Low back pain treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care

Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.

Group Type OTHER

Standard of Care

Intervention Type OTHER

Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.

Extensible lumbosacral orthoses plus standard of care

This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter

Group Type EXPERIMENTAL

Extensible LSO, a back support that is flexible

Intervention Type OTHER

Back support is constructed from lycra and neoprene with velcro fasteners.

Inextensible lumbosacral orthoses and standard of care

This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.

Group Type EXPERIMENTAL

Inextensible LSO (stiff back support)

Intervention Type OTHER

Cotton/nylon canvas back support with velcro fasteners.

Interventions

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Inextensible LSO (stiff back support)

Cotton/nylon canvas back support with velcro fasteners.

Intervention Type OTHER

Extensible LSO, a back support that is flexible

Back support is constructed from lycra and neoprene with velcro fasteners.

Intervention Type OTHER

Standard of Care

Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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David Morrisette

Professor and Director, Division of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Morrisette, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical Unversity of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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16527

Identifier Type: -

Identifier Source: org_study_id