Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

NCT01933399 | Completed Results

• 1 other identifier: 16527
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change Score in the Patient Specific Activity Scale

  Baseline and 2-weeks

Study Arms (3)

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.

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

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.

Other: Inextensible LSO (stiff back support)

Interventions

Inextensible LSO (stiff back support) OTHER

Cotton/nylon canvas back support with velcro fasteners.

Inextensible lumbosacral orthoses and standard of care

Extensible LSO, a back support that is flexible OTHER

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

Extensible lumbosacral orthoses plus standard of care

Standard of Care OTHER

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

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• chief complaint of lower back pain, with or without lower extremity (LE) symptoms
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: David Morrisette, PhD
• Organization: MUSC

morrisdc@musc.edu

843-792-2940

Study Officials

• David Morrisette, PT, PhD

  Medical Unversity of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director, Division of Physical Therapy

Study Record Dates

• First Submitted: June 24, 2013
• First Posted: September 2, 2013
• Study Start: September 1, 2007
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 30, 2015
• Results First Posted: April 30, 2015

Record last verified: 2015-04

Locations

US (1)