Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain (LSO LBP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Morrisette, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01933399
First received: June 24, 2013
Last updated: April 13, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention
Low Back Pain
Other: Inextensible LSO (stiff back support)
Other: Extensible LSO, a back support that is flexible
Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of Inextensible and Extensible Lumbosacral Orthoses for the Management of Episodes of Lower Back Pain

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI) [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change Score in the Patient Specific Activity Scale [ Time Frame: Baseline and 2-weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 98
Study Start Date: September 2007
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard of Care
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
Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
Experimental: Extensible lumbosacral orthoses plus standard of care
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
Back support is constructed from lycra and neoprene with velcro fasteners.
Experimental: 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.
Other: Inextensible LSO (stiff back support)
Cotton/nylon canvas back support with velcro fasteners.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933399

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: David Morrisette, PT, PhD Medical Unversity of South Carolina
  More Information

No publications provided

Responsible Party: David Morrisette, Professor and Director, Division of Physical Therapy, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01933399     History of Changes
Other Study ID Numbers: 16527
Study First Received: June 24, 2013
Results First Received: February 20, 2015
Last Updated: April 13, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Low back pain
Back brace
Lumbar orthoses
Lumbosacral orthoses
Low back pain treatment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on September 03, 2015