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OpenTrials
Completed

NCT Number: NCT01933399

Comparison of Extensible and Inextensible Lumbosacral Orthoses for Lower Back Pain

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inextensible LSO (stiff back support)

Other

Cotton/nylon canvas back support with velcro fasteners.

Extensible LSO, a back support that is flexible

Other

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

Standard of care

Other

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

Primary outcomes

  1. Change Score in the Self-assessment of Disability as Measured by Oswestry Disability Index (ODI)

    Time frame: Baseline and 2 weeks

    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 outcomes

  1. Change Score in the Patient Specific Activity Scale

    Time frame: Baseline and 2-weeks

    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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Acronym: LSO LBP

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Sep 2, 2013
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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