Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Lumbar traction

• Registration Number: NCT03127410
• Lead Sponsor: Texas Woman's University

Brief Summary

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction

Detailed Description

The objective in this study is to determine the predictive validity of a set of special clinical tests in identifying those who will respond to lumbar traction. The central hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to identify a subgroup of patients with low back pain who will respond favorably to mechanical lumbar traction. If these clinical tests can identify a subgroup of patients with low back pain who respond favorably to lumbar traction, additional studies, including randomized clinical trials will be necessary to further test and validate the use of this cluster of clinical tests. The rationale for this research is to examine the connection between provocative lumbar compression testing and lumbar traction as a means of decompression

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-03-30
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-25
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-16
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Complaints of low back pain with or without pain into the lower extremities
• Pain of at least 2/10 according to the Numeric Pain Rating Scale
• Score of at least 20 or greater on the Oswestry Disability Index

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Exclusion Criteria

• Medical red flags consistent with non-mechanical back pain (i.e. recent weight loss, history of cancer, night sweats, fever)
• Previous surgery to the lumbar spine
• Current pregnancy
• Any neurological symptoms in the lower extremities
• Evidence of central nervous system involvement
• The inability to lie prone for 15 minutes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Traction	Lumbar traction	Intermittent lumbar traction will be performed in the prone position for 3 x 15-minute sessions at 40% of the participants body weight and will be adjusted based on the participants response.

Primary Outcome Measures

Name	Time	Method
Change in Disability	14 days	Modified Oswestry Disability Index

Secondary Outcome Measures

Name	Time	Method
Change in perceived outcome	14 days	Global Rating of Change
Change in Pain	14 days	Numeric Pain Rating Scale

Trial Locations

Locations (1)

Texas Woman's University-Dallas; 🇺🇸 Dallas, Texas, United States