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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127410
• Other study ID #: 19399
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: Texas Woman's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Lumbar traction
Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.

Locations

Country	Name	City	State
United States	Texas Woman's University-Dallas	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disability	Modified Oswestry Disability Index	14 days
Secondary	Change in Pain	Numeric Pain Rating Scale	14 days
Secondary	Change in perceived outcome	Global Rating of Change	14 days