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

Sponsor

Texas Woman's University (Other)

Overall Status

Completed

CT.gov ID

NCT03127410

Collaborator

(none)

Enrollment

Location

Arm

21.1

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Lumbar traction	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Masking Description:

Investigator is blinded to intervention

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Mar 30, 2017

Actual Primary Completion Date :

Dec 31, 2018

Actual Study Completion Date :

Dec 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: Lumbar traction Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.

Arm

Intervention/Treatment

Experimental: 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.

Other: Lumbar traction

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

Outcome Measures

Primary Outcome Measures

Change in Disability [14 days]
Modified Oswestry Disability Index

Secondary Outcome Measures

Change in Pain [14 days]
Numeric Pain Rating Scale
Change in perceived outcome [14 days]
Global Rating of Change

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Texas Woman's University-Dallas	Dallas	Texas	United States	75235

Sponsors and Collaborators

Texas Woman's University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kelli Brizzolara, Assistant Professor, Texas Woman's University

ClinicalTrials.gov Identifier:

NCT03127410

Other Study ID Numbers:

19399

First Posted:

Apr 25, 2017

Last Update Posted:

Sep 19, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Low Back Pain

Study Results

No Results Posted as of Sep 19, 2019