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

September 16, 2019 updated by: Kelli Brizzolara, Texas Woman's University
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • Texas Woman's University-Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Disability
Time Frame: 14 days
Modified Oswestry Disability Index
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: 14 days
Numeric Pain Rating Scale
14 days
Change in perceived outcome
Time Frame: 14 days
Global Rating of Change
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Texas Woman's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2017

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

March 30, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19399

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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