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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumbar traction
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Texas Woman's University-Dallas

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Traction

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in Disability
Modified Oswestry Disability Index

Secondary Outcome Measures

Change in Pain
Numeric Pain Rating Scale
Change in perceived outcome
Global Rating of Change

Full Information

First Posted
March 30, 2017
Last Updated
September 16, 2019
Sponsor
Texas Woman's University
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1. Study Identification

Unique Protocol Identification Number
NCT03127410
Brief Title
Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study
Official Title
Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Investigator is blinded to intervention
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traction
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Lumbar traction
Intervention Description
Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.
Primary Outcome Measure Information:
Title
Change in Disability
Description
Modified Oswestry Disability Index
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Change in Pain
Description
Numeric Pain Rating Scale
Time Frame
14 days
Title
Change in perceived outcome
Description
Global Rating of Change
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Texas Woman's University-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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