CClinicalTrials.gg
CompletedNCT03127410Updated Sep 19, 2019

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

An interventional study of Lumbar traction in Low Back Pain, sponsored by Texas Woman's University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-09-19.

Sponsored by Texas Woman's University · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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

Read the 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

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Conditions studied

  • Low Back Pain

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03

In context

Low Back Pain

2,818 studies on the registry are indexed under Low Back Pain; 482 are open to participants now.

This study's enrollment of 40 is below the median of 60 across 2,268 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Texas Woman's University is the lead sponsor of 82 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • OtherLumbar traction

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

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What researchers measure

Primary outcomes

  1. Change in Disability

    Modified Oswestry Disability Index

    Time frame: 14 days

Secondary outcomes

  1. Change in Pain

    Numeric Pain Rating Scale

    Time frame: 14 days

  2. Change in perceived outcome

    Global Rating of Change

    Time frame: 14 days

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Study locations

1 site
  • Texas Woman's University-Dallas
    Dallas, Texas 75235, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03127410
Lead sponsor
Texas Woman's University
Responsible party
Kelli Brizzolara (Assistant Professor, Texas Woman's University) — Principal investigator
First posted
Apr 25, 2017
Start date
Mar 30, 2017
Primary completion
Dec 31, 2018
Completion
Dec 31, 2018
Last update
Sep 19, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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