NCT03127410

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

March 30, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

1.8 years

First QC Date

March 30, 2017

Last Update Submit

September 16, 2019

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Change in Disability

    Modified Oswestry Disability Index

    14 days

Secondary Outcomes (2)

  • Change in Pain

    14 days

  • Change in perceived outcome

    14 days

Study Arms (1)

Traction

EXPERIMENTAL

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

Lumbar tractionOTHER

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

Traction

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Woman's University-Dallas

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Investigator is blinded to intervention
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 25, 2017

Study Start

March 30, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)