The Effects of Thrust Joint Manipulation on the Resting and Contracting Thickness of Transversus Abdominis in Subjects With Low Back Pain

April 10, 2016 updated by: Kelly Fosberg, Nova Southeastern University
The primary aim of this study is to examine how different physical therapy interventions affect the resting state and contraction state of a certain abdominal muscle in patients with low back pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients with low back pain (LBP) will undergo ultrasound imaging of the transversus abdominis to measure the muscle thickness at rest and at the contracted state prior to intervention and again immediately after intervention. In this randomized controlled trial, patients will be randomized into one of two groups. One group will receive the intervention of thrust joint manipulation of the lumbar spine and the other group will receive the intervention of non-thrust joint manipulation of the lumbar spine.

Study Type

Interventional

Enrollment (Actual)

67

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
    • Arizona
      • Flagstaff, Arizona, United States, 86001
        • DeRosa Physical Therapy
    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada, Las Vegas

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults between 18-70 years of age with primary symptom of LBP, with or without referral into lower extremity.
  • Subjects must be able to read and write in English.

Exclusion Criteria:

  • Presence of serious pathology.
  • Diagnosis of spinal stenosis or symptoms in both lower legs (changes in sensation, muscle weakness).
  • Any history of low back surgery, rheumatoid arthritis, osteoporosis, osteopenia, scoliosis, or ankylosing spondylitis.
  • Pregnancy
  • Pending legal action.
  • Prior surgery to the lumbar spine or fractures of the lumbar spine.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Thrust Joint Manipulation
Patients will receive thrust joint manipulation to their lumbar spine in side lying.
Other: Thrust Joint Manipulation of the Lumbar Spine
Sham Comparator: Non-thrust Joint Manipulation
Patients will receive non-thrust joint manipulation, oscillations into slight rotation, without cavitation, to their lumbar spine in side lying.
Other: Non-thrust Joint Manipulation of the Lumbar Spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transversus Abdominis thickness change.
Time Frame: Baseline to immediately after the intervention (within 5 minutes).
Measurement of change in thickness from resting to contraction will be compared at baseline (pre-intervention) to immediately following the intervention (post-intervention). The study is looking at the immediate effects so there is no short-term or longer follow up.
Baseline to immediately after the intervention (within 5 minutes).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oswestry Low Back Pain Questionnaire
Time Frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
The score of the Oswestry Low Back Pain Questionnaire will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Numeric Pain Rating Scale
Time Frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
The score of the Numeric Pain Rating Scale will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Fear-Avoidance Beliefs Questionnaire
Time Frame: Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
The score of the Fear-Avoidance Beliefs Questionnaire will be compared from baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Baseline, immediately post-intervention (within 5 minutes), and follow-up within 48 hours over the phone.
Global Rating of Change
Time Frame: Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.
The score of the Global Rating of Change will be compared from immediately post-intervention (within 5 minutes) and follow-up within 48 hours over the phone.
Immediately post-intervention (within 5 minutes) and at follow-up within 48 hours over the phone.

Collaborators and Investigators

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

Sponsor

Nova Southeastern University

Collaborators

University of Nevada, Las Vegas
DeRosa Physical Therapy

Investigators

  • Principal Investigator: Kelly K Fosberg, DPT, Nova Southeastern University and DeRosa Physical Therapy
  • Study Chair: Joshua Cleland, PhD, Nova Southeastern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Estimate)

April 12, 2016

Last Update Submitted That Met QC Criteria

April 10, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01151512

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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