Manipulation Effects on Abdominal Muscles

November 3, 2014 updated by: Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas

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

The purpose of this study is to understand how different physical therapy interventions affect the use of certain abdominal muscles in patients with low back pain.

Study Overview

Status

Completed

Conditions

Detailed Description

Patients with low back pain will undergo ultrasound imaging of the lateral abdominal wall to measure resting and contracted thickness of the transversus abdominis muscle. Following the pre-intervention measurement, patients will receive one of two physical therapy interventions (side lying thrust joint manipulation or side lying non-thrust oscillations into slight rotation) which will have been randomly assigned. Immediately after intervention, ultrasound imaging will be repeated on the resting and contracted thickness of the transversus abdominis.

Study Type

Interventional

Enrollment (Actual)

12

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

    • Nevada
      • Las Vegas, Nevada, United States, 89154
        • University of Nevada, Las Vegas - Department of Physical Therapy

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:

  • Currently receiving physical therapy treatment for back pain or back pain symptoms
  • 18-70 years of age
  • Able to perform the abdominal drawing in maneuver

Exclusion Criteria:

  • Presence of a 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, or ankylosing spondylitis

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lumbar manipulation
Patients will receive thrust joint manipulation to their lumbar spine in side lying
Manual therapy intervention
Sham Comparator: Sham manipulation
Patients will receive oscillations into slight rotation, without cavitation, in side lying
Manual therapy intervention

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 term follow up.
Baseline to immediately after the intervention (within 5 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: Baseline to immediately after the intervention (within 5 minutes)
Rating of perceived pain 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 term follow up.
Baseline to immediately after the intervention (within 5 minutes)

Collaborators and Investigators

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

Investigators

  • Study Director: Jaclyn Durant, BSc, University of Nevada, Las Vegas
  • Study Director: Jade Elkind, BA, University of Nevada, Las Vegas
  • Study Director: Shawna Bohnet, BSc, University of Nevada, Las Vegas

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

November 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 5, 2012

First Submitted That Met QC Criteria

December 7, 2012

First Posted (Estimate)

December 10, 2012

Study Record Updates

Last Update Posted (Estimate)

November 5, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNLVPT-4056

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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