Manipulation Effects on Abdominal Muscles

This study is currently recruiting participants.
Verified March 2014 by University of Nevada, Las Vegas
Sponsor:
Information provided by (Responsible Party):
Emilio, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier:
NCT01745939
First received: December 5, 2012
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Low Back Pain
Other: Lumbar Manipulation
Other: Sham manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: The Immmediate Effects of Thrust Joint Manipulation on the Resting and Contraction Thickness of Transversus Abdominis in Subjects With Low Back Pain

Resource links provided by NLM:


Further study details as provided by University of Nevada, Las Vegas:

Primary Outcome Measures:
  • Transversus abdominis thickness change [ Time Frame: Baseline to immediately after the intervention (within 5 minutes) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Numeric Pain Rating Scale [ Time Frame: Baseline to immediately after the intervention (within 5 minutes) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lumbar manipulation
Patients will receive thrust joint manipulation to their lumbar spine in side lying
Other: Lumbar Manipulation
Manual therapy intervention
Sham Comparator: Sham manipulation
Patients will receive oscillations into slight rotation, without cavitation, in side lying
Other: Sham manipulation
Manual therapy intervention

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745939

Contacts
Contact: Emilio J Puentedura, PT, PhD 702-895-1621 louie.puentedura@unlv.edu

Locations
United States, Nevada
University of Nevada, Las Vegas - Department of Physical Therapy Recruiting
Las Vegas, Nevada, United States, 89154
Principal Investigator: Emilio J Puentedura, PT, PhD         
Sponsors and Collaborators
University of Nevada, Las Vegas
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
  More Information

No publications provided

Responsible Party: Emilio, Assistant Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT01745939     History of Changes
Other Study ID Numbers: UNLVPT-4056
Study First Received: December 5, 2012
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nevada, Las Vegas:
Back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014