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Manipulation Effects on Abdominal Muscles

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745939
First Posted: December 10, 2012
Last Update Posted: November 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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 Emilio J Puentedura, PT, DPT, PhD, University of Nevada, Las Vegas:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: November 2012
Study Completion Date: August 2014
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01745939


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

Responsible Party: Emilio J Puentedura, PT, DPT, PhD, Assistant Professor, University of Nevada, Las Vegas
ClinicalTrials.gov Identifier: NCT01745939     History of Changes
Other Study ID Numbers: UNLVPT-4056
First Submitted: December 5, 2012
First Posted: December 10, 2012
Last Update Posted: November 5, 2014
Last Verified: November 2014

Keywords provided by Emilio J Puentedura, PT, DPT, PhD, 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


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