- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01745939
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
Intervention / Treatment
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.
Sponsor
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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