Manipulation Effects on Abdominal Muscles
This study is currently recruiting participants.
Verified December 2012 by University of Nevada, Las Vegas
Sponsor:
University of Nevada, Las Vegas
Information provided by (Responsible Party):
Emilio, University of Nevada
ClinicalTrials.gov Identifier:
NCT01745939
First received: December 5, 2012
Last updated: December 7, 2012
Last verified: December 2012
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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 2013 |
| Estimated Primary Completion Date: | August 2013 (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 |
| ClinicalTrials.gov Identifier: | NCT01745939 History of Changes |
| Other Study ID Numbers: | UNLVPT-4056 |
| Study First Received: | December 5, 2012 |
| Last Updated: | December 7, 2012 |
| 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 June 17, 2013