- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01734577
Effect of Dry Needling Multifidus on Thickness of Transversus Abdominis in Healthy Individuals
June 17, 2013 updated by: Emilio, University of Nevada, Las Vegas
The Effect of Trigger Point Dry Needling to the Multifidus Muscle on Resting and Contracted Thickness of Transversus Abdominis in Healthy Subjects
Intramuscular therapy (also known as dry needling) has been shown to give dramatic relief of musculoskeletal pain.
The mechanisms of action remain unknown, and this study will examine for a neurophysiological effect.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Consenting adults will be taught how to contract their abdominal muscles, and to contract transversus abdominis in particular.
They will then have real time ultrasound measurements of the resting and contracted thickness of their left transversus abdominis muscle.
After this, they will receive actual or sham needling to their left multifidus muscle by another researchers blinded to the real time ultrasound measurements.
After needling or sham intervention is complete, the original researchers will return to re-measure transversus abdominis.
They will be blind to intervention allocation.
Study Type
Interventional
Enrollment (Actual)
60
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 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age, absence of back pain or symptoms for greater than 6 months and ability to perform DCC. Subjects must also report they are comfortable with being 'needled'.
Exclusion Criteria:
- Presence of back pain or symptoms within the last 6 months, history of: abdominal or spinal surgery, significant scoliosis, rheumatoid arthritis, osteoporosis, osteopenia, active ankylosing spondylitis. If a subject reports a fear of needles.
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: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dry needling
Monofilament needles will be inserted into each subject's left multifidus muscle and stimulated mechanically for a local twitch response
|
Sterile monofilament needles
|
|
Sham Comparator: Sham needling
Monofilament tubes will be pressed into the left multifidus muscle and mechanically manipulated to give the sensation that needling is occuring.
|
Applicator tubes from the sterile monofilament needles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Thickness of transversus abdominis at rest and during contraction
Time Frame: 1 day
|
Real time ultrasound measurement
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Daniella Morton, BSc, University of Nevada Las Vegas Physical Therapy
- Study Director: Sarah Buckingham, BSc, University of Nevada Las Vegas Physical Therapy
- Study Director: Crystal Montoya, BSc, Univesity of Nevada Las Vegas Physical Therapy
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
August 1, 2012
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
November 21, 2012
First Submitted That Met QC Criteria
November 26, 2012
First Posted (Estimate)
November 27, 2012
Study Record Updates
Last Update Posted (Estimate)
June 19, 2013
Last Update Submitted That Met QC Criteria
June 17, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UNLVPT-4059
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.