- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03689283
The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points
January 21, 2020 updated by: Stephanie Albin, Regis University
The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Latent Trigger Points
This study would be the first study to assess the immediate effects of dry needling of latent trigger points of the gastrocnemius muscle on muscle stiffness, gait, range of motion, and strength.
The study has the potential to demonstrate that dry needling may have immediate effects on mechanical properties of muscle and may thus guide future treatment for individuals with changes in muscle tissue secondary to pain and/or injury.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will complete the following tests: muscle stiffness testing in both a relaxed and contracted position, GAITRite for spatial and temporal gait characteristics, the Ankle Lunge Test (ALT) to assess range of motion, and calf strength using a dynamometer.
Subjects will then receive treatment according to which group they are randomized.
Muscle stiffness, gait, motion and strength will be reassessed immediately following treatment at the first session.
Four to10 days later, participants will complete the same tests and measures prior to treatment being administered a second time.
Another 4-10 days after the second session, participants will complete the tests and measures one final time.
Study Type
Interventional
Enrollment (Actual)
102
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
-
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Colorado
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Denver, Colorado, United States, 80221
- Regis University
-
-
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 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-50 years
- Able to read and speak sufficient English to complete consent form
- Symmetrical gait pattern demonstrated through observation
- Presence of latent trigger point in gastrocnemius muscle
Exclusion Criteria:
- Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
- Any prior acupuncture or dry needling within the past month
- History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
- Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
- Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
- No specific calf injury in the past 6 months
- Participants known or thought to be pregnant
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: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry Needling Group
Individuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle.
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Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle
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Sham Comparator: Control Group
Individuals in the control group will receive two treatment sessions of sham dry needling.
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Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MyotonPRO
Time Frame: 2 years
|
Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee to wall
Time Frame: 2 years
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Group by time differences will be assessed for talocrural motion (knee to wall)
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2 years
|
GAITRite
Time Frame: 2 years
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Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)
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2 years
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Handheld dynamometer
Time Frame: 2 years
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Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephanie Albin, PhD, Regis University
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.
General Publications
- Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.
- Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.
- Bandy WD, Nelson R, Beamer L. COMPARISON OF DRY NEEDLING VS. SHAM ON THE PERFORMANCE OF VERTICAL JUMP. Int J Sports Phys Ther. 2017 Oct;12(5):747-751.
- Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.
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 (Actual)
October 25, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
January 21, 2020
Study Registration Dates
First Submitted
September 25, 2018
First Submitted That Met QC Criteria
September 26, 2018
First Posted (Actual)
September 28, 2018
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 21, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RegisU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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