- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02087969
Triceps Surae Trigger Point Size and Muscle Extensibility
December 13, 2017 updated by: Duke University
Effectiveness of Dry Needling to Decrease Trigger Point Size and Increase Soft Tissue Extensibility in the Triceps Surae Muscle as Measured Via Musculoskeletal Ultrasound
The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes.
There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle.
The study will include healthy male subjects between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling of the triceps surae, triceps surae stretching only, dry needling and stretching.
The subjects who receive dry needling as an intervention will have the trigger point identified and dry needling performed while under musculoskeletal ultrasound visualization.
The subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale.
There will be 3 days between the initial testing/intervention and follow up.
These outcomes will be the primary variables of interest.
Ultrasound, Y balance testing, self stretching, and range of motion measurements are safe and pose no risk to the subject.
Dry Needling has been found to be very safe and effective in the hands of physical therapists with a calculated risk of adverse events to be less than 0.04%.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Duke Sports Medicine
-
-
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 30 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male
- 18-30 Years Old
- No history of ankle surgery
- No current ankle injuries
Exclusion Criteria:
- hypothyroidism
- fibromyalgia
- connective tissue disorders
- chronic pain
- bleeding disorders including use of anti-coagulants
- vitamin D and B12 deficiencies
- active sites of cancer
- local or systemic infections
- local skin lesions, local lymphedema
- peripheral vascular disease including varicose veins
- compromised immune system
- needle phobia
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: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Dry Needling
Dry Needling to Triceps Surae
|
|
|
Experimental: Stretching
Subjects will be given a home exercise program of stretches which are commonly prescribed to improve ankle dorsiflexion.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Ankle Dorsiflexion Range Of Motion
Time Frame: Baseline and 10 Minutes
|
Ankle range of motion measures will be record before and immediately after the intervention.
|
Baseline and 10 Minutes
|
|
Change in Ankle Dorsiflexion Range of Motion
Time Frame: Baseline and 3 Days
|
Ankle dorsiflexion will again be measured at three days after the intervention to determine short term effectiveness of results.
|
Baseline and 3 Days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Y-Balance Test for the Lower Quarter
Time Frame: Baseline and 20 Minutes
|
Test of balance and functional performance of lower extremities.
|
Baseline and 20 Minutes
|
|
Change in Y Balance Test for the Lower Quarter
Time Frame: Baseline and 3 Days
|
Y Balance Test for the Lower Quarter will be assessed again at 3 days after the intervention to assess short term effectiveness.
|
Baseline and 3 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chad Cook, PhD, PT, Duke University
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
April 1, 2014
Primary Completion (Actual)
January 1, 2015
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
March 7, 2014
First Submitted That Met QC Criteria
March 12, 2014
First Posted (Estimate)
March 14, 2014
Study Record Updates
Last Update Posted (Actual)
December 15, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
March 1, 2015
More Information
Terms related to this study
Other Study ID Numbers
- Pro00052299
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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