- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864704
Immediate Decrease of Muscle Biomechanical Stiffness Following Dry Needling in Asymptomatic Participants
April 25, 2021 updated by: Joseph Kelly, Bradley University
60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups.
One session of dry needling DN was applied to the muscle in standardized location.
Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later.
The presence of a localized twitch response (LTR) during DN was used to subgroup participants.
Study Overview
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
-
-
Illinois
-
Peoria, Illinois, United States, 61625
- Bradley 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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- men and women ages 18 to 65 years
- reported good general health
- tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)
Exclusion Criteria:
- BMI > 30kg/m2
- surgery in the prior 12 months
- current pain in the shoulder, low back, and lower leg
- precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Infraspinatus
Subjects infraspinatus stiffness was measured and observed
|
Physical therapy
|
Active Comparator: Erector spinae
Subjects erector spinae stiffness was measured and observed
|
Physical therapy
|
Active Comparator: Gastrocnemius
Subjects gastrocnemius stiffness was measured and observed
|
Physical therapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Stiffness
Time Frame: Change from baseline and immediately post intervention
|
Biomechanical stiffness of the muscle measured, non-invasively using a MyotonPRO.
Stiffness (N/m)
|
Change from baseline and immediately post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 30, 2014
Primary Completion (Actual)
January 30, 2015
Study Completion (Actual)
January 30, 2015
Study Registration Dates
First Submitted
April 20, 2021
First Submitted That Met QC Criteria
April 25, 2021
First Posted (Actual)
April 29, 2021
Study Record Updates
Last Update Posted (Actual)
April 29, 2021
Last Update Submitted That Met QC Criteria
April 25, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- BradleyU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Data will not be shared
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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