Dry Needling in Subjects With Delayed Onset Muscle Soreness (TDNDOMS)
Primary Purpose
Delayed Onset Muscle Soreness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dry needling
Sham needling
Sponsored by
About this trial
This is an interventional treatment trial for Delayed Onset Muscle Soreness
Eligibility Criteria
Inclusion Criteria:
- The participants of the study will be any healthy male or female between
- age of 18 to 35
- able and willing to perform an exercise protocol using the gastrocnemius muscle
- willing to receive either sham or dry needling intervention
Exclusion Criteria:
- current muscular pain
- prior trigger point therapy in the past 6 months
- medications that affect muscle function
- injury in the past 6 months
- any health condition that prevents exercising
- recent surgery
Sites / Locations
- Bradley University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Dry needling
Sham needling
Arm Description
Dry needling intervention to the gastrocnemius muscle trigger point
Sham dry needling intervention to the gastrocnemius muscle trigger point
Outcomes
Primary Outcome Measures
Change in Biomechanical stiffness (N/m) using MyotonPRO
Measuring Biomechanical stiffness ( N/m) change at the following time frames
Secondary Outcome Measures
Change in Pressure pain threshold using pressure algometry
Measuring Pressure pain threshold change at the following time frames
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03876080
Brief Title
Dry Needling in Subjects With Delayed Onset Muscle Soreness
Acronym
TDNDOMS
Official Title
Biomechanical Response to Dry Needling in Subjects With Delayed Onset Muscle Soreness: a Double Blind Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2019 (Actual)
Primary Completion Date
May 23, 2023 (Actual)
Study Completion Date
May 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bradley University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Onset Muscle Soreness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dry needling
Arm Type
Experimental
Arm Description
Dry needling intervention to the gastrocnemius muscle trigger point
Arm Title
Sham needling
Arm Type
Sham Comparator
Arm Description
Sham dry needling intervention to the gastrocnemius muscle trigger point
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
The use of a solid filiform needle to treat trigger points
Intervention Type
Other
Intervention Name(s)
Sham needling
Intervention Description
Simulated needling
Primary Outcome Measure Information:
Title
Change in Biomechanical stiffness (N/m) using MyotonPRO
Description
Measuring Biomechanical stiffness ( N/m) change at the following time frames
Time Frame
baseline, immediately after intervention, 24 hours after intervention
Secondary Outcome Measure Information:
Title
Change in Pressure pain threshold using pressure algometry
Description
Measuring Pressure pain threshold change at the following time frames
Time Frame
baseline, immediately after intervention, 24 hours after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
The participants of the study will be any healthy male or female between
age of 18 to 35
able and willing to perform an exercise protocol using the gastrocnemius muscle
willing to receive either sham or dry needling intervention
Exclusion Criteria:
current muscular pain
prior trigger point therapy in the past 6 months
medications that affect muscle function
injury in the past 6 months
any health condition that prevents exercising
recent surgery
Facility Information:
Facility Name
Bradley University
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61625
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Dry Needling in Subjects With Delayed Onset Muscle Soreness
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