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The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03689283
Recruitment Status : Completed
First Posted : September 28, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Stephanie Albin, Regis University

Tracking Information
First Submitted Date  ICMJE September 25, 2018
First Posted Date  ICMJE September 28, 2018
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE October 25, 2018
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
MyotonPRO [ Time Frame: 2 years ]
Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Knee to wall [ Time Frame: 2 years ]
    Group by time differences will be assessed for talocrural motion (knee to wall)
  • GAITRite [ Time Frame: 2 years ]
    Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)
  • Handheld dynamometer [ Time Frame: 2 years ]
    Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Trigger Points
Official Title  ICMJE The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Latent Trigger Points
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description:
Prospective randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
Participants will be blinded to group allocation. Participants in the control group will receive sham needling.
Primary Purpose: Treatment
Condition  ICMJE Trigger Point Pain, Myofascial
Intervention  ICMJE
  • Other: Dry Needling
    Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle
  • Other: Sham Dry Needlling
    Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle
Study Arms  ICMJE
  • Experimental: Dry Needling Group
    Individuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle.
    Intervention: Other: Dry Needling
  • Sham Comparator: Control Group
    Individuals in the control group will receive two treatment sessions of sham dry needling.
    Intervention: Other: Sham Dry Needlling
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2018)
102
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 21, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 18-50 years
  2. Able to read and speak sufficient English to complete consent form
  3. Symmetrical gait pattern demonstrated through observation
  4. Presence of latent trigger point in gastrocnemius muscle

Exclusion Criteria:

  1. Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
  2. Any prior acupuncture or dry needling within the past month
  3. History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
  4. Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
  5. Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
  6. No specific calf injury in the past 6 months
  7. Participants known or thought to be pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03689283
Other Study ID Numbers  ICMJE RegisU
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Stephanie Albin, Regis University
Study Sponsor  ICMJE Regis University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephanie Albin, PhD Regis University
PRS Account Regis University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP