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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

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.

Condition or disease Intervention/treatment Phase
Trigger Point Pain, Myofascial Other: Dry Needling Other: Sham Dry Needlling Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
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
Official Title: The Effect of Dry Needling on Muscle Stiffness, Gait, Motion, and Strength in Healthy Individuals With Latent Trigger Points
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 21, 2020

Resource links provided by the National Library of Medicine


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.
Other: Dry Needling
Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle

Sham Comparator: Control Group
Individuals in the control group will receive two treatment sessions of sham dry needling.
Other: Sham Dry Needlling
Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle




Primary Outcome Measures :
  1. MyotonPRO [ Time Frame: 2 years ]
    Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device


Secondary Outcome Measures :
  1. Knee to wall [ Time Frame: 2 years ]
    Group by time differences will be assessed for talocrural motion (knee to wall)

  2. GAITRite [ Time Frame: 2 years ]
    Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)

  3. Handheld dynamometer [ Time Frame: 2 years ]
    Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689283


Locations
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United States, Colorado
Regis University
Denver, Colorado, United States, 80221
Sponsors and Collaborators
Regis University
Investigators
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Principal Investigator: Stephanie Albin, PhD Regis University
Publications:
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Responsible Party: Stephanie Albin, Primary Investigator, Regis University
ClinicalTrials.gov Identifier: NCT03689283    
Other Study ID Numbers: RegisU
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases