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

Primary Purpose

Trigger Point Pain, Myofascial

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Dry Needling

Sham Dry Needlling

About this trial

This is an interventional treatment trial for Trigger Point Pain, Myofascial

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius
Any prior acupuncture or dry needling within the past month
History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use)
Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait
Restrictions in plantar flexion range of motion which would inhibit performing a heel raise
No specific calf injury in the past 6 months
Participants known or thought to be pregnant

Sites / Locations

Regis University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Dry Needling Group

Control Group

Arm Description

Individuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle.

Individuals in the control group will receive two treatment sessions of sham dry needling.

Outcomes

Primary Outcome Measures

MyotonPRO

Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device

Secondary Outcome Measures

Knee to wall

Group by time differences will be assessed for talocrural motion (knee to wall)

GAITRite

Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)

Handheld dynamometer

Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)

Full Information

NCT ID

NCT03689283

First Posted

September 25, 2018

Last Updated

January 21, 2020

Sponsor

Regis University

1. Study Identification

Unique Protocol Identification Number

NCT03689283

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

October 25, 2018 (Actual)

Primary Completion Date

December 31, 2019 (Actual)

Study Completion Date

January 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Regis University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Trigger Point Pain, Myofascial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Model Description

Prospective randomized controlled trial

Masking

ParticipantOutcomes Assessor

Masking Description

Participants will be blinded to group allocation. Participants in the control group will receive sham needling.

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry Needling Group

Arm Type

Experimental

Arm Description

Individuals in the DN arm will receive two treatment sessions of DN to latent trigger points of the gastrocnemius muscle.

Arm Title

Control Group

Arm Type

Sham Comparator

Arm Description

Individuals in the control group will receive two treatment sessions of sham dry needling.

Intervention Type

Other

Intervention Name(s)

Dry Needling

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham Dry Needlling

Intervention Description

Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle

Primary Outcome Measure Information:

Title

MyotonPRO

Description

Muscle stiffness will be measured in both a resting and contracted state utilizing this non-invasive device

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Knee to wall

Description

Group by time differences will be assessed for talocrural motion (knee to wall)

Time Frame

2 years

Title

GAITRite

Description

Group by time differences will be assessed for gait variables (utilizing the GAITRite 6-meter mat)

Time Frame

2 years

Title

Handheld dynamometer

Description

Group by time differences will be assessed for strength of the gastrosoleus complex (utilizing a handheld dynamometer)

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-50 years Able to read and speak sufficient English to complete consent form Symmetrical gait pattern demonstrated through observation Presence of latent trigger point in gastrocnemius muscle Exclusion Criteria: Any prior foot/ankle surgery, deformity, or injury on the which would affect strength of the gastrocnemius Any prior acupuncture or dry needling within the past month History of systemic disorder in which dry needling would be contraindicated (i.e. bleeding disorders or anticoagulant medication use) Have fractures of the spine, hip, or knee that would likely affect their weight bearing or gait Restrictions in plantar flexion range of motion which would inhibit performing a heel raise No specific calf injury in the past 6 months Participants known or thought to be pregnant

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephanie Albin, PhD

Organizational Affiliation

Regis University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Regis University

City

Denver

State/Province

Colorado

ZIP/Postal Code

80221

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22837285

Citation

Ballyns JJ, Turo D, Otto P, Shah JP, Hammond J, Gebreab T, Gerber LH, Sikdar S. Office-based elastographic technique for quantifying mechanical properties of skeletal muscle. J Ultrasound Med. 2012 Aug;31(8):1209-19. doi: 10.7863/jum.2012.31.8.1209.

Results Reference

background

PubMed Identifier

29181252

Citation

Bandy WD, Nelson R, Beamer L. COMPARISON OF DRY NEEDLING VS. SHAM ON THE PERFORMANCE OF VERTICAL JUMP. Int J Sports Phys Ther. 2017 Oct;12(5):747-751.

Results Reference

background

PubMed Identifier

22222143

Citation

Chuang LL, Wu CY, Lin KC. Reliability, validity, and responsiveness of myotonometric measurement of muscle tone, elasticity, and stiffness in patients with stroke. Arch Phys Med Rehabil. 2012 Mar;93(3):532-40. doi: 10.1016/j.apmr.2011.09.014. Epub 2012 Jan 4.

Results Reference

background

PubMed Identifier

15834340

Citation

Furlan AD, van Tulder M, Cherkin D, Tsukayama H, Lao L, Koes B, Berman B. Acupuncture and dry-needling for low back pain: an updated systematic review within the framework of the cochrane collaboration. Spine (Phila Pa 1976). 2005 Apr 15;30(8):944-63. doi: 10.1097/01.brs.0000158941.21571.01.

Results Reference

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

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