NCT03689283

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

October 25, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2020

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

September 25, 2018

Last Update Submit

January 21, 2020

Conditions

Trigger Point Pain, Myofascial

Outcome Measures

Primary Outcomes (1)

  • MyotonPRO

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

    2 years

Secondary Outcomes (3)

  • Knee to wall

    2 years

  • GAITRite

    2 years

  • Handheld dynamometer

    2 years

Study Arms (2)

Dry Needling Group

EXPERIMENTAL

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

Other: Dry Needling

Control Group

SHAM COMPARATOR

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

Other: Sham Dry Needlling

Interventions

Dry NeedlingOTHER

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

Dry Needling Group
Sham Dry NeedllingOTHER

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

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Regis University

Denver, Colorado, 80221, United States

Location

Related Publications (4)

  • 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.

    PMID: 22837285BACKGROUND

  • 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.

    PMID: 29181252BACKGROUND

  • 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.

    PMID: 22222143BACKGROUND

  • 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.

    PMID: 15834340BACKGROUND

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Stephanie Albin, PhD

    Regis University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to group allocation. Participants in the control group will receive sham needling.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Prospective randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

September 25, 2018

First Posted

September 28, 2018

Study Start

October 25, 2018

Primary Completion

December 31, 2019

Study Completion

January 21, 2020

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)