NCT03876080

Brief Summary

Investigation of the biomechanical response in delayed onset muscle soreness using dry needling vs. sham

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

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

February 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

March 30, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 23, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

4.2 years

First QC Date

February 5, 2019

Last Update Submit

July 26, 2023

Conditions

Delayed Onset Muscle Soreness

Outcome Measures

Primary Outcomes (1)

  • Change in Biomechanical stiffness (N/m) using MyotonPRO

    Measuring Biomechanical stiffness ( N/m) change at the following time frames

    baseline, immediately after intervention, 24 hours after intervention

Secondary Outcomes (1)

  • Change in Pressure pain threshold using pressure algometry

    baseline, immediately after intervention, 24 hours after intervention

Study Arms (2)

Dry needling

EXPERIMENTAL

Dry needling intervention to the gastrocnemius muscle trigger point

Other: Dry needling

Sham needling

SHAM COMPARATOR

Sham dry needling intervention to the gastrocnemius muscle trigger point

Other: Sham needling

Interventions

Dry needlingOTHER

The use of a solid filiform needle to treat trigger points

Dry needling
Sham needlingOTHER

Simulated needling

Sham needling

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bradley University

Peoria, Illinois, 61625, United States

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 5, 2019

First Posted

March 15, 2019

Study Start

March 30, 2019

Primary Completion

May 23, 2023

Study Completion

May 23, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)