NCT04864704

Brief Summary

60 healthy participants were randomized into infraspinatus, erector spinae, or gastrocnemius groups. One session of dry needling DN was applied to the muscle in standardized location. Stiffness was assessed using a MyotonPRO at baseline, immediately post DN, and 24 hours later. The presence of a localized twitch response (LTR) during DN was used to subgroup participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable healthy

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

Study Start

First participant enrolled

January 30, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2015

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 29, 2021

Completed
Last Updated

April 29, 2021

Status Verified

April 1, 2021

Enrollment Period

1 year

First QC Date

April 20, 2021

Last Update Submit

April 25, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Change in Stiffness

    Biomechanical stiffness of the muscle measured, non-invasively using a MyotonPRO. Stiffness (N/m)

    Change from baseline and immediately post intervention

Study Arms (3)

Infraspinatus

ACTIVE COMPARATOR

Subjects infraspinatus stiffness was measured and observed

Other: dry needling

Erector spinae

ACTIVE COMPARATOR

Subjects erector spinae stiffness was measured and observed

Other: dry needling

Gastrocnemius

ACTIVE COMPARATOR

Subjects gastrocnemius stiffness was measured and observed

Other: dry needling

Interventions

dry needlingOTHER

Physical therapy

Erector spinaeGastrocnemiusInfraspinatus

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women ages 18 to 65 years
  • reported good general health
  • tenderness or palpable trigger point in the muscle (infraspinatus, gastrocnemius, or erector spinae)

You may not qualify if:

  • BMI \> 30kg/m2
  • surgery in the prior 12 months
  • current pain in the shoulder, low back, and lower leg
  • precautions to dry needling treatment (anticoagulant medications, bleeding disorders, known pregnancy)

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
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 29, 2021

Study Start

January 30, 2014

Primary Completion

January 30, 2015

Study Completion

January 30, 2015

Last Updated

April 29, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Data will not be shared

Locations

US(1)