NCT04161105

Brief Summary

This study evaluates the impact of treating myofascial trigger points with a single session of dry needling on maximal isometric strength in the short term. Two groups will receive dry needling in separate muscle groups and a third group will receive no dry needling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

November 11, 2019

Last Update Submit

February 13, 2020

Conditions

Keywords

Dry needlingStrengthLatent trigger points

Outcome Measures

Primary Outcomes (6)

  • Isometric peak force during the isometric mid-thigh pull

    Measured in newtons. It is the amount of force exerted by pulling against an immovable bar. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

  • Isometric peak rate of force development during the isometric mid-thigh pull

    Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. It is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

  • Relative isometric peak force during the isometric mid-thigh pull

    Measured in newtons per kg body weight. It is the amount of force exerted by pulling against an immovable bar divided by two thirds the participants body weight. Peak force is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

  • Relative isometric peak rate of force development during the isometric mid-thigh pull

    Measured in newtons per second squared per kg. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by two thirds the participants body weight. It is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

  • Normalised isometric peak rate of force development during the isometric mid-thigh pull

    Measured in newtons per second squared and expressed relative to each participant peak force. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force divided by the peak vertical ground reaction force produced during the trial. It is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

  • Isometric time interval rate of force development during the isometric mid-thigh pull

    Measured in newtons per second squared. It is the amount of force exerted by pulling against an immovable bar divided by the amount of time it takes to generate the force. With values expressed in specific time interval windows (0ms to 50ms, 0-100ms, 0-150ms, 0-200ms, 0-250ms) It is measured as vertical ground reaction by force platforms beneath the participants feet.

    Baseline, 24 hours post intervention, 48 hours post intervention, 72 hours post intervention.

Study Arms (3)

Rectus femoris dry needling group

EXPERIMENTAL

The rectus femoris dry needling group will have their strength assessed. They will then receive one treatment of dry needling to a trigger point in their rectus femoris muscle. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling.

Procedure: Dry needling

Gluteus maximus dry needling group

EXPERIMENTAL

The gluteus maximus dry needling group will have their strength assessed. They will then receive one treatment of dry needling to trigger points in their gluteus maximus muscle only. They will have their strength re-assessed 24, 48 \& 72 hours after dry needling.

Procedure: Dry needling

Control

NO INTERVENTION

This group will receive no intervention. They will have their strength assessed at baseline and 24, 48 \& 72 hour follow-up

Interventions

Dry needlingPROCEDURE

Dry needling is an invasive procedure involving inserting acupuncture needles directly into trigger points within muscles. The needle is partially withdrawn and re-inserted repeatedly to maximally stimulate the muscle and it's fibers.

Also known as: Myofascial dry needling
Gluteus maximus dry needling groupRectus femoris dry needling group

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Must have latent trigger points in their rectus femoris and gluteus maximus

You may not qualify if:

  • Active trigger points in rectus femoris or gluteus maximus
  • Participants with current injuries
  • History of fibromyalgia or myofascial pain syndrome
  • History of blood disorder which prevents dry needling
  • Needle phobia
  • History of surgery in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Technology Carlow

Carlow, Leinster, Ireland

Location

MeSH Terms

Interventions

Dry Needling

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Darragh O' Meara, BSc

    Institute of Technology, Carlow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The principal investigator will gather data using a force platform and computer software. It will be anonymised and group allocation will be concealed by a second investigator before being individually analysed by the principal investigator. The second investigator will be given the individually analysed data and he/she will sort the individual data into relevant groups for group analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with latent trigger points in rectus femoris (RF) and gluteus maximus (GM) muscles will be stratified evenly into 3 groups (RF dry needling, GM dry needling or control) based on baseline strength. Treatment, data collection and data analysis of all participants will be conducted concurrently.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2019

First Posted

November 13, 2019

Study Start

September 16, 2019

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

February 17, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations