NCT04985578

Brief Summary

Trigger points (TrPs) are a common musculoskeletal cause of local and referred muscle pain, as well as local inflammation in the muscle and fascia. From a clinical and sensory viewpoint, TrPs may be classified as active or latent. The principal difference is the reproduction of symptoms experienced by an individual (active) with or without stimulation. Local and referred pain elicited from latent TrPs may be transient in duration upon stimulation, and latent TrPs may be present without spontaneous symptoms. Both active and latent TrPs induce motor dysfunctions such as stiffness, restricted range of motion, and accelerated fatigability in the affected muscle. The interrater reliability of manual identification of latent TrPs in the calf muscles has been found to range from small to moderate. The clinical relevance of latent TrPs has increased in the last decade,4 and some studies have investigated the effects of treating them. Among all manual therapies targeted to latent TrPs, ischemic compression, or TrP pressure release, is the most commonly used. Although TrPs may affect any muscle, the gastrocnemius muscle may be the most susceptible in the lower extremity to developing them. It has been reported that 13% to 30% of the asymptomatic population has latent TrPs in these muscles, and their presence may affect sport practice. The purpose of this study will be to evaluate changes in muscle activity in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle. A randomized controlled clinical trial with blinded assessor will be conducted. 90 asymptomatic volunteers with MrPs gastrocnemius -muscle TrPs will bilaterally explored. After exploration the volunteer will be asigned to either Control (no treatment), experimental (60 seconds of dry needling on the TrP that refers more pain on the randomly assigned extremity) or sham group (60 seconds of dry needling on the TrP that refers more pain with a sham needle with no tip). To be part of the sham group patients should not have received any dry needling before. Muscle activity is commonly recorded in research using surface electromyography (sEMG). sEMG has previously been used in similar studies because it is less invasive than intramuscular electromyography. Electromyography will be performed using the mDurance® surface electromyograph (mDurance Solutions SL; Granada, Spain) in order to capture muscle activity of the lateral and medial Gastrocnemius muscles (Electrodes will be placed as described by the mDurance application) during an unilateral countermovement Jump (in both extremities) and 20 meter Sprint. There will be a resting period of at least 2 minutes between exercises to prevent the results from being affected by fatigue.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

July 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

September 29, 2021

Status Verified

September 1, 2021

Enrollment Period

4 months

First QC Date

July 22, 2021

Last Update Submit

September 28, 2021

Conditions

Keywords

dry needlinggastrocnemiusmyofascial trigger pointSuperficial Electromyography

Outcome Measures

Primary Outcomes (1)

  • Muscle activity (microVolts)

    sEMG is a NON-invasive method that measures the electrical activity of the muscle generated by the passage of the nerve impulse, which causes depolarization of the muscle cell membrane during excitation. Once the muscle is contracted and receives electrical signals, the electrodes pick up these signals and record them on the device application.

    Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

Secondary Outcomes (2)

  • Jump Force (Newtons)

    Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Jump Height (centimeters)

    Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

Study Arms (3)

Dry needling Group

EXPERIMENTAL

The experimental extremity will be assigned randomly and will receive a single treatment session of TrP dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds.

Other: Dry needling

Sham dry needling

PLACEBO COMPARATOR

The experimental extremity will be assigned randomly and will receive a single treatment session of TrP sham dry needling as follows: the therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, sham dry needling technique will be performed on the TrP for 60 seconds with a needle without tip.

Other: Sham dry needling

Control

NO INTERVENTION

No Treatment will be perfomed in this group

Interventions

The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds.

Dry needling Group

The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds with a sham needle without tip.

Sham dry needling

Eligibility Criteria

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

You may qualify if:

  • A TrP will be diagnosed using the following criteria: palpable taut band, presence of a painful spot in the taut band, and referred pain on palpation of the spot.

You may not qualify if:

  • Participants were excluded if they reported any pain symptoms in the lower extremities in the previous year.
  • They were also excluded if they presented previous surgical interventions, previous lower-extremity injury, any underlying medical disease, pregnancy, or muscle soreness after vigorous exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional Catalunya

Barcelona, Sant Cugat, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Albert Pérez-Bellmunt

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will not know if patients have received the dry needling technique or not. Participants in the sham group will told they will receive a normal dry needling protocol
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2021

First Posted

August 2, 2021

Study Start

September 1, 2021

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

September 29, 2021

Record last verified: 2021-09

Locations