NCT04851743

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 neuromuscular function, pain perception, and basic physical properties in myofascial trigger points (TrPs) after a single treatment session of dry needling in the gastrocnemius muscle. A randomized within-participant clinical trial with a blinded assessor will be conducted. 50 asymptomatic volunteers (100 gastrocnemius-muscle) with MrPs gastrocnemius-muscle TrPs will bilaterally explored. Each extremity will be randomly assigned to the control group (no treatment) or the experimental group (60 seconds of dry needling over each TrP). Neuromuscular function of the gastrocnemius muscle will be assessed using a MyotonPro and a tensiomyography. Muscle flexibility will be analyzed using the lunge test and the passive ankle range of motion. The strength will be determined with a handheld dynamometer (MicroFET2). Pain perception will be analyzed with a 0-to-10 numerical pain rating scale and determination of pressure pain thresholds over each latent TrP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

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

First Submitted

Initial submission to the registry

September 28, 2020

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 20, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2021

Completed
Last Updated

July 8, 2021

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

September 28, 2020

Last Update Submit

July 7, 2021

Conditions

Keywords

dry needlinggastrocnemiusmyofascial trigger point

Outcome Measures

Primary Outcomes (2)

  • Neuromuscular Function (MyotonPro device) (Hz)

    The Neuromuscular function will be assessed with a handheld MyotonPro myotonometry device, which will be placed on the skin, perpendicular to the surface of the belly of each gastrocnemius muscle, with the participant prone. The device will then lowered into the measurement position and held steady while it automatically conducted the predefined measurement series. The program consist of 3 single measurements with a recording interval of 1 second for each muscle. The average valuevfor each site will used in subsequent analyses. The reliability of the MyotonPro device has been reported to range from good to excellent (intraclass correlation coefficient = 0.8-0.93).

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

  • Tensomyography (m/s)

    The Tensomyography evaluation will be done by using a Dc-Dc Trans-Tek® transductor (GK 40, Panoptik d.o.o., Ljubliana, Slovenia) that will be perpendicularly placed to the gastrocnemius belly. Two self-adhesive electrodes (TMG electrodes, TMG-BMC d.o.o., Ljubljana, Slovenia) will be placed equidistant, proximal (anode) and distal (cathode) to the sensor, with an inter-electrode distance of 5 cm. Patient will be placed in prone position with a foam Electrical stimulation was applied through a TMG-100 System electrostimulator (TMG-BMCd.o.o., Ljubljana, Slovenia). The amplitude will be progressively increased from 20 to 100 mA by 20 mA increments until there will be no further increase in maximal radial displacement or maximal stimulator output was reached (i.e 110mA) (20). Ten seconds rest will be given between the stimuli to minimize the effects of fatigue and potentiation. The meters per second of muscle contraction with the electrical stimulus will be measured.

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

Secondary Outcomes (4)

  • Pressure Pain Threshold (Kg/cm2)

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

  • Pain with numerical pain rating scale

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

  • Ankle Dorsiflexion Range of Motion (º)

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

  • Muscle Strentch (Newtons)

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

Study Arms (2)

Dry needling Group

EXPERIMENTAL

Participants will be used as their own controls, with 1 lower extremity randomly receiving intervention. The experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds.

Other: Dry needling

Control Group

NO INTERVENTION

Participants will be used as their own controls, with 1lower extremity randomly receiving intervention. The control extremity did not receive any intervention, and outcomes were assessed 2 minutes apart.

Interventions

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

Dry needling Group

Eligibility Criteria

Age18 Years - 80 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)

Albert Pérez-Bellmunt

Sant Cugat del Vallès, Barcelona, 08017, Spain

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized within-participant clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director Human Anatomy Laboratory

Study Record Dates

First Submitted

September 28, 2020

First Posted

April 20, 2021

Study Start

May 10, 2021

Primary Completion

July 1, 2021

Study Completion

July 6, 2021

Last Updated

July 8, 2021

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations