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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04985578
Other study ID # CBAS-2018-11C
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date February 2022

Study information

Verified date September 2021
Source Universitat Internacional de Catalunya
Contact Albert Pérez-Bellmunt
Phone 636817297
Email aperez@uic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date February 2022
Est. primary completion date January 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Other:
Dry needling
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.
Sham dry needling
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.

Locations

Country Name City State
Spain Universitat Internacional Catalunya Barcelona Sant Cugat

Sponsors (1)

Lead Sponsor Collaborator
Universitat Internacional de Catalunya

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Jump Force (Newtons) Jump Force will be measured using the Myjump app. Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Jump Height (centimeters) Jump Height will be measured using the Myjump app. Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
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