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Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles

Primary Purpose

Myofascial Trigger Point Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sham dry needling
Sponsored by
Universitat Internacional de Catalunya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring dry needling, gastrocnemius, myofascial trigger point, Superficial Electromyography

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universitat Internacional CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Dry needling Group

Sham dry needling

Control

Arm Description

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.

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.

No Treatment will be perfomed in this group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Jump Force (Newtons)
Jump Force will be measured using the Myjump app.
Jump Height (centimeters)
Jump Height will be measured using the Myjump app.

Full Information

First Posted
July 22, 2021
Last Updated
September 28, 2021
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04985578
Brief Title
Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles
Official Title
Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitat Internacional de Catalunya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
dry needling, gastrocnemius, myofascial trigger point, Superficial Electromyography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized controlled trial
Masking
Outcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham dry needling
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Treatment will be perfomed in this group
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Muscle activity (microVolts)
Description
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.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Jump Force (Newtons)
Description
Jump Force will be measured using the Myjump app.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Jump Height (centimeters)
Description
Jump Height will be measured using the Myjump app.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Albert Pérez-Bellmunt
Phone
636817297
Ext
+34
Email
aperez@uic.cat
Facility Information:
Facility Name
Universitat Internacional Catalunya
City
Barcelona
State/Province
Sant Cugat
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacobo Rodríguez-Sanz, Dr.
Phone
636136789
Ext
+34
Email
jrodriguez@uic.es

12. IPD Sharing Statement

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Effects on Muscle Activity After Dry Needling in Myofascial Trigger Points of the Gastrocnemius Muscles

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