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Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles

Primary Purpose

Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
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

Eligibility Criteria

18 Years - 80 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

  • Albert Pérez-Bellmunt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dry needling Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Pressure Pain Threshold (Kg/cm2)
The pressure pain threshold is the amount of pressure that is first perceived as painful. In this study, it will be assessed over the gastrocnemius TrP with a handheld mechanical pressure algometer (Trigger Plus, Pal- patronic, Hagen, Germany). Pressure will be applied at a rate of 10 N/cm2/s until the participant first reported a painful sensation. This procedure has shown good intrarater reliability.
Pain with numerical pain rating scale
Participants will be also asked to rate their pain perception during the pressure pain threshold on an 11-point numerical pain rating scale (0 = no pain, 10 = maximum pain).
Ankle Dorsiflexion Range of Motion (º)
Active ankle dorsiflexion range of motion will be assessed with the dorsiflexion lunge test. The test will be performed by placing the foot perpendicular to a wall and lunging the knee toward the wall. The foot will be moved further away from the wall until the maximum range of dorsiflexion was achieved. In order for the heel to not lift off of the floor, the examiner will place a band under the heel and applied tension. The angulation from the tibia bone to the floor will be measured. The dorsiflexion lunge test has shown good intrarater and interrater reliability (intraclass correlation coefficient = 0.97).
Muscle Strentch (Newtons)
A dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah) was used for isometric muscle-strength testing. All participants will barefoot during the testing procedure. Peak force will be measured by the dynamometer to the nearest 0.1 N. Contractions will be sustained for 3 seconds while the examiner applied unmoving resistance. Both gastrocnemius-testing will be repeated for 3 trials, with a 5-second rest between them. The mean of the 3 trials will be considered in the analysis.

Full Information

First Posted
September 28, 2020
Last Updated
July 7, 2021
Sponsor
Universitat Internacional de Catalunya
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1. Study Identification

Unique Protocol Identification Number
NCT04851743
Brief Title
Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles
Official Title
Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles: A Randomized Within-Participant Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
May 10, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 6, 2021 (Actual)

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 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.

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized within-participant clinical trial
Masking
Outcomes Assessor
Masking Description
the assessor will not know if patients have received the dry needling technique or not.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neuromuscular Function (MyotonPro device) (Hz)
Description
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).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Tensomyography (m/s)
Description
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.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold (Kg/cm2)
Description
The pressure pain threshold is the amount of pressure that is first perceived as painful. In this study, it will be assessed over the gastrocnemius TrP with a handheld mechanical pressure algometer (Trigger Plus, Pal- patronic, Hagen, Germany). Pressure will be applied at a rate of 10 N/cm2/s until the participant first reported a painful sensation. This procedure has shown good intrarater reliability.
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Pain with numerical pain rating scale
Description
Participants will be also asked to rate their pain perception during the pressure pain threshold on an 11-point numerical pain rating scale (0 = no pain, 10 = maximum pain).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Ankle Dorsiflexion Range of Motion (º)
Description
Active ankle dorsiflexion range of motion will be assessed with the dorsiflexion lunge test. The test will be performed by placing the foot perpendicular to a wall and lunging the knee toward the wall. The foot will be moved further away from the wall until the maximum range of dorsiflexion was achieved. In order for the heel to not lift off of the floor, the examiner will place a band under the heel and applied tension. The angulation from the tibia bone to the floor will be measured. The dorsiflexion lunge test has shown good intrarater and interrater reliability (intraclass correlation coefficient = 0.97).
Time Frame
Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Muscle Strentch (Newtons)
Description
A dynamometer (MicroFET2, Hoggan Scientific, Salt Lake City, Utah) was used for isometric muscle-strength testing. All participants will barefoot during the testing procedure. Peak force will be measured by the dynamometer to the nearest 0.1 N. Contractions will be sustained for 3 seconds while the examiner applied unmoving resistance. Both gastrocnemius-testing will be repeated for 3 trials, with a 5-second rest between them. The mean of the 3 trials will be considered in the analysis.
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
80 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.
Facility Information:
Facility Name
Albert Pérez-Bellmunt
City
Sant Cugat del Vallès
State/Province
Barcelona
ZIP/Postal Code
08017
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects on Neuromuscular Function After Dry Needling in Myofascial Trigger Points in the Gastrocnemius Muscles

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