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Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points

Primary Purpose

Muscle Tonus

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound Therapy
Digital Capacitive Diathermy Therapy
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Tonus focused on measuring Myofascial trigger point, Trapezius Muscle, Diathermy, Ultrasound

Eligibility Criteria

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

Inclusion Criteria:

  • Older than 18 years
  • Presence of an active or latent MTrP 1 in the upper trapezius:

    • Presence of taut band in a skeletal muscle.
    • Presence of a hypersensitive point in the taut band.
    • Local twitch response caused by palpation of the taut band.
    • Reproduction of the typical referred pain pattern of MTrPs in response to compression.
    • Spontaneous presence of the typical pain pattern and/or patient's recognition of that pain as familiar (criteria only applicable to the active MTrPs).

Exclusion Criteria:

  • History of neurological disorders (radiculopathy).
  • Cervical surgery.
  • Chronic pain in any part of the body as a result of a traumatic incident.
  • Chronic rheumatic disease.
  • Medical diagnosis of fibromyalgia.
  • Systemic diseases.
  • Actual pregnancy.
  • Clinical depression.
  • Body mass index ≥30.
  • To receive treatment of myofascial syndrome in the muscles of the cervico-dorsal area (physical therapy, invasive techniques ...) during the month prior to the beginning of the study.
  • Ingestion of medication (analgesics, muscle relaxants, psychotropic or anti-inflammatory agents) in the three days prior to the start of the study.

Exit criteria:

  • Patient´s petition.
  • Appearance of any lesion that might contraindicate the use of electrotherapy techniques.

Sites / Locations

  • Universidad San Jorge

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

US Group

DCD Group

Arm Description

Ultrasound Therapy

Digital Capacitive Diathermy Therapy

Outcomes

Primary Outcome Measures

Change in Stiffness
The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Change in Decrement (elasticity)
Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Change in Frequency
Frequency of muscle oscillations (Hz) is an indicator of the tone. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle. The assessment is realized in these points: MTrP 1 of the affected superior trapezius. MTrP 3 of the affected superior trapezius. MTrP 1 of the NO affected superior trapezius. Point in the middle of the muscle belly of the affected superior trapezius. 10 mechanical stimuli of 0.4 N of force and 0.15 ms of duration will be applied. The MyotonPro® must remain perpendicular to the surface to be measured (the subject will be lying in a prone position for the MTrP 3, and sit down for the three other points). Each assessment will consist of 10 multiple measurements, spaced for 1 second. To be considerate as valid, the variation coefficient of the measure should not exceed 3%.

Secondary Outcome Measures

Change in the Pressure Pain Threshold (PPT)
The PPT is measured using a pressure algometer in these points: MTrP 1 of the affected superior trapezius. MTrP 3 of the affected superior trapezius. MTrP 1 of the NO affected superior trapezius. MTrP 2 of the lateral gastrocnemius of the affected side. The subject will be lying in a prone position for more stability and with a pillow under his feet. The algometer must remain perpendicular to the surface to be measured. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Change in the Range Of Motion (ROM) of cervical spine lateral inclination
It will be used a portable inclinometer to assess the ROM of the contralateral active cervical spine inclination. The subject will be in a relaxed and comfortable sitting position, leaning on the backrest, arms resting on his knees and fixing a point with his eyes. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Change in Pain Perception
Change in pain perception using Numeric Pain Rating Scale (NPRS). The NPRS is a scale from 0-10 ("0" = no pain; "10" = the most intense pain imaginable).
Change in Neck Disability Index (NDI)
The NDI consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation.

Full Information

First Posted
May 2, 2017
Last Updated
May 2, 2018
Sponsor
Universidad San Jorge
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1. Study Identification

Unique Protocol Identification Number
NCT03154632
Brief Title
Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points
Official Title
Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
October 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge

4. Oversight

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

5. Study Description

Brief Summary
The main objective: To compare the effect on muscle tone between the application of digital capacitive diathermy and the application of ultrasound on the myofascial trigger points (MTP) of the upper trapezius muscle. Hypothesis: The application of digital capacitive diathermy on myofascial trigger points of the trapezius muscle compared to the application of ultrasound produces objective changes in muscle tone, and this change is superior to the changes generated by the US.
Detailed Description
It is a simple-blinded randomized crossover clinical trial where volunteer subjects, older than 18 years, have a latent or active proximal MTP1 (intermediate part of the anterior margin of the upper part of the muscle near the vertical fibers of the muscle attached to clavicle) in the upper trapezius. It will assess if there are changes in the muscle tone of the trapezius muscle after applying digital capacitive diathermy (DCD) or ultrasound (US) in the latent or active MTP1 of the trapezius muscle in healthy adults. Each patient will receive a single session of each treatment in the affected trapezius. The order in which treatments are received - US followed by digital capacitive diathermy, or vice versa - is determined at random. To remove any carryover of effects, there will be a week of washing period between the two interventions. Intervention: - DCD: The patient is positioned in prone position on stretcher. Firstly, it will apply almonds oil on the MTP1 of the upper trapezius affected. Then, it will put the "musculotendinous injury FAST" program which lasts 6 minutes; and, it will move the ultrasound applicator in contact with the skin with a velocity approximately between 2.5 and 4 centimeters per second. - US: The patient is positioned in prone position on the stretcher. Firstly, it will select parameters (frequency: 1MHz, intensity: 1.0 W/cm2, mode: continuous). Then it will apply a slow technique of circular movements with a speed of approximately between 2.5 and 4 centimeters per second over the area of the MTP1 of the upper trapezius affected during 6 minutes. Assessment: To assess the effectiveness of these techniques, several tests will be performed on the subjects: Myotonometric measurements using a myotonometer to obtain frequency, decrement (elasticity) and stiffness of the evaluated points and MTPs. Algometry results will bring information of the PPT of evaluated MTPs. The 0-10 Numeric Pain Rating Scale results will bring information of the subjective dolor perception of the subjects. Inclinometer results will bring information of the ROM of cervical spine lateral inclination. The Neck Disability Index results will provide information on how much neck pain interferes in the daily activities of patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Tonus
Keywords
Myofascial trigger point, Trapezius Muscle, Diathermy, Ultrasound

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
US Group
Arm Type
Active Comparator
Arm Description
Ultrasound Therapy
Arm Title
DCD Group
Arm Type
Active Comparator
Arm Description
Digital Capacitive Diathermy Therapy
Intervention Type
Device
Intervention Name(s)
Ultrasound Therapy
Intervention Description
Ultrasound equipment will be used, choosing a continuous mode, with a frequency of 1MHz and an intensity of 1.0 W/cm2. The technique will be applied during 6 minutes with circular movements and a speed of approximately between 2.5 and 4 centimeters per second.
Intervention Type
Device
Intervention Name(s)
Digital Capacitive Diathermy Therapy
Intervention Description
The DCD equipment will be used choosing the "musculotendinous injury FAST" program which lasts 6 minutes. The applicator will move with a velocity approximately between 2.5 and 4 centimeters per second.
Primary Outcome Measure Information:
Title
Change in Stiffness
Description
The muscle stiffness reflects muscle resistance to the force that changes its shape (Nm). This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Title
Change in Decrement (elasticity)
Description
Logarithmic decrement of the dampening of muscle oscillations is an indicator of the elasticity. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle.
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Title
Change in Frequency
Description
Frequency of muscle oscillations (Hz) is an indicator of the tone. This outcome measure is obtained by a device named MyotonPro®. It is a non-invasive commercial device made to calculate myotonometric properties of the muscle. The assessment is realized in these points: MTrP 1 of the affected superior trapezius. MTrP 3 of the affected superior trapezius. MTrP 1 of the NO affected superior trapezius. Point in the middle of the muscle belly of the affected superior trapezius. 10 mechanical stimuli of 0.4 N of force and 0.15 ms of duration will be applied. The MyotonPro® must remain perpendicular to the surface to be measured (the subject will be lying in a prone position for the MTrP 3, and sit down for the three other points). Each assessment will consist of 10 multiple measurements, spaced for 1 second. To be considerate as valid, the variation coefficient of the measure should not exceed 3%.
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Secondary Outcome Measure Information:
Title
Change in the Pressure Pain Threshold (PPT)
Description
The PPT is measured using a pressure algometer in these points: MTrP 1 of the affected superior trapezius. MTrP 3 of the affected superior trapezius. MTrP 1 of the NO affected superior trapezius. MTrP 2 of the lateral gastrocnemius of the affected side. The subject will be lying in a prone position for more stability and with a pillow under his feet. The algometer must remain perpendicular to the surface to be measured. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Title
Change in the Range Of Motion (ROM) of cervical spine lateral inclination
Description
It will be used a portable inclinometer to assess the ROM of the contralateral active cervical spine inclination. The subject will be in a relaxed and comfortable sitting position, leaning on the backrest, arms resting on his knees and fixing a point with his eyes. It will be measured three consecutive times, with an interval of 30 seconds between each measurement.
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Title
Change in Pain Perception
Description
Change in pain perception using Numeric Pain Rating Scale (NPRS). The NPRS is a scale from 0-10 ("0" = no pain; "10" = the most intense pain imaginable).
Time Frame
Pre-intervention; Post-intervention (30 minutes after intervention); Follow up (1 week after the intervention).
Title
Change in Neck Disability Index (NDI)
Description
The NDI consists of ten questions in the following domains: Pain Intensity, Personal Care, Lifting, Reading, Headaches, Concentration, Work, Driving, Sleeping, and Recreation.
Time Frame
Pre-intervention; Follow up (1 week after the intervention).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Older than 18 years Presence of an active or latent MTrP 1 in the upper trapezius: Presence of taut band in a skeletal muscle. Presence of a hypersensitive point in the taut band. Local twitch response caused by palpation of the taut band. Reproduction of the typical referred pain pattern of MTrPs in response to compression. Spontaneous presence of the typical pain pattern and/or patient's recognition of that pain as familiar (criteria only applicable to the active MTrPs). Exclusion Criteria: History of neurological disorders (radiculopathy). Cervical surgery. Chronic pain in any part of the body as a result of a traumatic incident. Chronic rheumatic disease. Medical diagnosis of fibromyalgia. Systemic diseases. Actual pregnancy. Clinical depression. Body mass index ≥30. To receive treatment of myofascial syndrome in the muscles of the cervico-dorsal area (physical therapy, invasive techniques ...) during the month prior to the beginning of the study. Ingestion of medication (analgesics, muscle relaxants, psychotropic or anti-inflammatory agents) in the three days prior to the start of the study. Exit criteria: Patient´s petition. Appearance of any lesion that might contraindicate the use of electrotherapy techniques.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolina Jiménez-Sánchez, MSc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maria Ortiz-Lucas, PhD
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad San Jorge
City
Villanueva de Gállego
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Effectiveness of Digital Capacitive Diathermy Versus Ultrasound on Myofascial Trigger Points

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