Effects of MR With TENS Conductive Glove in Adults With Neck Myofascial Syndrome.

August 3, 2022 updated by: Dimitrios Lytras, International Hellenic University

Short-term Effects of Myofascial Release With TENS Conductive Glove in Pain, Range of Motion and Functional Disability in Adults With Neck Myofascial Syndrome: A Randomized Clinical Trial Study

Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release and the application of TENS currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck. 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of myofascial release with conductive TENS glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional ability with the "Neck Disability Index" (NDI) questionnaire.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background: Myofascial neck syndrome has a high incidence in the general population and is characterized by the presence of painful trigger points in the neck muscles. Both the application of manual techniques such as myofascial release (MR) and the application of transcutaneous electrical nerve stimulation (TENS) currents to the painful points of the neck muscles have been proven to help reduce pain and improve the range of motion of the neck.

Aim: To study the efficacy of the combination of MR and the simultaneous application of TENS currents in the painful points of the upper part of the trapezius muscle. The myofascial release protocol will be applied with a conductive glove, which will be connected to a TENS device so that the physiotherapist's hand can be used simultaneously as a mobile electrode.

Method: 80 adults who will present at least one trigger point in the upper trapezius muscle will be randomly divided into four groups. In the first group, a combination therapy of MR with a TENS conductive glove will be applied, in the second group the same protocol of myofascial release without conductive glove, in the third group a high frequency (conventional) TENS, and the fourth group will get placebo TENS with the device closed. All participants will follow a total of six treatments over a period of three weeks with a follow-up after one month. The following will be evaluated before and after the intervention, as well as in the one-month follow-up: pain with the visual analog scale (VAS pain), Pressure Pain Threshold (PPT) in the upper trapezius muscle with a digital algometer, range of motion (ROM) of the neck with a goniometer, and functional disability with the "Neck Disability Index" (NDI) questionnaire. For the statistical analysis of the results, a two-way ANOVA with repeated measurements will be applied.

Expected results: The combination protocol proposed in this clinical study combines the beneficial effects of TENS with the benefits of MR. For this reason, this combination is expected to be more effective than their individual application in improving the clinical picture of adults with myofascial neck syndrome.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Sindos Thessaloníki
      • Thessaloníki, Sindos Thessaloníki, Greece, 57 400
        • Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of at least one trigger point in the upper part of the trapezius muscle
  • Age range 22-60 years
  • Scoring 10% or higher on the Neck Disability Index
  • Scoring of 20mm or more on the Visual Analogue Scale of pain at initial evaluation
  • Written consent to participate in the study

Exclusion Criteria:

  • History of acute neck injury
  • Sensory disorders in the neck area
  • Diagnosis with a serious illness (cancer, severe osteoporosis, infectious or inflammatory processes, fractures, congenital anomalies)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group 1: Myofascial release with TENS conductive glove
Participants allocated to this group received six sessions of a myofascial release protocol with a TENS conductive glove applying a TENS current of 120Hz frequency through an electrotherapy device.
Other: Myofascial release with TENS conductive glove

Before each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle.

Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles.
Experimental: Group 2: Myofascial release without TENS conductive glove
Participants allocated to this group received the same myofascial release protocol with group 1 without the TENS conductive glove.
Other: Myofascial release without TENS conductive glove

Before each MR session, light massage and stretching was applied for five minutes as preparation for the manipulations. The massage included the effleurage technique followed by petrissage and kneading on the cervical and thoracic areas (on the upper three parts of the trapezius muscle, in the suboccipital area, and on the paraspinal cervical muscles). Stretching was applied to the following muscles: upper part of the trapezius, levator scapulae, and the sternocleidomastoid muscle.

Upper trapezius myofascial release, unilateral gross stretch, vertical gross stretch, focused stretch, cranial base myofascial release, gross release of the sternocleidomastoid muscle, and release of the suprahyoid and infrahyoid muscles.
Experimental: Group 3: Conventional TENS
Participants allocated to this group received the application of a conventional TENS current.
Other: Conventional TENS
Two 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021)
Active Comparator: Control: Sham TENS
Participants allocated to this group received the same TENS treatment with group 3, but with the current intensity set to zero to ensure that they received no current.
Other: Sham TENS
Two 40*50mm silicone electrodes were placed with the negative electrode on the trigger point of the trapezius muscle and the positive one on the acromion. The current frequency was 120Hz and pulse duration 80ms for 30 minutes. This protocol has been proposed by Ebadi et al. (2021)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in neck pain intensity with visual analogue scale (VAS)
Time Frame: pre-treatment, week: 1, 3, 7
VAS is a card with an uncalibrated scale ranging from 0-100 mm on the one side (with zero representing no pain and 100 representing the worst pain in life) with each millimeter representing one pain level. The patient subjectively estimated his or her pain level by marking a vertical line on the uncalibrated scale between zero and one hundred. Then the exact value of pain intensity could be obtained with a single ruler. Hence, the higher the value, the more intense the pain. VAS is widely used as it is easy to implement and is characterized by good psychometric properties.
pre-treatment, week: 1, 3, 7
Changes in Pressure Pain threshold with pressure algometry
Time Frame: pre-treatment, week: 1, 3, 7
Pressure pain threshold (PPT) is defined as the minimal amount of pressure that produces pain. PPT was assessed by a digital algometer. Pressure pain threshold was assessed over the upper border of the trapezius muscle halfway between the midline and the lateral border of the acromion. The metal rod of the algometer was placed vertically on the site and the examiner applied gradually increasing pressure at a rate of 1Kg/s. PPT was calculated in kg/cm2.
pre-treatment, week: 1, 3, 7
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Time Frame: pre-treatment, week: 1, 3, 7
Changes in functional capacity with the Greek Version of Neck disability index questionnaire It is a self-reported ten-item scale. Each item assesses different neck pain complaints. Most of the items are related to restrictions in activities of daily living, and each item is expressed by 6 different assertions in the range 0-5, with 0 indicating no disability and 5 indicating the highest disability. The total score ranges from 0 to 50. Disability Index (NDI) has sufficient support in the literature, being the most commonly used to report neck pain.
pre-treatment, week: 1, 3, 7
Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
Time Frame: pre-treatment, week: 1, 3, 7
Cervical active range of motion was measured with 2 bubble inclinometers. One was placed on the top of the head and the second on the spinous process of C7.Active cervical flexion, extension and side bending range of motion were assessed with participants sitting in upright position. Range of motion was measured in degrees. To measure the right and left range of flexion, a long universal goniometer will be placed at the top of the head. The arms of the goniometer will be positioned in such a way that they form a right angle with each other. One arm should face forward, while the second should look to the side towards the side of the turn to be made by the examinee, so that the goniometer reading at the beginning of the measurement is 90°. The patient will then make a turn while the examiner follows the movement without displacing the center of the goniometer.
pre-treatment, week: 1, 3, 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
International Hellenic University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Paris Iakovidis, PhD, International Hellenic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 5, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 10, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 4, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EC-03/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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