search
Back to results

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

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Myofascial release with TENS conductive glove
Myofascial release without TENS conductive glove
Conventional TENS
Sham TENS
Sponsored by
International Hellenic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Neck Pain, Myofascial trigger points, Myofascial release, Transcutaneous electrical nerve stimulation, Physiotherapy

Eligibility Criteria

22 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Physiotherapy, Faculty of Health Sciences International Hellenic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group 1: Myofascial release with TENS conductive glove

Group 2: Myofascial release without TENS conductive glove

Group 3: Conventional TENS

Control: Sham TENS

Arm Description

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.

Participants allocated to this group received the same myofascial release protocol with group 1 without the TENS conductive glove.

Participants allocated to this group received the application of a conventional TENS current.

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.

Outcomes

Primary Outcome Measures

Changes in neck pain intensity with visual analogue scale (VAS)
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.
Changes in Pressure Pain threshold with pressure algometry
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.
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
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.
Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
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.

Secondary Outcome Measures

Full Information

First Posted
May 5, 2022
Last Updated
August 3, 2022
Sponsor
International Hellenic University
search

1. Study Identification

Unique Protocol Identification Number
NCT05367752
Brief Title
Effects of MR With TENS Conductive Glove in Adults With Neck Myofascial Syndrome.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
International Hellenic University

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
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck Pain, Myofascial trigger points, Myofascial release, Transcutaneous electrical nerve stimulation, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
An assessor-blind randomized control trial with a duration of three weeks and a one-month follow up will be performed in 80 adults with neck pain due to the presence of trigger points on the upper part of trapezius muscle. The participants will be allocated into four groups of 20 persons each (three intervention groups and one control group). In the first group, a combination therapy of myofascial release with conductive TENS gloves will be applied, in the second group the same protocol of myofascial release without conductive gloves, 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.
Masking
Outcomes Assessor
Masking Description
Single (Outcomes Assessor) Assessor-blind randomized control trial. A masked assessor conducted the measurements.
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Myofascial release with TENS conductive glove
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2: Myofascial release without TENS conductive glove
Arm Type
Experimental
Arm Description
Participants allocated to this group received the same myofascial release protocol with group 1 without the TENS conductive glove.
Arm Title
Group 3: Conventional TENS
Arm Type
Experimental
Arm Description
Participants allocated to this group received the application of a conventional TENS current.
Arm Title
Control: Sham TENS
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release with TENS conductive glove
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Myofascial release without TENS conductive glove
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional TENS
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Sham TENS
Intervention Description
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)
Primary Outcome Measure Information:
Title
Changes in neck pain intensity with visual analogue scale (VAS)
Description
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.
Time Frame
pre-treatment, week: 1, 3, 7
Title
Changes in Pressure Pain threshold with pressure algometry
Description
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.
Time Frame
pre-treatment, week: 1, 3, 7
Title
Changes in functional capacity with the Greek Version of Neck disability index questionnaire
Description
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.
Time Frame
pre-treatment, week: 1, 3, 7
Title
Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
Description
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.
Time Frame
pre-treatment, week: 1, 3, 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paris Iakovidis, PhD
Organizational Affiliation
International Hellenic University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
City
Thessaloníki
State/Province
Sindos Thessaloníki
ZIP/Postal Code
57 400
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs