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

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05367752
• Other study ID #: EC-03/2022
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: August 2022
• Source: International Hellenic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.
• 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.
• 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)
• 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)

Locations

Country	Name	City	State
Greece	Department of Physiotherapy, Faculty of Health Sciences International Hellenic University	Thessaloníki	Sindos Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
International Hellenic University

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pre-treatment, week: 1, 3, 7
Primary	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.	pre-treatment, week: 1, 3, 7
Primary	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.	pre-treatment, week: 1, 3, 7
Primary	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.	pre-treatment, week: 1, 3, 7