Clinical trial NCT05367752: 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
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Keywords: Neck Pain
Myofascial trigger points
Myofascial release
Transcutaneous electrical nerve stimulation
Physiotherapy
Lead sponsor: International Hellenic University
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 80
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Changes in neck pain intensity with visual analogue scale (VAS)
timeFrame: pre-treatment, week: 1, 3, 7
measure: Changes in Pressure Pain threshold with pressure algometry
timeFrame: pre-treatment, week: 1, 3, 7
measure: Changes in functional capacity with the Greek Version of Neck disability index questionnaire
timeFrame: pre-treatment, week: 1, 3, 7
measure: Changes in Cervical Range of Motion with bubble inclinometers and a universal goniometer
timeFrame: pre-treatment, week: 1, 3, 7
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Department of Physiotherapy, Faculty of Health Sciences International Hellenic University
state: Sindos Thessaloníki
Study officials:
affiliation: International Hellenic University
name: Paris Iakovidis, PhD
role: STUDY_DIRECTOR
References: