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

International Hellenic University

Status: Completed

Conditions: Neck Pain

Treatments: Other: Conventional TENS; Other: Sham TENS; Other: Myofascial release with TENS conductive glove; Other: Myofascial release without TENS conductive glove

Study type: Interventional

Funder types: Other

Identifiers

NCT05367752

EC-03/2022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 22 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 4 patient groups

Group 1: Myofascial release with TENS conductive glove

Experimental group

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.

Treatment:

Other: Myofascial release with TENS conductive glove

Group 2: Myofascial release without TENS conductive glove

Experimental group

Description:

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

Treatment:

Other: Myofascial release without TENS conductive glove

Group 3: Conventional TENS

Experimental group

Description:

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

Treatment:

Other: Conventional TENS

Control: Sham TENS

Active Comparator group

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.

Treatment:

Other: Sham TENS