NCT05367752

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: International Hellenic University · Academic / Other
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neck Pain

Interventions

Type	Name	Description
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.
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.
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)
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)

Timeline

• Start date: 2022-04-01
• Primary completion: 2022-06-15
• Completion: 2022-06-15
• First posted: 2022-05-10
• Last updated: 2022-08-04

Locations

1 site across 1 country: Greece