Clinical trial NCT04287517: Efficacy of Capacitive-Resistive Therapy on the Treatment of Myofascial Pain
Official title: Efficacy of Capacitive-Resistive Therapy on the Treatment of Neck/Upper Trapezius Myofascial Pain: A Randomized Double-Blind Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndrome of Neck
Keywords: Myofascial Neck Pain
Capacitive-resistive Therapy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Myofascial pain syndrome (MPS) is a painful musculoskeletal condition affecting the individuals' daily life presenting with muscle spasm, referred pain patterns, stiffness, restricted range of motion caused by trigger points. Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves. Currently, although this modality is used to treat various acute or chronic musculoskeletal disorders, there is no specific data about myofascial trigger points in the literature. The investigators aimed to evaluate the efficacy of capacitive-resistive diathermy on the myofascial trigger point of neck/upper trapezius muscle area compared with the sham intervention of capacitive-resistive diathermy.

Volunteers with active myofascial trigger points in the upper trapezius and neck were included the study after being examined by sports medicine specialists. Exclusion criteria were fibromyalgia, discal hernia, radiculopathy, myelopathy, having received trigger point injection and physical therapy within the last 1 month, neck or back surgery, rheumatismal diseases, pregnancy. Patients were randomly allocated into two groups. Group 1 will be treated with capacitive resistive diathermy and exercise. Group 2 will be treated with placebo (sham) capacitive-resistive diathermy and exercise for 10 sessions at intervals of 24-48 hours. Visual analog scale (VAS), neck disability index (NDI) score, cervical range of motion (cROM), active trigger point numbers will be evaluated before and after treatment. The study was designed as a prospective, randomized, placebo-controlled double-blind trial. The study was approved by the Istanbul Faculty of Medicine Ethics Committee. All participants were informed of the study and signed written informed consent.


Eligibility criteria: Inclusion Criteria:

* Volunteers
* Active myofascial trigger points in the upper trapezius and neck

Exclusion Criteria:

* Fibromyalgia
* Discal Hernia
* Radiculopathy, Myelopathy
* Having received trigger point injection and physical therapy within the last 1 month
* Neck or Back surgery
* Rheumatismal diseases
* Pregnancy

Primary outcomes:
measure: Visual Analog Scale (VAS) Score Change
timeFrame: baseline, pre-intervention and 24 hours after the last intervention
measure: Pain Pressure Threshold (PPT) Score Change
timeFrame: baseline, pre-intervention and 24 hours after the last intervention
Secondary outcomes:
measure: Neck Disability Index (NDI) Score Change
timeFrame: baseline, pre-intervention and 24 hours after the last intervention
measure: Cervical Range of Motion (cROM) Change
timeFrame: baseline, pre-intervention and 24 hours after the last intervention
measure: Short Form - 36 (SF-36) Score Change
timeFrame: baseline, pre-intervention and 24 hours after the last intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Faculty of Medicine Sports Medicine Department
Study officials:
affiliation: Istanbul University Faculty of Medicine Sports Medicine Department
name: Sensu Dincer, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diego IMA, Fernandez-Carnero J, Val SL, Cano-de-la-Cuerda R, Calvo-Lobo C, Piedrola RM, Oliva LCL, Rueda FM. Analgesic effects of a capacitive-resistive monopolar radiofrequency in patients with myofascial chronic neck pain: a pilot randomized controlled trial. Rev Assoc Med Bras (1992). 2019 Feb;65(2):156-164. doi: 10.1590/1806-9282.65.2.156.
citation: Ong J, Claydon LS. The effect of dry needling for myofascial trigger points in the neck and shoulders: a systematic review and meta-analysis. J Bodyw Mov Ther. 2014 Jul;18(3):390-8. doi: 10.1016/j.jbmt.2013.11.009. Epub 2013 Nov 9.