Efficacy of Capacitive-Resistive Therapy on the Treatment of Myofascial Pain

NCT ID: NCT04287517

Last Updated: 2020-06-02

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2020-03-15

Brief Summary

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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.

Detailed Description

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Conditions

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Myofascial Pain Syndrome of Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Capacitive-Resistive Therapy Group

This group was treated with capacitive resistive diathermy and exercise

Group Type ACTIVE_COMPARATOR

Capacitive-Resistive Therapy

Intervention Type DEVICE

Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.

Sham Group

This group was treated with sham capacitive-resistive diathermy and exercise

Group Type SHAM_COMPARATOR

Capacitive-Resistive Therapy

Intervention Type DEVICE

Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.

Interventions

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Capacitive-Resistive Therapy

Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.

Intervention Type DEVICE

Other Intervention Names

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Exercise

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Sergen Devran

Principal Investigator, Sports Medicine Residency, Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sensu Dincer, Dr.

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Faculty of Medicine Sports Medicine Department

Locations

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Istanbul University Faculty of Medicine Sports Medicine Department

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30892438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25042309 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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Capacitive-resistive Therapy

Identifier Type: -

Identifier Source: org_study_id

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