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Clinical Trials/NCT04287517
NCT04287517
Completed
Not Applicable

Efficacy of Capacitive-Resistive Therapy on the Treatment of Neck/Upper Trapezius Myofascial Pain: A Randomized Double-Blind Placebo-Controlled Study

Istanbul University1 site in 1 country40 target enrollmentDecember 12, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Myofascial Pain Syndrome of Neck
Sponsor
Istanbul University
Enrollment
40
Locations
1
Primary Endpoint
Visual Analog Scale (VAS) Score Change
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2019
End Date
March 15, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sergen Devran

Principal Investigator, Sports Medicine Residency, Medical Doctor

Istanbul University

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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS) Score Change

Time Frame: baseline, pre-intervention and 24 hours after the last intervention

The VAS is a tool used to help a person rate the intensity of certain sensations and feelings. This Outcome Measure will assess pain. This VAS is a straight horizontal line of fixed length from 0 to 10 cm with 0 cm indicating no pain and 10 cm indicating the worst pain imaginable.

Pain Pressure Threshold (PPT) Score Change

Time Frame: baseline, pre-intervention and 24 hours after the last intervention

PPT is defined as the minimum force applied which induces pain. This measure has proven to be commonly useful in evaluating tenderness symptom. Higher scores mean better outcome.

Secondary Outcomes

  • Neck Disability Index (NDI) Score Change(baseline, pre-intervention and 24 hours after the last intervention)
  • Cervical Range of Motion (cROM) Change(baseline, pre-intervention and 24 hours after the last intervention)
  • Short Form - 36 (SF-36) Score Change(baseline, pre-intervention and 24 hours after the last intervention)

Study Sites (1)

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