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

May 21, 2020 updated by: Sergen Devran, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34450
        • Istanbul University Faculty of Medicine Sports Medicine Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Capacitive-Resistive Therapy Group
This group was treated with capacitive resistive diathermy and exercise
Device: Capacitive-Resistive Therapy
Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
Other Names:
  • Exercise
Sham Comparator: Sham Group
This group was treated with sham capacitive-resistive diathermy and exercise
Device: Capacitive-Resistive Therapy
Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
Other Names:
  • Exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, pre-intervention and 24 hours after the last intervention
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.
baseline, pre-intervention and 24 hours after the last intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neck Disability Index (NDI) Score Change
Time Frame: baseline, pre-intervention and 24 hours after the last intervention
The Neck Disability Index (NDI) is a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain. Each question has six statement, the first statement is marked the section score = 0, if the last statement is marked it = 5. Maximum score is 50 and minimum is 0. Lower scores mean better outcome.
baseline, pre-intervention and 24 hours after the last intervention
Cervical Range of Motion (cROM) Change
Time Frame: baseline, pre-intervention and 24 hours after the last intervention
The cervical spine's range of motion is approximately 80° to 90° of flexion, 70° of extension, 20° to 45° of lateral flexion, and up to 90° of rotation to both sides.
baseline, pre-intervention and 24 hours after the last intervention
Short Form - 36 (SF-36) Score Change
Time Frame: baseline, pre-intervention and 24 hours after the last intervention
The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status and an abbreviated variant of it. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
baseline, pre-intervention and 24 hours after the last intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: Sensu Dincer, Dr., Istanbul University Faculty of Medicine Sports Medicine Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2019

Primary Completion (Actual)

March 15, 2020

Study Completion (Actual)

March 15, 2020

Study Registration Dates

First Submitted

February 21, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

June 2, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Capacitive-resistive Therapy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Patients do not want to share the data with anyone other than the researchers involved in the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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