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

Primary Purpose

Myofascial Pain Syndrome of Neck

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Capacitive-Resistive Therapy
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome of Neck focused on measuring Myofascial Neck Pain, Capacitive-resistive Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University Faculty of Medicine Sports Medicine Department

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Capacitive-Resistive Therapy Group

Sham Group

Arm Description

This group was treated with capacitive resistive diathermy and exercise

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

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS) Score Change
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
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 Outcome Measures

Neck Disability Index (NDI) Score Change
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.
Cervical Range of Motion (cROM) Change
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.
Short Form - 36 (SF-36) Score Change
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.

Full Information

First Posted
February 21, 2020
Last Updated
May 21, 2020
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04287517
Brief Title
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

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
March 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome of Neck
Keywords
Myofascial Neck Pain, Capacitive-resistive Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Capacitive-Resistive Therapy Group
Arm Type
Active Comparator
Arm Description
This group was treated with capacitive resistive diathermy and exercise
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
This group was treated with sham capacitive-resistive diathermy and exercise
Intervention Type
Device
Intervention Name(s)
Capacitive-Resistive Therapy
Other Intervention Name(s)
Exercise
Intervention Description
Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS) Score Change
Description
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.
Time Frame
baseline, pre-intervention and 24 hours after the last intervention
Title
Pain Pressure Threshold (PPT) Score Change
Description
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.
Time Frame
baseline, pre-intervention and 24 hours after the last intervention
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI) Score Change
Description
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.
Time Frame
baseline, pre-intervention and 24 hours after the last intervention
Title
Cervical Range of Motion (cROM) Change
Description
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.
Time Frame
baseline, pre-intervention and 24 hours after the last intervention
Title
Short Form - 36 (SF-36) Score Change
Description
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.
Time Frame
baseline, pre-intervention and 24 hours after the last intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sensu Dincer, Dr.
Organizational Affiliation
Istanbul University Faculty of Medicine Sports Medicine Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Faculty of Medicine Sports Medicine Department
City
Istanbul
ZIP/Postal Code
34450
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Patients do not want to share the data with anyone other than the researchers involved in the study.
Citations:
PubMed Identifier
30892438
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. Erratum In: Rev Assoc Med Bras (1992). 2019 Jul 22;65(6):931.
Results Reference
background
PubMed Identifier
25042309
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.
Results Reference
background

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

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