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

NCT04287517 | Completed Results FDA Device

• 1 other identifier: Capacitive-resistive Therapy
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Pain Syndrome of Neck

Keywords

Myofascial Neck Pain; Capacitive-resistive Therapy

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline, pre-intervention and 24 hours after the last intervention

• 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.

  baseline, pre-intervention and 24 hours after the last intervention

Secondary Outcomes (3)

• 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 Arms (2)

Capacitive-Resistive Therapy Group

ACTIVE COMPARATOR

This group was treated with capacitive resistive diathermy and exercise

Device: Capacitive-Resistive Therapy

Sham Group

SHAM COMPARATOR

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

Device: Capacitive-Resistive Therapy

Interventions

Capacitive-Resistive Therapy DEVICE

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

Also known as: Exercise

Capacitive-Resistive Therapy Group; Sham Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul University Faculty of Medicine Sports Medicine Department

Istanbul, 34450, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30892438 BACKGROUND

• 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.

  PMID: 25042309 BACKGROUND

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Sergen Devran, Residency in Istanbul University Sports Medicine Department
• Organization: Istanbul University Faculty of Medicine Sports Medicine Department

sergendevran@gmail.com

00905377782594

Study Officials

• Sensu Dincer, Dr.

  Istanbul University Faculty of Medicine Sports Medicine Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Sports Medicine Residency, Medical Doctor

Study Record Dates

• First Submitted: February 21, 2020
• First Posted: February 27, 2020
• Study Start: December 12, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: June 2, 2020
• Results First Posted: April 15, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)