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

Myofascial Pain Syndrome of Neck Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287517
• Other study ID #: Capacitive-resistive Therapy
• Status: Completed
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: March 15, 2020

Study information

• Verified date: May 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome of Neck
• Myofascial Pain Syndromes

Intervention

Device:
• Capacitive-Resistive Therapy
Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.

Locations

Country	Name	City	State
Turkey	Istanbul University Faculty of Medicine Sports Medicine Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Diego IMA, Fernández-Carnero J, Val SL, Cano-de-la-Cuerda R, Calvo-Lobo C, Piédrola 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline, pre-intervention and 24 hours after the last intervention
Secondary	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.	baseline, pre-intervention and 24 hours after the last intervention
Secondary	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.	baseline, pre-intervention and 24 hours after the last intervention