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Completed

NCT Number: NCT04287517

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Faculty of Medicine Sports Medicine Department

Istanbul, 34450, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capacitive-Resistive Therapy

Device

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

Other names: Exercise

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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