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

Study Overview
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Brief Summary
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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.

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

Conditions
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Myofascial Pain Syndrome of Neck

Intervention / Treatment
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* Device: Capacitive-Resistive Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Neck Pain, Capacitive-resistive Therapy