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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04287517

Enrollment

Registered

2020-02-27

Start date

2019-12-12

Completion date

2020-03-15

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myofascial Pain Syndrome of Neck

Keywords

Myofascial Neck Pain, Capacitive-resistive Therapy

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.

Interventions

DEVICECapacitive-Resistive Therapy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Visual Analog Scale (VAS) Score Change	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.
Pain Pressure Threshold (PPT) Score Change	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

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

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

Forty volunteer patients who had active pain in the neck region for the last 1 month, who applied to our clinic (Istanbul University Faculty of Medicine Sports Medicine Department), between 12 December 2019 - 01 March 2020, and who had an active myofascial trigger point were evaluated and included in the study.

Pre-assignment details

Although 2 patients met the diagnostic criteria, they were not included in the study due to cervical hernia and cervical stenosis.

Participants by arm

Arm	Count
Capacitive-Resistive Therapy Group This group was treated with capacitive resistive diathermy and exercise Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.	18
Sham Group This group was treated with sham capacitive-resistive diathermy and exercise Capacitive-Resistive Therapy: Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.	18
Total	36

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Total	Sham Group	Capacitive-Resistive Therapy Group
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	0 Participants	0 Participants	0 Participants
Age, Categorical Between 18 and 65 years	36 Participants	18 Participants	18 Participants
Age, Continuous	42.9 years STANDARD_DEVIATION 9.5	43.7 years STANDARD_DEVIATION 10.7	42.2 years STANDARD_DEVIATION 8.4
BMI	24.5 kg/m2 STANDARD_DEVIATION 4.2	25.8 kg/m2 STANDARD_DEVIATION 4.2	23.3 kg/m2 STANDARD_DEVIATION 4
Height	164.5 centimeters STANDARD_DEVIATION 8.2	165.3 centimeters STANDARD_DEVIATION 10	163.7 centimeters STANDARD_DEVIATION 6.3
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	36 Participants	18 Participants	18 Participants
Region of Enrollment Turkey	36 participants	18 participants	18 participants
Sex: Female, Male Female	33 Participants	15 Participants	18 Participants
Sex: Female, Male Male	3 Participants	3 Participants	0 Participants
weight	66.2 kg STANDARD_DEVIATION 11.5	70.4 kg STANDARD_DEVIATION 12.8	62.0 kg STANDARD_DEVIATION 8.4

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 18	0 / 18
other Total, other adverse events	0 / 18	0 / 18
serious Total, serious adverse events	0 / 18	0 / 18

Outcome results

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.