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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capacitive-Resistive Therapy Group | Active Comparator | This group was treated with capacitive resistive diathermy and exercise |
|
| Sham Group | Sham Comparator | This group was treated with sham capacitive-resistive diathermy and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capacitive-Resistive Therapy | Device | Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sensu Dincer, Dr. | Istanbul University Faculty of Medicine Sports Medicine Department | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istanbul University Faculty of Medicine Sports Medicine Department | Istanbul | 34450 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30892438 | Background | 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. | |
| 25042309 |
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Patients do not want to share the data with anyone other than the researchers involved in the study.
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Although 2 patients met the diagnostic criteria, they were not included in the study due to cervical hernia and cervical stenosis.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Sham Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention and 24 hours after the last intervention |
|
In the study conducted between 12 December 2019 - 15 May 2020, no adverse effects were encountered before, during or after the 10 treatment sessions, an average of three weeks, process applied to patients.
No side effects were seen. As in many physical therapy modalities, our study did not show any side effects. In the capacitive resistive therapy method used as a deep tissue heater, there is no side effect defined in the literature before.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sergen Devran, Residency in Istanbul University Sports Medicine Department | Istanbul University Faculty of Medicine Sports Medicine Department | 00905377782594 | sergendevran@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2020 | Mar 19, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 10, 2019 | Mar 19, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
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| 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 |
| 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| weight | Mean | Standard Deviation | kg |
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| BMI | Mean | Standard Deviation | kg/m2 |
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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.
|
|
| 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. | Posted | Mean | Standard Deviation | N/m^2 | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | Degree | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, pre-intervention and 24 hours after the last intervention |
|
|
|
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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| D013812 |
| Therapeutics |
| D026741 | Physical Therapy Modalities |
| Left Side pre-intervention |
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| Left Side 24 hours after the last intervention |
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| Extension ROM pre-intervention |
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| Extension ROM 24 hours after the last intervention |
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| Left Lateral Flexion ROM pre-intervention |
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| Left Lateral Flexion ROM 24 hours after the last i |
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| Right Lateral Flexion ROM pre-intervention |
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| Right Lateral Flexion ROM 24 hours after the last |
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| Left Lateral Rotation ROM pre-intervention |
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| Left Lateral Rotation ROM 24 hours after the last |
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| Right Lateral Rotation ROM pre-intervention |
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| Right Lateral Rotation ROM 24 hours after the last |
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| Physical Role Functioning pre-intervention |
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| Physical Role Functioning 24 hours after the last |
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| Bodily Pain pre-intervention |
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| Bodily Pain 24 hours after the last intervention |
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| General Health Perceptions pre-intervention |
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| General Health Perceptions 24 hours after the last |
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| Vitality pre-intervention |
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| Vitality 24 hours after the last intervention |
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| Social Role Functioning pre-intervention |
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| Social Role Functioning 24 hours after the last in |
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| Emotional Role Functioning pre-intervention |
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| Emotional Role Functioning 24 hours after the last |
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| Mental Health pre-intervention |
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| Mental Health 24 hours after the last intervention |
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