Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

Study Overview
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Brief Summary
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The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.

Detailed Description
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Shoulder pain has a high prevalence in our society, several studies estimate an annual prevalence between 5% and 47%. It is one of the main causes of musculoskeletal pain, particularly in third place, after the low back pain and neck pain. Symptoms of pathologies of subacromial syndrome, where, regardless of origin, pain is the number one symptom for the patient, which emanates functional impairment and the impact on quality of life. Among the non-pharmacological treatments of subacromial syndrome, a systematic review concludes that the first line of intervention should be a therapeutic exercise program. In many cases, this is usually accompanied by the application of electrophysical agents (short wave, laser, etc.). A recent study has shown that the application of Short Wave Radio Frequency improved pain in people with subacromial syndrome. The current frequency that is applied in the short wave is 27.12 MHz, however, there are other relatively new forms of radiofrequency in which a frequency less than 1 MHz is used. These are beginning to be used in clinical practice and recently have shown positive results related to pain and functionality of musculoskeletal pathologies such as knee osteoarthritis. In these two clinical trials, what is called Resistive Capacitive Monopolar Radio Frequency (RFCR) was used, the frequency of which was 448 KHz and 485KHz respectively, much lower than the frequency used in Shortwave. The RFCR has a potential advantage since it is applied with electrodes directly on the skin and is not transmitted in the air unlike the Short Wave. Based on the few clinical trials in people with pathology and the physiological effects evidenced in healthy people and in vitro preclinical studies, it is considered pertinent to carry out the present investigation.

Official Title
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Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.

Conditions
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Shoulder Impingement Syndrome, Subacromial Impingement Syndrome

Intervention / Treatment
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* Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
* Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
* Device: Sham stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 70 years years old with diagnosis of subacromial syndrome Visual Analogue Scale (VAS) less than or equal to 7. Positive Neer and Hawkins test. Exclusion Criteria: Clinical examination compatible with complete rotator cuff tear (Drop-arm positive test) Fibromyalgia Adhesive capsulitis Be receiving physiotherapeutic treatment or have received it previously for this pathology one month before the start of treatment. Patients with alterations of thermal sensitivity. Derived from the absolute and relative contraindications of CRMRF: Pacemaker Thrombophlebitis Pregnancy Skin disorders (recent wounds or burns)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thermal CRMRF<br>9 sessions in 3 week of Thermal CRMRF: The power of the RFCR equipment in this intervention will be 35 VA in capacitive method (10% of the maximum power of the equipment) and 30 W in the resistive method (15% of the maximum power of the equipment) in 3 week (3 sessions a week on alternate days) + 15 sessions in 3 week of exercise protocol (5 sessiones a week). In Thermal CRMRF it will be necessary to adapt to the patient's thermal sensitivity | Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency<br>* Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method<br>* Other names: CRMRF;|
| Experimental: Subthermal CRMRF<br>9 sessions in 3 week of Subthermal CRMRF: The power of the RFCR equipment in this intervention will be 7 VA in capacitive method (2% of the maximum power of the equipment) and 4 W in the resistive method (2% of the maximum power of the equipment) in 3 week (3 sessions a week on alternate days) + 15 sessions in 3 week of exercise protocol (5 sessions a week). | Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency<br>* Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method<br>|
| Sham Comparator: Sham CRMRF<br>9 sessions in 3 week of sham stimulation: The application will be carried out in the same way as in the experimental groups, but in this case the manufacturer will introduce a simulated stimulation protocol so that the device does not emit current + 15 sessions in 3 week of exercise protocol (5 sessiones a week). | Device: Sham stimulation<br>* a simulated stimulation protocol so that the device does not emit current<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | minimun 0 - maximun10. Higher scores mean a worse outcome | Baseline | 
| Visual Analogue Scale | minimun 0 - maximun10. Higher scores mean a worse outcome | After 3 weeks | 
| Visual Analogue Scale | minimun 0 - maximun10. Higher scores mean a worse outcome | 1 month after the end of the intervention | 
| Visual Analogue Scale | minimun 0 - maximun10. Higher scores mean a worse outcome | 3 months after the end of the intervention | 
| SPADI | Shoulder Pain and Disabilty Index | Baseline | 
| SPADI | Shoulder Pain and Disabilty Index | After 3 weeks | 
| SPADI | Shoulder Pain and Disabilty Index | 1 month after the end of the intervention | 
| SPADI | Shoulder Pain and Disabilty Index | 3 months after the end of the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quick DASH | Abbreviated | Baseline | 
| Quick DASH | Abbreviated | After 3 weeks | 
| Quick DASH | Abbreviated | 1 month after the end of the intervention | 
| Quick DASH | Abbreviated | 3 months after the end of the intervention | 
| PPT | Pressure Pain Threshold in subacromial area | Baseline | 
| PPT | Pressure Pain Threshold in subacromial area | After 3 weeks | 
| European Quality ol life - 5 dimensions (EQ-5D) | Higher scores mean a better outcome | Baseline | 
| European Quality ol life - 5 dimensions (EQ-5D) | Higher scores mean a better outcome | After 3 weeks | 
| European Quality ol life - 5 dimensions (EQ-5D) | Higher scores mean a better outcome | 1 month after the end of the intervention | 
| European Quality ol life - 5 dimensions (EQ-5D) | Higher scores mean a better outcome | 3 months after the end of the intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents