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| Name | Class |
|---|---|
| Hospital General Nuestra Señora del Prado | OTHER |
| Castilla-La Mancha Health Service | OTHER |
| Indiba S.A. | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Thermal CRMRF | Experimental | 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 |
|
| Subthermal CRMRF | Experimental | 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). |
|
| Sham CRMRF | Sham Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency | Device | Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quick DASH | Abbreviated | Baseline |
| Quick DASH | Abbreviated | After 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Medication intake | Analgesic ladder for chronic pain. Higher scores mean a worse outcome | Baseline |
| Medication intake | Analgesic ladder for chronic pain. Higher scores mean a worse outcome |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juan Avendaño-Coy, PhD | Castilla La Mancha University | Principal Investigator |
| Javier Aceituno-Gómez, PhD | Castilla-La Mancha Health Service | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario Nuestra Señora del Prado | Talavera de la Reina | Toledo | 45600 | Spain |
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| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
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|
| Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency | Device | Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method |
|
| Sham stimulation | Device | a simulated stimulation protocol so that the device does not emit current |
|
| 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 |
| After 3 weeks |
| Medication intake | Analgesic ladder for chronic pain. Higher scores mean a worse outcome | 1 month after the end of the intervention |
| Medication intake | Analgesic ladder for chronic pain. Higher scores mean a worse outcome | 3 months after the end of the intervention |
| Blinding assesment | The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging. | After three weeks |
| Blinding assesment | The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging. | 3 months after the end of the intervention |
| Total number of sessions of the exercise protocol for discharge | After the first 3 weeks, if the patient has not met the criteria for discharge, more sessions will continue performing the same exercise protocol according to medical criteria. This total number of sessions will be recorded. | 3 months after the end of the intervention |
| D018771 |
| Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |