Hospital General Universitario Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600, Spain
NCT Number: NCT04255186
The purpose of this study is to assess the effectiveness of 448 kHz capacitive resistive monopolar radiofrequency in the treatment of subacromial syndrome.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Talavera de la Reina, Toledo, 45600, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Other names: CRMRF
Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
a simulated stimulation protocol so that the device does not emit current
Time frame: Baseline
minimun 0 - maximun10. Higher scores mean a worse outcome
Time frame: After 3 weeks
minimun 0 - maximun10. Higher scores mean a worse outcome
Time frame: 1 month after the end of the intervention
minimun 0 - maximun10. Higher scores mean a worse outcome
Time frame: 3 months after the end of the intervention
minimun 0 - maximun10. Higher scores mean a worse outcome
Time frame: Baseline
Shoulder Pain and Disabilty Index
Time frame: After 3 weeks
Shoulder Pain and Disabilty Index
Time frame: 1 month after the end of the intervention
Shoulder Pain and Disabilty Index
Time frame: 3 months after the end of the intervention
Shoulder Pain and Disabilty Index
Time frame: Baseline
Abbreviated
Time frame: After 3 weeks
Abbreviated
Time frame: 1 month after the end of the intervention
Abbreviated
Time frame: 3 months after the end of the intervention
Abbreviated
Time frame: Baseline
Pressure Pain Threshold in subacromial area
Time frame: After 3 weeks
Pressure Pain Threshold in subacromial area
Time frame: Baseline
Higher scores mean a better outcome
Time frame: After 3 weeks
Higher scores mean a better outcome
Time frame: 1 month after the end of the intervention
Higher scores mean a better outcome
Time frame: 3 months after the end of the intervention
Higher scores mean a better outcome
Time frame: Baseline
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time frame: After 3 weeks
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time frame: 1 month after the end of the intervention
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time frame: 3 months after the end of the intervention
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time frame: After three weeks
The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.
Time frame: 3 months after the end of the intervention
The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.
Time frame: 3 months after the end of the intervention
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.
University of Castilla-La Mancha
Other
Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.
Acronym: CRMRF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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