NCT04255186

Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Interventions

Type	Name	Description
DEVICE	Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency	Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
DEVICE	Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency	Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
DEVICE	Sham stimulation	a simulated stimulation protocol so that the device does not emit current

Timeline

• Start date: 2020-02-03
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2020-02-05
• Last updated: 2021-09-30

Locations

1 site across 1 country: Spain