Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

Shoulder Impingement Syndrome Clinical Trial

— CRMRF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04255186
• Other study ID #: 448 kHz CRMRF UCLM
• Status: Completed
• Phase: N/A
• Start date: February 3, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2021
• Source: University of Castilla-La Mancha
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: September 15, 2021
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital General Universitario Nuestra Señora del Prado	Talavera de la Reina	Toledo

Sponsors (4)

Lead Sponsor	Collaborator
University of Castilla-La Mancha	Castilla-La Mancha Health Service, Hospital General Nuestra Señora del Prado, Indiba S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medication intake	Analgesic ladder for chronic pain. Higher scores mean a worse outcome	Baseline
Other	Medication intake	Analgesic ladder for chronic pain. Higher scores mean a worse outcome	After 3 weeks
Other	Medication intake	Analgesic ladder for chronic pain. Higher scores mean a worse outcome	1 month after the end of the intervention
Other	Medication intake	Analgesic ladder for chronic pain. Higher scores mean a worse outcome	3 months after the end of the intervention
Other	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
Other	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
Other	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
Primary	Visual Analogue Scale	minimun 0 - maximun10. Higher scores mean a worse outcome	Baseline
Primary	Visual Analogue Scale	minimun 0 - maximun10. Higher scores mean a worse outcome	After 3 weeks
Primary	Visual Analogue Scale	minimun 0 - maximun10. Higher scores mean a worse outcome	1 month after the end of the intervention
Primary	Visual Analogue Scale	minimun 0 - maximun10. Higher scores mean a worse outcome	3 months after the end of the intervention
Primary	SPADI	Shoulder Pain and Disabilty Index	Baseline
Primary	SPADI	Shoulder Pain and Disabilty Index	After 3 weeks
Primary	SPADI	Shoulder Pain and Disabilty Index	1 month after the end of the intervention
Primary	SPADI	Shoulder Pain and Disabilty Index	3 months after the end of the intervention
Secondary	Quick DASH	Abbreviated	Baseline
Secondary	Quick DASH	Abbreviated	After 3 weeks
Secondary	Quick DASH	Abbreviated	1 month after the end of the intervention
Secondary	Quick DASH	Abbreviated	3 months after the end of the intervention
Secondary	PPT	Pressure Pain Threshold in subacromial area	Baseline
Secondary	PPT	Pressure Pain Threshold in subacromial area	After 3 weeks
Secondary	European Quality ol life - 5 dimensions (EQ-5D)	Higher scores mean a better outcome	Baseline
Secondary	European Quality ol life - 5 dimensions (EQ-5D)	Higher scores mean a better outcome	After 3 weeks
Secondary	European Quality ol life - 5 dimensions (EQ-5D)	Higher scores mean a better outcome	1 month after the end of the intervention
Secondary	European Quality ol life - 5 dimensions (EQ-5D)	Higher scores mean a better outcome	3 months after the end of the intervention