Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

Not Applicable

Completed

• Conditions: Subacromial Impingement Syndrome; Shoulder Impingement Syndrome
• Interventions: Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency; Device: Sham stimulation; Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

• Registration Number: NCT04255186
• Lead Sponsor: University of Castilla-La Mancha

Brief 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.

Study Timeline

• Study First Submitted: 2020-01-29
• Study First Submitted QC: 2020-02-02
• Study Start: 2020-02-03
• Study First Posted: 2020-02-05
• Status Verified: 2021-09
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subthermal CRMRF	Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency	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 stimulation	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).
Thermal CRMRF	Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency	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

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	3 months after the end of the intervention	minimun 0 - maximun10. Higher scores mean a worse outcome
SPADI	3 months after the end of the intervention	Shoulder Pain and Disabilty Index

Secondary Outcome Measures

Name	Time	Method
Quick DASH	3 months after the end of the intervention	Abbreviated
European Quality ol life - 5 dimensions (EQ-5D)	3 months after the end of the intervention	Higher scores mean a better outcome
PPT	After 3 weeks	Pressure Pain Threshold in subacromial area

Trial Locations

Locations (1)

Hospital General Universitario Nuestra Señora del Prado; 🇪🇸 Talavera de la Reina, Toledo, Spain