Treatment Using 448 kHz CRMRF in Subacromial Syndrome. (CRMRF)

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

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

Study Overview

• Status: Completed
• Conditions: Subacromial Impingement Syndrome; Shoulder Impingement Syndrome
• Intervention / Treatment: Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency; Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency; Device: Sham stimulation

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 Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Toledo
    • Talavera de la Reina, Toledo, Spain, 45600
      • Hospital General Universitario Nuestra Señora del Prado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thermal CRMRF; 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	Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency; Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method; Other Names: CRMRF
Experimental: Subthermal CRMRF; 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).	Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency; Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Sham Comparator: Sham CRMRF; 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).	Device: Sham stimulation; a simulated stimulation protocol so that the device does not emit current

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick DASH	Abbreviated	Baseline
Quick DASH	Abbreviated	After 3 weeks
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

Other Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha
• Collaborators: Castilla-La Mancha Health Service; Hospital General Nuestra Señora del Prado; Indiba S.A.
• Investigators: Principal Investigator: Juan Avendaño-Coy, PhD, Castilla La Mancha University; Principal Investigator: Javier Aceituno-Gómez, PhD, Castilla-La Mancha Health Service

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: January 29, 2020
• First Submitted That Met QC Criteria: February 2, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): September 30, 2021
• Last Update Submitted That Met QC Criteria: September 23, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: shoulder pain; radiofrequency treatment; shoulder impingement syndrome; electrophysical agents
• Additional Relevant MeSH Terms: Pathologic Processes; Wounds and Injuries; Disease; Joint Diseases; Musculoskeletal Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Syndrome; Rotator Cuff Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: 448 kHz CRMRF UCLM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No