Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

NCT ID: NCT04255186

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-03
• Study Completion Date: 2021-09-15

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.

Conditions

Shoulder Impingement Syndrome; Subacromial Impingement Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Intervention Type: DEVICE

Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

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).

Group Type: EXPERIMENTAL

Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Intervention Type: DEVICE

Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

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).

Group Type: SHAM_COMPARATOR

Sham stimulation

Intervention Type: DEVICE

a simulated stimulation protocol so that the device does not emit current

Interventions

Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

Intervention Type: DEVICE

Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency

Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method

Intervention Type: DEVICE

Sham stimulation

a simulated stimulation protocol so that the device does not emit current

Intervention Type: DEVICE

Other Intervention Names

CRMRF

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital General Nuestra Señora del Prado

OTHER

Sponsor Role: collaborator

Castilla-La Mancha Health Service

OTHER

Sponsor Role: collaborator

Indiba S.A.

UNKNOWN

Sponsor Role: collaborator

University of Castilla-La Mancha

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Avendaño-Coy, PhD

Role: PRINCIPAL_INVESTIGATOR

Castilla La Mancha University

Javier Aceituno-Gómez, PhD

Role: PRINCIPAL_INVESTIGATOR

Castilla-La Mancha Health Service

Locations

Hospital General Universitario Nuestra Señora del Prado

Talavera de la Reina, Toledo, Spain

Countries

Spain

Other Identifiers

448 kHz CRMRF UCLM

Identifier Type: -

Identifier Source: org_study_id