Clinical trial NCT04255186: Treatment Using 448 kHz CRMRF in Subacromial Syndrome.
Official title: Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Impingement Syndrome
Subacromial Impingement Syndrome
Keywords: shoulder pain
shoulder impingement syndrome
radiofrequency treatment
electrophysical agents
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
Collaborators: name: Hospital General Nuestra Señora del Prado
name: Castilla-La Mancha Health Service
name: Indiba S.A.
First posted: 2020-02-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline
measure: Visual Analogue Scale
timeFrame: After 3 weeks
measure: Visual Analogue Scale
timeFrame: 1 month after the end of the intervention
measure: Visual Analogue Scale
timeFrame: 3 months after the end of the intervention
measure: SPADI
timeFrame: Baseline
measure: SPADI
timeFrame: After 3 weeks
measure: SPADI
timeFrame: 1 month after the end of the intervention
measure: SPADI
timeFrame: 3 months after the end of the intervention
Secondary outcomes:
measure: Quick DASH
timeFrame: Baseline
measure: Quick DASH
timeFrame: After 3 weeks
measure: Quick DASH
timeFrame: 1 month after the end of the intervention
measure: Quick DASH
timeFrame: 3 months after the end of the intervention
measure: PPT
timeFrame: Baseline
measure: PPT
timeFrame: After 3 weeks
measure: European Quality ol life - 5 dimensions (EQ-5D)
timeFrame: Baseline
measure: European Quality ol life - 5 dimensions (EQ-5D)
timeFrame: After 3 weeks
measure: European Quality ol life - 5 dimensions (EQ-5D)
timeFrame: 1 month after the end of the intervention
measure: European Quality ol life - 5 dimensions (EQ-5D)
timeFrame: 3 months after the end of the intervention
Other outcomes:
measure: Medication intake
timeFrame: Baseline
measure: Medication intake
timeFrame: After 3 weeks
measure: Medication intake
timeFrame: 1 month after the end of the intervention
measure: Medication intake
timeFrame: 3 months after the end of the intervention
measure: Blinding assesment
timeFrame: After three weeks
measure: Blinding assesment
timeFrame: 3 months after the end of the intervention
measure: Total number of sessions of the exercise protocol for discharge
timeFrame: 3 months after the end of the intervention
Locations:
city: Talavera de la Reina
country: Spain
facility: Hospital General Universitario Nuestra Señora del Prado
state: Toledo
Study officials:
affiliation: Castilla La Mancha University
name: Juan Avendaño-Coy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Castilla-La Mancha Health Service
name: Javier Aceituno-Gómez, PhD
role: PRINCIPAL_INVESTIGATOR
References: