Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

NCT04255186 | Completed

• 1 other identifier: 448 kHz CRMRF UCLM
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Impingement Syndrome; Subacromial Impingement Syndrome

Keywords

shoulder pain; shoulder impingement syndrome; radiofrequency treatment; electrophysical agents

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (10)

• Quick DASH

  Baseline

• Quick DASH

  After 3 weeks

• Quick DASH

  1 month after the end of the intervention

• Quick DASH

  3 months after the end of the intervention

• PPT

  Baseline

Other Outcomes (7)

• Medication intake

  Baseline

• Medication intake

  After 3 weeks

• Medication intake

  1 month after the end of the intervention

Study Arms (3)

Thermal CRMRF

EXPERIMENTAL

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

Subthermal CRMRF

EXPERIMENTAL

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

Sham CRMRF

SHAM COMPARATOR

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

Interventions

Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency DEVICE

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

Also known as: CRMRF

Thermal CRMRF

Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency DEVICE

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

Subthermal CRMRF

Sham stimulation DEVICE

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

Sham CRMRF

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Castilla-La Mancha: lead
• Hospital General Nuestra Señora del Prado: collaborator
• Castilla-La Mancha Health Service: collaborator
• Indiba S.A.: collaborator

Study Sites (1)

Hospital General Universitario Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Shoulder Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Juan Avendaño-Coy, PhD

  Castilla La Mancha University

  PRINCIPAL INVESTIGATOR

• Javier Aceituno-Gómez, PhD

  Castilla-La Mancha Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: February 5, 2020
• Study Start: February 3, 2020
• Primary Completion: September 15, 2021
• Study Completion: September 15, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Locations

ES (1)