search
Back to results

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

Primary Purpose

Shoulder Impingement Syndrome, Subacromial Impingement Syndrome

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Sham stimulation
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hospital General Universitario Nuestra Señora del Prado

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Thermal CRMRF

Subthermal CRMRF

Sham CRMRF

Arm Description

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

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).

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).

Outcomes

Primary Outcome Measures

Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
SPADI
Shoulder Pain and Disabilty Index
SPADI
Shoulder Pain and Disabilty Index
SPADI
Shoulder Pain and Disabilty Index
SPADI
Shoulder Pain and Disabilty Index

Secondary Outcome Measures

Quick DASH
Abbreviated
Quick DASH
Abbreviated
Quick DASH
Abbreviated
Quick DASH
Abbreviated
PPT
Pressure Pain Threshold in subacromial area
PPT
Pressure Pain Threshold in subacromial area
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome

Full Information

First Posted
January 29, 2020
Last Updated
September 23, 2021
Sponsor
University of Castilla-La Mancha
Collaborators
Hospital General Nuestra Señora del Prado, Castilla-La Mancha Health Service, Indiba S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT04255186
Brief Title
Treatment Using 448 kHz CRMRF in Subacromial Syndrome.
Acronym
CRMRF
Official Title
Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
September 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Castilla-La Mancha
Collaborators
Hospital General Nuestra Señora del Prado, Castilla-La Mancha Health Service, Indiba S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome, Subacromial Impingement Syndrome
Keywords
shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermal CRMRF
Arm Type
Experimental
Arm Description
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
Arm Title
Subthermal CRMRF
Arm Type
Experimental
Arm Description
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).
Arm Title
Sham CRMRF
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Other Intervention Name(s)
CRMRF
Intervention Description
Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Intervention Type
Device
Intervention Name(s)
Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Intervention Description
Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Intervention Type
Device
Intervention Name(s)
Sham stimulation
Intervention Description
a simulated stimulation protocol so that the device does not emit current
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
minimun 0 - maximun10. Higher scores mean a worse outcome
Time Frame
Baseline
Title
Visual Analogue Scale
Description
minimun 0 - maximun10. Higher scores mean a worse outcome
Time Frame
After 3 weeks
Title
Visual Analogue Scale
Description
minimun 0 - maximun10. Higher scores mean a worse outcome
Time Frame
1 month after the end of the intervention
Title
Visual Analogue Scale
Description
minimun 0 - maximun10. Higher scores mean a worse outcome
Time Frame
3 months after the end of the intervention
Title
SPADI
Description
Shoulder Pain and Disabilty Index
Time Frame
Baseline
Title
SPADI
Description
Shoulder Pain and Disabilty Index
Time Frame
After 3 weeks
Title
SPADI
Description
Shoulder Pain and Disabilty Index
Time Frame
1 month after the end of the intervention
Title
SPADI
Description
Shoulder Pain and Disabilty Index
Time Frame
3 months after the end of the intervention
Secondary Outcome Measure Information:
Title
Quick DASH
Description
Abbreviated
Time Frame
Baseline
Title
Quick DASH
Description
Abbreviated
Time Frame
After 3 weeks
Title
Quick DASH
Description
Abbreviated
Time Frame
1 month after the end of the intervention
Title
Quick DASH
Description
Abbreviated
Time Frame
3 months after the end of the intervention
Title
PPT
Description
Pressure Pain Threshold in subacromial area
Time Frame
Baseline
Title
PPT
Description
Pressure Pain Threshold in subacromial area
Time Frame
After 3 weeks
Title
European Quality ol life - 5 dimensions (EQ-5D)
Description
Higher scores mean a better outcome
Time Frame
Baseline
Title
European Quality ol life - 5 dimensions (EQ-5D)
Description
Higher scores mean a better outcome
Time Frame
After 3 weeks
Title
European Quality ol life - 5 dimensions (EQ-5D)
Description
Higher scores mean a better outcome
Time Frame
1 month after the end of the intervention
Title
European Quality ol life - 5 dimensions (EQ-5D)
Description
Higher scores mean a better outcome
Time Frame
3 months after the end of the intervention
Other Pre-specified Outcome Measures:
Title
Medication intake
Description
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time Frame
Baseline
Title
Medication intake
Description
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time Frame
After 3 weeks
Title
Medication intake
Description
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time Frame
1 month after the end of the intervention
Title
Medication intake
Description
Analgesic ladder for chronic pain. Higher scores mean a worse outcome
Time Frame
3 months after the end of the intervention
Title
Blinding assesment
Description
The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.
Time Frame
After three weeks
Title
Blinding assesment
Description
The patient, the external evaluator, the therapist who applies radiofrequency and the kinesitherapist physiotherapist will be asked about the patient's group of belonging.
Time Frame
3 months after the end of the intervention
Title
Total number of sessions of the exercise protocol for discharge
Description
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.
Time Frame
3 months after the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Avendaño-Coy, PhD
Organizational Affiliation
Castilla La Mancha University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Javier Aceituno-Gómez, PhD
Organizational Affiliation
Castilla-La Mancha Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital General Universitario Nuestra Señora del Prado
City
Talavera de la Reina
State/Province
Toledo
ZIP/Postal Code
45600
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

We'll reach out to this number within 24 hrs