Shoulder Impingement SyndromeCRMRFNCT04255186

Treatment Using 448 kHz CRMRF in Subacromial Syndrome.

A study testing Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency and Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency in people with Shoulder Impingement Syndrome and Subacromial Impingement Syndrome, run by University of Castilla-La Mancha at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Shoulder Impingement Syndrome, Subacromial Impingement Syndrome
What is being tested?: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency and Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 1 siteSpain
Study dates: 3 Feb 2020to 15 Sep 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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:

Show all 10Show fewer

Pacemaker
Thrombophlebitis
Pregnancy
Skin disorders (recent wounds or burns)

Trial locations and contacts

1 site in 1 country.

Spain1 site

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

Other trials in Spain

About this study

Official title: 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.

Read the 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
Being tested: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency, Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency, Sham stimulation
Keywords: shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents
Medical subject headings: Shoulder Impingement Syndrome, Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Thermal 448 kHz Capacitive Resistive Monopolar RadiofrequencyDevice
Also called CRMRF
Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Subthermal 448 kHz Capacitive Resistive Monopolar RadiofrequencyDevice
Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
Sham stimulationDevice
a simulated stimulation protocol so that the device does not emit current

Study groups in NCT04255186
Study group	Role	What they receive
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 Receives: 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). Receives: 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). Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Measured: Baseline
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Measured: After 3 weeks
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Measured: 1 month after the end of the intervention
Visual Analogue Scale
minimun 0 - maximun10. Higher scores mean a worse outcome
Measured: 3 months after the end of the intervention
SPADI
Shoulder Pain and Disabilty Index
Measured: Baseline
SPADI
Shoulder Pain and Disabilty Index
Measured: After 3 weeks
SPADI
Shoulder Pain and Disabilty Index
Measured: 1 month after the end of the intervention
SPADI
Shoulder Pain and Disabilty Index
Measured: 3 months after the end of the intervention

Secondary outcomes (10)

Quick DASH
Abbreviated
Measured: Baseline
Quick DASH
Abbreviated
Measured: After 3 weeks
Quick DASH
Abbreviated
Measured: 1 month after the end of the intervention
Quick DASH
Abbreviated
Measured: 3 months after the end of the intervention
PPT
Pressure Pain Threshold in subacromial area
Measured: Baseline
PPT
Pressure Pain Threshold in subacromial area
Measured: After 3 weeks
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
Measured: Baseline
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
Measured: After 3 weeks
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
Measured: 1 month after the end of the intervention
European Quality ol life - 5 dimensions (EQ-5D)
Higher scores mean a better outcome
Measured: 3 months after the end of the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Feb 202015 Sep 2021

First posted5 Feb 2020
Study start3 Feb 2020
Primary completion15 Sep 2021
Study completion15 Sep 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04255186
Sponsor's protocol ID: 448 kHz CRMRF UCLM
Acronym: CRMRF
Status last verified: Sep 2021
First submitted: 29 Jan 2020
Last updated: 30 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

All Shoulder Impingement Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Using 448 kHz Capacitive Resistive Monopolar Radiofrequency in Patients With Subacromial Syndrome. A Randomised Controlled Trial.
ClinicalTrials.gov ID: NCT04255186
Acronym / sponsor ID: CRMRF / 448 kHz CRMRF UCLM
Conditions: Shoulder Impingement Syndrome, Subacromial Impingement Syndrome
Keywords: shoulder pain, shoulder impingement syndrome, radiofrequency treatment, electrophysical agents
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: University of Castilla-La ManchaUniversity, hospital or other
Collaborators: Hospital General Nuestra Señora del Prado, Castilla-La Mancha Health Service, Indiba S.A.
Study start: 3 Feb 2020 (actual)
Primary completion: 15 Sep 2021 (actual)
Study completion: 15 Sep 2021 (actual)
First posted: 5 Feb 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Thermal CRMRF	Experimental	Device: Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency9 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
Subthermal CRMRF	Experimental	Device: Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency9 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).
Sham CRMRF	Sham comparator	Device: Sham stimulation9 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).

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (10 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Thermal 448 kHz Capacitive Resistive Monopolar RadiofrequencyAlso: CRMRFThermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method	Device	Thermal CRMRF
Subthermal 448 kHz Capacitive Resistive Monopolar RadiofrequencySubthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method	Device	Subthermal CRMRF
Sham stimulationa simulated stimulation protocol so that the device does not emit current	Device	Sham CRMRF

Primary outcome

Visual Analogue Scale
Time frame: Baseline
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
Time frame: After 3 weeks
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
Time frame: 1 month after the end of the intervention
minimun 0 - maximun10. Higher scores mean a worse outcome
Visual Analogue Scale
Time frame: 3 months after the end of the intervention
minimun 0 - maximun10. Higher scores mean a worse outcome
SPADI
Time frame: Baseline
Shoulder Pain and Disabilty Index
SPADI
Time frame: After 3 weeks
Shoulder Pain and Disabilty Index
SPADI
Time frame: 1 month after the end of the intervention
Shoulder Pain and Disabilty Index
SPADI
Time frame: 3 months after the end of the intervention
Shoulder Pain and Disabilty Index

10 secondary outcomes

Quick DASH
Time frame: Baseline
Quick DASH
Time frame: After 3 weeks
Quick DASH
Time frame: 1 month after the end of the intervention
Quick DASH
Time frame: 3 months after the end of the intervention
PPT
Time frame: Baseline
PPT
Time frame: After 3 weeks
European Quality ol life - 5 dimensions (EQ-5D)
Time frame: Baseline
European Quality ol life - 5 dimensions (EQ-5D)
Time frame: After 3 weeks
European Quality ol life - 5 dimensions (EQ-5D)
Time frame: 1 month after the end of the intervention
European Quality ol life - 5 dimensions (EQ-5D)
Time frame: 3 months after the end of the intervention

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.

Related trials for Shoulder Impingement Syndrome

Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Recruiting
Device-Assisted Balance Training for People With Shoulder Impingement
Shoulder
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Spencer vs Positional Release Techniques for Chronic Subacromial Impingement
Chronic Subacromial Impingement Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Juan Avendaño-Coy, PhD principal investigator

Castilla La Mancha University

Javier Aceituno-Gómez, PhD principal investigator

Castilla-La Mancha Health Service

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Scale (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04255186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.