Chronic Shoulder PainNCT04245969

Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain

A study testing Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus in people with Chronic Shoulder Pain, run by University of Malaga.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated. Current studies show promising results in different musculoskeletal disorders, however further studies with proper designs and conclusive findings are… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Shoulder Pain
What is being tested?: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: No sites listed yet
Study dates: 30 Mar 2020to 31 Dec 2020
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To suffer from shoulder pain more than three months.
Men or women aged between 18 to 65 years;
Unilateral pain located in the anterior and/or lateral shoulder region;
2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
Pain with normal activity ≥ 4/10 on a visual analogue scale;
Nontraumatic onset of shoulder pain.

Who cannot join

History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
Recent shoulder dislocation in the past two years
Systemic illnesses such as rheumatoid arthritis
Adhesive capsulitis of the shoulder
Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.

About this study

Official title: Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial

Read the detailed description

Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers. Many factors have been proposed as the cause of pain, however it is still controversial and the same regarding the best treatment option.

Treatments throw different techniques have been investigated, showing a variety of results in terms of pain and sensitivity. However, the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment is to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the shoulder will produce better outcomes in terms of ultrasound assessment, strength, pain, sensitivity and range of movement, when compared to traditional methods used like manual therapy and/or exercise.

The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

The outcome measures will be electromyography and dynamometry to measure strength and muscular activity. The movements required to the patient will be shoulder flexion, abduction, adduction, and extension.

To quantify sensitivity, pain pressure thresholds will be measured throw an algometer placed on the coracoid process, on the lateral area of the shoulder (two centimeters below the acromion and on the acromioclavicular joint).

To measure the range of movement, a goniometer will be used for both glenohumeral and scapular rotations.

To measure quality of life and psychological factors several questionnaires will be asked (Pain catastrophizing scale, Pain vigilance and awareness questionnaire, Self-efficacy, SPADI, Tampa Scale-11, McGill)

Conditions: Chronic Shoulder Pain
Being tested: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus, Sham comparator, No intervention

What participants receive

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

Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulusDevice
448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area
Sham comparatorOther
A simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.
No interventionOther
These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.

Study groups in NCT04245969
Study group	Role	What they receive
INTERVENTION	Experimental	448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder Receives: Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus
Placebo Monopolar Radiofrequency stimulus	Experimental	To simulate the application of Monopolar Radiofrequency stimulus on the affected shoulder Receives: Other: Sham comparator
No intervention group	Experimental	To evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency. Receives: Other: No intervention

What is being measured

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

Change from Baseline ultrasound imaging at 3 months
Elastography
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from Baseline ultrasound imaging at 3 months
Tendon thickness
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Secondary outcomes (8)

Electromyography
Electromyography of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from Baseline dynamometry at 3 months
Strength of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Algometry
Pain pressure thresholds of different shoulder muscles (deltoid, trapezius,serratus )will be measured
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Range of movement
Measurement of mobility in different planes:
Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Catastrophizing Scale questionnaire
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Heart rate variability (HRV)
Measurement of Autonomic nervous system activity:
Resting HRV provides quantitative information regarding cardiac autonomic tone.
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Autonomic Symptom Profile questionnaire (ASP)
Measurement of Autonomic nervous system activity:
The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score
Measured: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Timeline

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

30 Mar 202031 Dec 2020

First posted29 Jan 2020
Study start30 Mar 2020 (estimated)
Primary completion30 May 2020 (estimated)
Study completion31 Dec 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Shoulder PainStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04245969
Sponsor's protocol ID: CRMRFSP
Status last verified: Jan 2020
First submitted: 15 Oct 2019
Last updated: 29 Jan 2020
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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?

Official record

RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Recruiting
Effects of Rotator Cuff Drills Versus Progressive Resistance Exercises on Chronic Rotator Cuff Tendinopathy
Rotator Cuff Tendinosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Active, not recruiting
Precision Medicine for Nociception, Sngception and Proprioception.
Rehabilitation, Pain, Shoulder

All Chronic Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial
ClinicalTrials.gov ID: NCT04245969
Acronym / sponsor ID: CRMRFSP
Conditions: Chronic Shoulder Pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: University of MalagaUniversity, hospital or other
Study start: 30 Mar 2020 (estimated)
Primary completion: 30 May 2020 (estimated)
Study completion: 31 Dec 2020 (estimated)
First posted: 29 Jan 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.

Detailed description

To measure the range of movement, a goniometer will be used for both glenohumeral and scapular rotations.

Study design

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

Arm	Type	Receives
INTERVENTION	Experimental	Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder
Placebo Monopolar Radiofrequency stimulus	Experimental	Other: Sham comparatorTo simulate the application of Monopolar Radiofrequency stimulus on the affected shoulder
No intervention group	Experimental	Other: No interventionTo evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

To suffer from shoulder pain more than three months.
Men or women aged between 18 to 65 years;
Unilateral pain located in the anterior and/or lateral shoulder region;
2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
Pain with normal activity ≥ 4/10 on a visual analogue scale;

Key exclusion criteria (5 listed)

History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
Recent shoulder dislocation in the past two years
Systemic illnesses such as rheumatoid arthritis
Adhesive capsulitis of the shoulder
Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.

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
Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area	Device	INTERVENTION
Sham comparatorA simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.	Other	Placebo Monopolar Radiofrequency stimulus
No interventionThese participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.	Other	No intervention group

Primary outcome

Change from Baseline ultrasound imaging at 3 months
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Elastography
Change from Baseline ultrasound imaging at 3 months
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Tendon thickness

8 secondary outcomes

Electromyography
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from Baseline dynamometry at 3 months
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Algometry
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Range of movement
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Catastrophizing Scale questionnaire
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Heart rate variability (HRV)
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Autonomic Symptom Profile questionnaire (ASP)
Time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
Individual participant dataSharing planned: No

Related trials for Chronic Shoulder Pain

RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Recruiting
Effects of Rotator Cuff Drills Versus Progressive Resistance Exercises on Chronic Rotator Cuff Tendinopathy
Rotator Cuff Tendinosis
RecruitingObservational study
Prospective Case Series Evaluating 6-Month and 12-Month Outcomes After Cryoneurolysis for Chronic Pain
Chronic Pain, PERIPHERAL NEUROPATHY
Active, not recruiting
Precision Medicine for Nociception, Sngception and Proprioception.
Rehabilitation, Pain, Shoulder

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus in people with Chronic Shoulder Pain, run by University of Malaga.

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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Results are not available in the source record.

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?

Change from Baseline ultrasound imaging at 3 months (time frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)). The study lists 2 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 NCT04245969.

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 29 Jan 2020.