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

NCT04245969 | Unknown DMC

• 1 other identifier: CRMRFSP
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 necessary.

Conditions

Chronic Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• Change from Baseline ultrasound imaging at 3 months

  Elastography

  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

  time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Secondary Outcomes (8)

• Electromyography

  time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

• Change from Baseline dynamometry at 3 months

  time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

• Algometry

  time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

• Range of movement

  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 (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Study Arms (3)

INTERVENTION

EXPERIMENTAL

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder

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

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.

Other: No intervention

Interventions

Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus DEVICE

448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area

INTERVENTION

Sham comparator OTHER

A simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.

Placebo Monopolar Radiofrequency stimulus

No intervention OTHER

These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.

No intervention group

Eligibility Criteria

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

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY PROFESSOR

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: January 29, 2020
• Study Start: March 30, 2020
• Primary Completion: May 30, 2020
• Study Completion: December 31, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share