TrueRelief Efficacy for Supraspinatus Tendonitis

NCT ID: NCT05184985

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2023-06-30

Brief Summary

The investigators hypothesize that TrueRelief will result in improved outcomes for patients with shoulder pain compared to those receiving the sham TrueRelief treatment. Also, it is likely that those with fewer medical comorbidities will experience the greatest improvement.

Detailed Description

Supraspinatus tendonitis (SST) is a common source of shoulder pain that primary care, sports medicine, and orthopedic surgeons regularly manage. TrueRelief's FDA-cleared device, called TrueRelief 1250, is a noninvasive technology that provides pain relief through the delivery of high frequency pulsed direct electrical current to the skin surface around the location of the tendonitis via anode and cathode probes. This study will assess if TrueRelief may be an effective option in treating SST, given the preliminary data surrounding its anti-inflammatory and subsequent analgesic properties. The investigators are proposing the first double-blind, randomized, sham-controlled study of TrueRelief to determine a more accurate measurement of its efficacy, specifically in patients with SST. The investigators hypothesize that TrueRelief will result in improved outcomes in this patient population compared to those receiving the sham TrueRelief treatment.

Conditions

Supraspinatus Tendinitis; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Patients receive a placebo procedure using a sham TrueRelief device that looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Group Type: SHAM_COMPARATOR

Sham TrueRelief device

Intervention Type: DEVICE

The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Experimental

Patients receive an experimental procedure using a TrueRelief device.

Group Type: EXPERIMENTAL

TrueRelief device

Intervention Type: DEVICE

TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.

Interventions

TrueRelief device

TrueRelief is an FDA-cleared treatment for chronic intractable pain, and as an adjunctive procedure in the management of post-surgical and post-traumatic acute pain. This 20,000 Hz high frequency electrical procedure is provided by clinicians trained in the use of the device and delivered via handheld steel-tipped probes to the source of pain and where pain is experienced.

Intervention Type: DEVICE

Sham TrueRelief device

The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Those with shoulder pain of recent onset (<3 months)

Exclusion Criteria

• Those whose physical examination meets either criteria below:

• Positive impingement tests
• At least two of:

• Jobe
• Modified Jobe
• Hawkins-Kennedy
• Neer
• Painful arc:
• Painful arc at 70-120 degrees abduction and/or
• Painful arc at 70-120 degrees flexion
• Pain with resisted abduction and/or external rotation
• Those between the ages of 18 and 65
• Those willing and able to sign consent

• Those who have had ipsilateral shoulder surgery involving the supraspinatus muscle
• Those who have experienced a fracture or avulsion fracture of any element of the shoulder or forequarter area (rib cage, clavicle, or humerus)
• Those with full-thickness rotator cuff tear
• Those with a long head of biceps rupture
• Those with shoulder pathology other than SST (ex: glenohumeral joint (GHJ) arthritis, adhesive capsulitis, labral tear). However, ACJ arthritis can be admitted since this is a very common comorbidity.
• Those with comorbidities that may confound the outcome, such as:

• Diabetes (either type I or type II)
• Auto-inflammatory diseases
• Auto-immune diseases
• Connective tissue disorders (Ehlers Danlos Syndrome)
• Those with demand type pacemakers
• Pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TrueRelief, LLC

INDUSTRY

Sponsor Role: collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vandana Sood, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine

New York, New York, United States

Countries

United States

Other Identifiers

21-01023230

Identifier Type: -

Identifier Source: org_study_id