TrueRelief Efficacy for Supraspinatus Tendonitis

NCT05184985 | Withdrawn FDA Device

• 1 other identifier: 21-01023230
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Supraspinatus Tendinitis; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• Change in pain measurements in patients with Supraspinatus Tendonitis (SST).

  An assessment of the effect of TrueRelief on pain in patients with SST will be done by measuring pain at baseline, midpoint and at the end of the study treatment, as well as during the 1-month post-treatment follow-up phone call. Patients will be asked to rate their pain on a Visual Analog Pain Scale from 0 to 10, with 0 indicating no pain and 10 indicating emergency pain.

  Beginning of study (Visit 1 - Week 1), Midpoint of Study (Visit 5 - Week 2), End of study (Visit 9 - Week 3), 1-month post-treatment follow-up call (Week 7-9)

Secondary Outcomes (2)

• Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST).

  Beginning of study (Visit 1 - Week 1), Midpoint of Study (Visit 5 - Week 2), End of study (Visit 9 - Week 3), 1-month post-treatment follow-up call (Week 7-9)

• Change in perceived shoulder function as measured by a Shoulder Rating Questionnaire in patients with Supraspinatus Tendonitis (SST).

  Beginning of study (Visit 1 - Week 1), Midpoint of Study (Visit 5 - Week 2), End of study (Visit 9 - Week 3), 1-month post-treatment follow-up call (Week 7-9)

Study Arms (2)

Placebo

SHAM COMPARATOR

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.

Device: Sham TrueRelief device

Experimental

EXPERIMENTAL

Patients receive an experimental procedure using a TrueRelief device.

Device: TrueRelief device

Interventions

TrueRelief device 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.

Experimental

Sham TrueRelief device DEVICE

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

Placebo

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• TrueRelief, LLC: collaborator

Study Sites (1)

New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vandana Sood, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomized, sham-controlled trial parallel arm study using TrueRelief as the experimental treatment and a TrueRelief device with sham capabilities as a placebo.

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: May 4, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)