TrueRelief Efficacy for Supraspinatus Tendonitis

Efficacy of TrueRelief as a Non-Pharmacological Alternative for Pain Relief in Supraspinatus Tendonitis

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.

Study Overview

• Status: Withdrawn
• Conditions: Shoulder Pain; Supraspinatus Tendinitis
• Intervention / Treatment: Device: TrueRelief device; Device: Sham TrueRelief device

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Those with shoulder pain of recent onset (<3 months)
• Those with supraspinatus tendonitis only (see exclusion criteria below)

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: 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.	Device: Sham TrueRelief device; The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Experimental: Experimental; Patients receive an experimental procedure using a TrueRelief device.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST).	An assessment of the effect of TrueRelief on perceived function in patients with SST will be done through a QuickDASH questionnaire. This questionnaire will be administered at baseline, midpoint and at the end of the study treatment, as well as during the 1-month post-treatment follow-up phone call. The quickDASH questionnaire will be scored on a scale ranging from 0 (no disability) to 100 (most severe disability).	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).	An assessment of the effect of TrueRelief on perceived function in patients with SST will be done through a Shoulder Rating questionnaire. This questionnaire will be administered at baseline, midpoint and at the end of the study treatment, as well as during the 1-month post-treatment follow-up phone call. A total weighted score will be calculated based on the answers to the Shoulder Rating Questionnaire, with values ranging from 0 (less severe condition of shoulder) to 100 (more severe condition of shoulder)	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)

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: TrueRelief, LLC
• Investigators: Principal Investigator: Vandana Sood, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Estimated): June 1, 2023
• Study Completion (Estimated): June 1, 2023

Study Registration Dates

• First Submitted: December 22, 2021
• First Submitted That Met QC Criteria: December 22, 2021
• First Posted (Actual): January 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Rupture; Shoulder Injuries; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Tendinopathy; Shoulder Pain
• Other Study ID Numbers: 21-01023230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes