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TrueRelief Efficacy for Supraspinatus Tendonitis

Primary Purpose

Supraspinatus Tendinitis, Shoulder Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TrueRelief device
Sham TrueRelief device
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Supraspinatus Tendinitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Placebo

Experimental

Arm Description

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.

Patients receive an experimental procedure using a TrueRelief device.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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)

Full Information

First Posted
December 22, 2021
Last Updated
June 29, 2023
Sponsor
Weill Medical College of Cornell University
Collaborators
TrueRelief, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05184985
Brief Title
TrueRelief Efficacy for Supraspinatus Tendonitis
Official Title
Efficacy of TrueRelief as a Non-Pharmacological Alternative for Pain Relief in Supraspinatus Tendonitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
The study was closed due to recruitment challenges. The study design involved frequent visits 3 times a week for 3 consecutive weeks which many prospective participants were not able to commit to.
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
TrueRelief, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supraspinatus Tendinitis, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients receive an experimental procedure using a TrueRelief device.
Intervention Type
Device
Intervention Name(s)
TrueRelief device
Intervention Description
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
Intervention Name(s)
Sham TrueRelief device
Intervention Description
The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Primary Outcome Measure Information:
Title
Change in pain measurements in patients with Supraspinatus Tendonitis (SST).
Description
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.
Time Frame
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 Measure Information:
Title
Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST).
Description
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).
Time Frame
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)
Title
Change in perceived shoulder function as measured by a Shoulder Rating Questionnaire in patients with Supraspinatus Tendonitis (SST).
Description
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)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandana Sood, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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TrueRelief Efficacy for Supraspinatus Tendonitis

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