TrueRelief Efficacy for Supraspinatus Tendonitis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Supraspinatus Tendinitis, Shoulder Pain

Intervention / Treatment
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* Device: TrueRelief device
* Device: Sham TrueRelief device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Triple


Arms and Interventions

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

What is the study measuring?
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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) |