Clinical trial NCT05184985: TrueRelief Efficacy for Supraspinatus Tendonitis
Official title: Efficacy of TrueRelief as a Non-Pharmacological Alternative for Pain Relief in Supraspinatus Tendonitis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Supraspinatus Tendinitis
Shoulder Pain
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: TrueRelief, LLC
First posted: 2022-01-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain measurements in patients with Supraspinatus Tendonitis (SST).
timeFrame: 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:
measure: Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST).
timeFrame: 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)
measure: Change in perceived shoulder function as measured by a Shoulder Rating Questionnaire in patients with Supraspinatus Tendonitis (SST).
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian/Weill Cornell Medical Center Rehabilitation Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Vandana Sood, MD
role: PRINCIPAL_INVESTIGATOR
References: