TrueRelief Efficacy for Supraspinatus Tendonitis

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Shoulder Pain; Supraspinatus Tendinitis

Treatments: Device: TrueRelief device; Device: Sham TrueRelief device

Study type: Interventional

Funder types: Other

Identifiers

NCT05184985

21-01023230

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Placebo

Sham Comparator group

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.

Treatment:

Device: Sham TrueRelief device

Experimental

Experimental group

Description:

Patients receive an experimental procedure using a TrueRelief device.

Treatment:

Device: TrueRelief device