Shoulder Pain, Supraspinatus Tendinitis
Conditions
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.
Interventions
DEVICETrueRelief 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.
DEVICESham TrueRelief device
The placebo device looks and operates identically to the experimental TrueRelief device but will not emit any high frequency current.
Sponsors
TrueRelief, LLC
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain measurements in patients with Supraspinatus Tendonitis (SST). | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in perceived shoulder function as measured by QuickDASH Questionnaire in patients with Supraspinatus Tendonitis (SST). | 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) | 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). | 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) | 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) |
Countries
United States
Outcome results
None listed