Status:
COMPLETED
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Lead Sponsor:
MetroHealth Medical Center
Collaborating Sponsors:
University of Texas
Conditions:
Shoulder Pain
Shoulder Impingement Syndrome
Eligibility:
All Genders
21-100 years
Phase:
NA
Brief Summary
Shoulder pain accounts for 16% of all musculoskeletal complaints in the healthy adult population. Subacromial impingement syndrome (SIS) is the most common cause of shoulder pain. Many patients with c...
Detailed Description
The medical and socioeconomic impact of subacute and chronic shoulder pain is high, resulting in 12 million visits to physicians and over $7 billion in direct costs in the United States. The most comm...
Eligibility Criteria
Inclusion
- Shoulder pain of \>3 months
- Age\>=21
- Worst pain in the last week\>=4 (0-10 scale)
- Ability to check skin and perform dressing changes, independently or with assistance
- Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid analgesic)
Exclusion
- Current shoulder joint or overlying skin infection, or current bacterial infection requiring antibiotics
- Other chronic pain syndrome (Pain in another area of the body 15 or more days in the last 30 (more than half of the time) or taking daily analgesics for another pain syndrome)
- Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff, acromioclavicular (AC) Joint, etc.)
- Corticosteroid injection in the ipsilateral shoulder or any other pain relieving treatment in last 12 weeks
- Uncontrolled bleeding disorder
- Medical instability based on physician opinion after review of medical information
- Pregnancy
- Neurological condition affecting ipsilateral upper limb (such as central neurologic injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome, etc.)
- Current Worker's compensation claim for the ipsilateral shoulder
- Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms and physical examination
- Ipsilateral shoulder injury due to severe trauma (Fall from greater than standing height; Motor vehicle crashes; Struck by vehicle or other fast-moving projectile (e.g., bullet, baseball, etc.); Assault (i.e., injuries intentionally inflicted by another person))
- Current osseus fracture in ipsilateral arm
- Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or full)
- Surgical indication for shoulder treatment based on physician opinion
- Compromised immune system (immunodeficiency or immunosuppression)
- Current use of a Deep Brain Stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), any other implantable neuro-stimulator whose stimulus current pathway may overlap with that of the SPRINT System
- Patients who have a tape or adhesive allergy
- Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body habitus, etc) - exclude from Magnetic resonance imaging (MRI) only
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03752619
Start Date
March 1 2019
End Date
June 21 2024
Last Update
June 17 2025
Active Locations (2)
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1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
2
Univerity of Texas Southwestern
Dallas, Texas, United States, 75390