Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
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 chronic pain from subacromial impingement syndrome (SIS) will fail
 treatment efforts and have longstanding pain. This project will evaluate the efficacy of a
 novel approach to treatment, percutaneous peripheral nerve stimulation, for participants with
 chronic shoulder pain due to subacromial impingement syndrome (SIS).
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 common cause is subacromial impingement syndrome (SIS), which accounts for 30% of
 all shoulder pain. Approximately 35% of patients who present with subacromial impingement
 syndrome (SIS) are refractory to conservative management. For patients who have failed
 conservative management, there are no established treatments to reduce the pain. The
 long-term goal is to develop a therapeutic intervention to reduce pain related to subacromial
 impingement syndrome(SIS). A pilot trial of 3-week percutaneous peripheral nerve stimulation
 (PNS) for participants with chronic shoulder pain due to subacromial impingement syndrome
 (SIS) that was refractory to conservative treatment that showed 60% of participants had
 successful treatment of pain that lasted at least 3 months. Thus, the primary objective of
 this 2 site randomized control trial (RCT) is to confirm the findings of this preliminary
 trial and determine the efficacy of peripheral nerve stimulation (PNS) for chronic
 subacromial impingement syndrome (SIS). The secondary objectives of this multisite randomized
 control trial (RCT) is to explore mechanisms of peripheral nerve stimulation (PNS) for the
 treatment of subacromial impingement syndrome (SIS), and to determine which characteristics
 can predict successful treatment with peripheral nerve stimulation (PNS). In order to
 accomplish these objectives, this trial is a multi-site, placebo controlled, double-blinded
 randomized control trial (RCT) to compare the efficacy of peripheral nerve stimulation (PNS)
 to sham peripheral nerve stimulation (PNS). Measures of pain, pain interference with
 activities of daily living (ADLs), capacity for activities of daily living (ADLs), Quality of
 life (QoL), and measures of central sensitization (pain thresholds, secondary hyperalgesia,
 and temporal summation) will be measured. Participants will be followed for a total of 24
 weeks after treatment has concluded.
Inclusion Criteria:

 1. Shoulder pain of >3 months

 2. Age>=21

 3. Worst pain in the last week>=4 (0-10 scale)

 4. Ability to check skin and perform dressing changes, independently or with assistance

 5. Stable dose of pain medication (Not taking more than than 1 opioid or 1 non-opioid
 analgesic)

 Exclusion Criteria:

 1. Current shoulder joint or overlying skin infection, or current bacterial infection
 requiring antibiotics

 2. 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)

 3. Prior shoulder surgery to ipsilateral shoulder joint (glenohumeral, rotator cuff,
 acromioclavicular (AC) Joint, etc.)

 4. Corticosteroid injection in the ipsilateral shoulder or any other pain relieving
 treatment in last 12 weeks

 5. Uncontrolled bleeding disorder

 6. Medical instability based on physician opinion after review of medical information

 7. Pregnancy

 8. Neurological condition affecting ipsilateral upper limb (such as central neurologic
 injury/illness, radiculopathy, diabetic amyotrophy, Complex Regional Pain Syndrome,
 etc.)

 9. Current Worker's compensation claim for the ipsilateral shoulder

 10. Shoulder instability, severe glenohumeral osteoarthritis(OA) based on patient symptoms
 and physical examination

 11. 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))

 12. Current osseus fracture in ipsilateral arm

 13. Ipsilateral upper limb amputation other than a single digit (digits 2-5, partial or
 full)

 14. Surgical indication for shoulder treatment based on physician opinion

 15. Compromised immune system (immunodeficiency or immunosuppression)

 16. 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

 17. Patients who have a tape or adhesive allergy

 18. Contraindication to Magnetic resonance imaging (metal in body, claustrophobia, body
 habitus, etc) - exclude from Magnetic resonance imaging (MRI) only