N/A
N=116
Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Shoulder Pain · Shoulder Impingement Syndrome · Shoulder Tendinitis · Shoulder Bursitis · Pain, Shoulder
Bottom Line
View on ClinicalTrials.gov: NCT03752619 ↗Enrolled (actual)
116
Serious AEs
6.0%
Results posted
Feb 2025
Primary outcome: Primary: Change in - Short Form (SF) Question 3 (BPI-SF3) — 6.90; 7.05; 3.58; 3.96 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contracting Producing Peripheral Nerve Stimulation (Device); Non Contracting Producing Peripheral Nerve Stimulation (Device); Physical Therapy (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Jun 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in - Short Form (SF) Question 3 (BPI-SF3) |
6.90; 7.05; 3.58; 3.96; 3.51; 3.53 | — |
| SECONDARY Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) |
105.76; 129.95; 146.96; 168.32; 140.33; 175.31 | — |
| SECONDARY Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI) |
48.97; 41.30; 25.78; 21.76; 23.52; 18.88 | — |
| SECONDARY Change in Quality of Life - Short Form - 12(QoL - SF 12) |
38.43; 39.72; 44.67; 45.85; 45.63; 46.39 | — |
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 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).
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03752619). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.