Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)

Not Applicable

Completed

Conditions: Shoulder Impingement Syndrome
Shoulder Tendinitis
Shoulder Pain
Shoulder Bursitis
Pain, Shoulder

Interventions: Device: Contracting Producing Peripheral Nerve Stimulation
Device: Non Contracting Producing Peripheral Nerve Stimulation
Other: Physical Therapy

Registration Number: NCT03752619

Lead Sponsor: MetroHealth Medical Center

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 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).

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 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 116

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Contraction Producing Peripheral Nerve Stimulation	Contracting Producing Peripheral Nerve Stimulation	This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
Contraction Producing Peripheral Nerve Stimulation	Physical Therapy	This group will receive: 1) muscle contraction producing peripheral nerve stimulation treatment (which will produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
Non Contracting Producing Peripheral Nerve Stimulation	Non Contracting Producing Peripheral Nerve Stimulation	This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.
Non Contracting Producing Peripheral Nerve Stimulation	Physical Therapy	This group will receive: 1) non contraction producing peripheral nerve stimulation treatment (which will not produce muscle contraction) for three weeks (6 hours daily); and, 2) physical therapy.

Primary Outcome Measures

Name	Time	Method
Change in - Short Form (SF) Question 3 (BPI-SF3)	Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment	The Brief Pain Inventory (BPI)has excellent psychometrics. The developers of the Brief Pain Inventory (BPI) recommend Brief Pain Inventory (BPI )3, the "pain worst" rating, as the primary response metric. The question asks participants to rate their worst pain in the prior 24-hours OR prior 7-day on a 0 to 10 Numerical Rating Scale (NRS), where "0" indicates "No pain" and "10" indicates "Pain as bad as you can imagine."

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life - Short Form - 12(QoL - SF 12)	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment	Quality of life - Short form - 12 (QoL - SF 12) is a health related Quality of life (QoL) measure that assesses physical functioning, role limitation because of physical health problems, bodily pain, social functioning, general mental health, role. Scoring: Two summary scores are a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100 with higher scores indicating better health.
Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The questions ask severity of pain based on an 0-10 numerical Rating Scale where 0 = no pain and 10 = the worst pain imaginable. In addition, it asks how much difficulty the participant has on a numerical rating scale where 0 = no difficulty and 10 = so difficult it requires help. Total disability score: _____/ 80 x 100 = %. Total SPADI score: _____ 130 x 100 = % Higher numbers indicate a higher level of disability (range 0-100%).
Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)	Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment	The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a laboratory based objective measure of ADL capacity. The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) is a timed test that provides a brief measure of functional ability of the upper limb while performing multi-level tasks that require grip/manipulation of the hand, elbow/shoulder reaching, sustained overhead work, and sustained positioning with an emphasis on assessing the limitations in functional capacity attributable to shoulder and neck disorders.The assessor measures the amount of time that the participant is able to perform each task using a stop watch. The task is completed 3 times- waist level, shoulder level, and eye level. Each task is continued for a maximum of 300 seconds or until a stopping criteria is reached. An overall summary score is calculated by averaging the time for the 3 tasks. Higher numbers indicate higher capacity (range 0-300 seconds).