Clinical trial NCT03752619: Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Official title: Peripheral Nerve Stimulation(PNS) for Subacromial Impingement Syndrome(SIS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Shoulder Impingement Syndrome
Shoulder Tendinitis
Shoulder Bursitis
Pain, Shoulder
Keywords: peripheral nerve stimulation
Sprint
stimulation
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
Collaborators: name: University of Texas
First posted: 2018-11-26
Enrollment: 116
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in - Short Form (SF) Question 3 (BPI-SF3)
timeFrame: Prior 7-days] ; Baseline (week 1), End of Treatment(week 9), 12 weeks post treatment, 24 weeks post treatment
Secondary outcomes:
measure: Change in Activities of Daily Living(ADL( Capacity - Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA)
timeFrame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
measure: Change in Activities of Daily Living (ADL) Performance -Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
measure: Change in Quality of Life - Short Form - 12(QoL - SF 12)
timeFrame: Baseline (week 1), End of Treatment(week 5), 12 weeks post treatment, 24 weeks post treatment
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Dallas
country: United States
facility: Univerity of Texas Southwestern
state: Texas
Study officials:
affiliation: MetroHealth Medical Center
name: Richard D Wilson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Urwin M, Symmons D, Allison T, Brammah T, Busby H, Roxby M, Simmons A, Williams G. Estimating the burden of musculoskeletal disorders in the community: the comparative prevalence of symptoms at different anatomical sites, and the relation to social deprivation. Ann Rheum Dis. 1998 Nov;57(11):649-55. doi: 10.1136/ard.57.11.649.
citation: Johnson MP, Crossley KL, O'neil ME, Al-Zakwani IS. Estimates of Direct Health Care Expenditures Among Individuals With Shoulder Dysfunction in the United States J Ortho Sports Phys Ther 2005;35(1,A4).
citation: Cadogan A, Laslett M, Hing WA, McNair PJ, Coates MH. A prospective study of shoulder pain in primary care: prevalence of imaged pathology and response to guided diagnostic blocks. BMC Musculoskelet Disord. 2011 May 28;12:119. doi: 10.1186/1471-2474-12-119.
citation: van der Windt DA, Koes BW, de Jong BA, Bouter LM. Shoulder disorders in general practice: incidence, patient characteristics, and management. Ann Rheum Dis. 1995 Dec;54(12):959-64. doi: 10.1136/ard.54.12.959.
citation: Arroll B, Goodyear-Smith F. Corticosteroid injections for painful shoulder: a meta-analysis. Br J Gen Pract. 2005 Mar;55(512):224-8.
citation: Crawshaw DP, Helliwell PS, Hensor EM, Hay EM, Aldous SJ, Conaghan PG. Exercise therapy after corticosteroid injection for moderate to severe shoulder pain: large pragmatic randomised trial. BMJ. 2010 Jun 28;340:c3037. doi: 10.1136/bmj.c3037.
citation: Cummins CA, Sasso LM, Nicholson D. Impingement syndrome: temporal outcomes of nonoperative treatment. J Shoulder Elbow Surg. 2009 Mar-Apr;18(2):172-7. doi: 10.1016/j.jse.2008.09.005. Epub 2008 Dec 18.
citation: Johansson K, Oberg B, Adolfsson L, Foldevi M. A combination of systematic review and clinicians' beliefs in interventions for subacromial pain. Br J Gen Pract. 2002 Feb;52(475):145-52.
citation: Litaker D, Pioro M, El Bilbeisi H, Brems J. Returning to the bedside: using the history and physical examination to identify rotator cuff tears. J Am Geriatr Soc. 2000 Dec;48(12):1633-7. doi: 10.1111/j.1532-5415.2000.tb03875.x.
citation: Morrison DS, Frogameni AD, Woodworth P. Non-operative treatment of subacromial impingement syndrome. J Bone Joint Surg Am. 1997 May;79(5):732-7. doi: 10.2106/00004623-199705000-00013.
citation: Cleland T, Jain NB, Chae J, Hansen KM, Hisel TZ, Gunzler DD, Whitehair VC, Kim CH, Wilson RD. The protocol for a multisite, double blind, randomized, placebo-controlled trial of axillary nerve stimulation for chronic shoulder pain. Trials. 2020 Mar 6;21(1):248. doi: 10.1186/s13063-020-4174-x.