NCT05649917

Brief Summary

The purpose of this research is to gather post-market data regarding the effectiveness of the SPRINT Peripheral Nerve Stimulation (PNS) System for the treatment of chronic shoulder pain due to chronic degenerative changes of your shoulder. The System delivers mild electrical stimulation to the muscles in your shoulder. The System includes up to two leads (small wires) that are placed through your skin into your shoulder. The leads attach to a device worn on your body that deliver stimulation (called a Stimulator). The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 6, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2022

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

August 23, 2022

Last Update Submit

September 26, 2023

Conditions

Shoulder PainShoulder InjuriesShoulder Arthritis

Keywords

Peripheral Nerve StimulationShoulder PainShoulder Injuries

Outcome Measures

Primary Outcomes (1)

  • Reduction in average pain and/or reduction in pain interference

    Average pain intensity is measured using the PROMIS-29 v2.0 profile. The measure assesses pain intensity using a single 0-10 numeric rating scale. Average pain interference is measured using Brief Pain Inventory--Short Form Question #9 (BPI-9). BPI-9 uses a 0-10 numeric rating scale across seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance.)

    3 months

Secondary Outcomes (4)

  • Changes in pain intensity

    1 year

  • Changes in pain interference

    1 year

  • Changes in Shoulder Function

    1 year

  • Changes in shoulder range of motion

    1 year

Eligibility Criteria

Age21 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will enroll up to 20 patients with pain due to degenerative changes in the shoulder scheduled for commercial placement of the SPRINT PNS System.

You may qualify if:

  • At least 21 years old
  • Diagnosed with degenerative changes within the shoulder complex
  • Scheduled for a commercial SPRINT PNS procedure
  • Shoulder pain score at baseline \>5 as demonstrated by PROMIS 29
  • Able to understand and willing to take part in study and comply with all study requirements

You may not qualify if:

  • No shoulder pain at rest
  • Pain exclusively in the anterior aspect of the shoulder
  • Confounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one year
  • Daily opioid use \>90 m morphine equivalent at any point in the past month
  • Opioids for any condition other than shoulder pain
  • Deep brain stimulation (DBS) system, implanted active cardiac implant (e.g. pacemaker or defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap with the SPRINT system.
  • Any other condition that may interfere with the ability to participate in a clinical trial (e.g. anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled DM) as determined by the Investigator
  • Vulnerable populations (e.g., prisoners, minors, students, employees)
  • Workers Compensation
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Spine Pain & Performance Center

Washington D.C., District of Columbia, 20006, United States

RECRUITING

International Spine Pain & Performance Center

Arlington, Virginia, 22205, United States

RECRUITING

Related Publications (20)

  • Chillemi C, Franceschini V. Shoulder osteoarthritis. Arthritis. 2013;2013:370231. doi: 10.1155/2013/370231. Epub 2013 Jan 10.

    PMID: 23365745BACKGROUND

  • Buckwalter JA, Saltzman C, Brown T. The impact of osteoarthritis: implications for research. Clin Orthop Relat Res. 2004 Oct;(427 Suppl):S6-15. doi: 10.1097/01.blo.0000143938.30681.9d.

    PMID: 15480076BACKGROUND

  • Millett PJ, Gobezie R, Boykin RE. Shoulder osteoarthritis: diagnosis and management. Am Fam Physician. 2008 Sep 1;78(5):605-11.

    PMID: 18788237BACKGROUND

  • Chae J, Yu D, Walker M. Percutaneous, intramuscular neuromuscular electrical stimulation for the treatment of shoulder subluxation and pain in chronic hemiplegia: a case report. Am J Phys Med Rehabil. 2001 Apr;80(4):296-301. doi: 10.1097/00002060-200104000-00014.

    PMID: 11277137BACKGROUND

  • Yu DT, Chae J, Walker ME, Fang ZP. Percutaneous intramuscular neuromuscular electric stimulation for the treatment of shoulder subluxation and pain in patients with chronic hemiplegia: a pilot study. Arch Phys Med Rehabil. 2001 Jan;82(1):20-5. doi: 10.1053/apmr.2001.18666.

    PMID: 11239281BACKGROUND

  • Renzenbrink GJ, IJzerman MJ. Percutaneous neuromuscular electrical stimulation (P-NMES) for treating shoulder pain in chronic hemiplegia. Effects on shoulder pain and quality of life. Clin Rehabil. 2004 Jun;18(4):359-65. doi: 10.1191/0269215504cr759oa.

    PMID: 15180118BACKGROUND

  • Yu DT, Chae J, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Feldstein M, Fang ZP. Intramuscular neuromuscular electric stimulation for poststroke shoulder pain: a multicenter randomized clinical trial. Arch Phys Med Rehabil. 2004 May;85(5):695-704. doi: 10.1016/j.apmr.2003.07.015.

    PMID: 15129391BACKGROUND

  • Chae J, Yu DT, Walker ME, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Frost FS, Grill JH, Fang ZP. Intramuscular electrical stimulation for hemiplegic shoulder pain: a 12-month follow-up of a multiple-center, randomized clinical trial. Am J Phys Med Rehabil. 2005 Nov;84(11):832-42. doi: 10.1097/01.phm.0000184154.01880.72.

    PMID: 16244520BACKGROUND

  • Chae J, Ng A, Yu DT, Kirsteins A, Elovic EP, Flanagan SR, Harvey RL, Zorowitz RD, Fang ZP. Intramuscular electrical stimulation for shoulder pain in hemiplegia: does time from stroke onset predict treatment success? Neurorehabil Neural Repair. 2007 Nov-Dec;21(6):561-7. doi: 10.1177/1545968306298412. Epub 2007 Mar 16.

    PMID: 17369520BACKGROUND

  • Wilson RD, Bennett ME, Lechman TE, Stager KW, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Arch Phys Med Rehabil. 2011 May;92(5):837-40. doi: 10.1016/j.apmr.2010.11.003.

    PMID: 21530732BACKGROUND

  • Wilson RD, Harris MA, Bennett ME, Chae J. Single-lead percutaneous peripheral nerve stimulation for the treatment of shoulder pain from subacromial impingement syndrome. PM R. 2012 Aug;4(8):624-8. doi: 10.1016/j.pmrj.2012.03.002.

    PMID: 22920317BACKGROUND

  • Chae J, Wilson RD, Bennett ME, Lechman TE, Stager KW. Single-lead percutaneous peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case series. Pain Pract. 2013 Jan;13(1):59-67. doi: 10.1111/j.1533-2500.2012.00541.x. Epub 2012 Mar 26.

    PMID: 22448759BACKGROUND

  • Wilson RD, Gunzler DD, Bennett ME, Chae J. Peripheral nerve stimulation compared with usual care for pain relief of hemiplegic shoulder pain: a randomized controlled trial. Am J Phys Med Rehabil. 2014 Jan;93(1):17-28. doi: 10.1097/PHM.0000000000000011.

    PMID: 24355994BACKGROUND

  • Wilson RD, Harris MA, Gunzler DD, Bennett ME, Chae J. Percutaneous peripheral nerve stimulation for chronic pain in subacromial impingement syndrome: a case series. Neuromodulation. 2014 Dec;17(8):771-6; discussion 776. doi: 10.1111/ner.12152. Epub 2014 Feb 11.

    PMID: 24512114BACKGROUND

  • Wilson RD, Bennett ME, Nguyen VQC, Bock WC, O'Dell MW, Watanabe TK, Amundson RH, Hoyen HA, Chae J. Fully Implantable Peripheral Nerve Stimulation for Hemiplegic Shoulder Pain: A Multi-Site Case Series With Two-Year Follow-Up. Neuromodulation. 2018 Apr;21(3):290-295. doi: 10.1111/ner.12726. Epub 2017 Nov 22.

    PMID: 29164745BACKGROUND

  • Gilmore CA, Ilfeld BM, Rosenow JM, Li S, Desai MJ, Hunter CW, Rauck RL, Nader A, Mak J, Cohen SP, Crosby ND, Boggs JW. Percutaneous 60-day peripheral nerve stimulation implant provides sustained relief of chronic pain following amputation: 12-month follow-up of a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2019 Nov 17:rapm-2019-100937. doi: 10.1136/rapm-2019-100937. Online ahead of print.

    PMID: 31740443BACKGROUND

  • Gilmore CA, Kapural L, McGee MJ, Boggs JW. Percutaneous Peripheral Nerve Stimulation for Chronic Low Back Pain: Prospective Case Series With 1 Year of Sustained Relief Following Short-Term Implant. Pain Pract. 2020 Mar;20(3):310-320. doi: 10.1111/papr.12856. Epub 2019 Dec 2.

    PMID: 31693791BACKGROUND

  • Mainkar O, Solla CA, Chen G, Legler A, Gulati A. Pilot Study in Temporary Peripheral Nerve Stimulation in Oncologic Pain. Neuromodulation. 2020 Aug;23(6):819-826. doi: 10.1111/ner.13139. Epub 2020 Mar 17.

    PMID: 32185844BACKGROUND

  • Deer TR, Eldabe S, Falowski SM, Huntoon MA, Staats PS, Cassar IR, Crosby ND, Boggs JW. Peripherally Induced Reconditioning of the Central Nervous System: A Proposed Mechanistic Theory for Sustained Relief of Chronic Pain with Percutaneous Peripheral Nerve Stimulation. J Pain Res. 2021 Mar 12;14:721-736. doi: 10.2147/JPR.S297091. eCollection 2021.

    PMID: 33737830BACKGROUND

  • Dimitroulas T, Duarte RV, Behura A, Kitas GD, Raphael JH. Neuropathic pain in osteoarthritis: a review of pathophysiological mechanisms and implications for treatment. Semin Arthritis Rheum. 2014 Oct;44(2):145-54. doi: 10.1016/j.semarthrit.2014.05.011. Epub 2014 May 14.

    PMID: 24928208BACKGROUND

MeSH Terms

Conditions

Shoulder PainShoulder Injuries

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Mehul Desai, MD, MPH

    International Spine Pain & Performance Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehul J Desai, MD, MPH

CONTACT

202-808-8295research@isppcenter.com

Selma Paul

CONTACT

202-808-8295spaul@isppcenter.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Principal Investigator

Study Record Dates

First Submitted

August 23, 2022

First Posted

December 14, 2022

Study Start

July 6, 2022

Primary Completion

June 1, 2024

Study Completion

July 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Locations

US(2)