Recruiting

SPR PNS

Sponsor:

International Spine, Pain and Performance Center

Code:

NCT05649917

Conditions

Shoulder Pain

Shoulder Injuries

Shoulder Arthritis

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Shoulder Pain

Shoulder Injuries

Shoulder Arthritis

Study ID

NCT05649917

Start date

Jul 6, 2022

Status verified date

Sep, 2023

Completion date

Jul, 2024

Anticipated

Primary completion date

Jun, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Reduction in average pain and/or reduction in pain interference [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Mehul J Desai, MD, MPH

202-808-8295research@isppcenter.com

Selma Paul

202-808-8295spaul@isppcenter.com

Locations

International Spine Pain & Performance Center

Recruiting

Washington, District of Columbia, United States, 20006

Contacts

Mehul Desai, MD, MPH

202-808-8295research@isppcenter.com

Selma Paul, BS

202-808-8295spaul@isppcenter.com

Principal Investigator:

Mehul Desai, MD, MPH

International Spine Pain & Performance Center

Recruiting

Arlington, Virginia, United States, 22205

Contacts

Mehul Desai, MD, MPH

202-808-8295research@isppcenter.com

Selma Paul

202-808-8295spaul@isppcenter.com

Principal Investigator:

Mehul Desai, MD, MPH

More Information

Sponsor

International Spine, Pain and Performance Center

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Keywords

  • Peripheral Nerve Stimulation
  • Shoulder Pain
  • Shoulder Injuries

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by International Spine, Pain and Performance Center on 2023-09-28.