RECRUITING

SPR PNS for Chronic Shoulder Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Post-Market Observational Case Series Study of Percutaneous Peripheral Nerve Stimulation (PNS) for the Treatment of Chronic Shoulder Pain

Quick Facts

Study Start:2022-07-06
Study Completion:2024-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05649917

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 21 years old
  2. * Diagnosed with degenerative changes within the shoulder complex
  3. * Scheduled for a commercial SPRINT PNS procedure
  4. * Shoulder pain score at baseline \>5 as demonstrated by PROMIS 29
  5. * Able to understand and willing to take part in study and comply with all study requirements
  1. * No shoulder pain at rest
  2. * Pain exclusively in the anterior aspect of the shoulder
  3. * Confounding conditions such as cervical radiculopathy, inflammatory arthritis, complete rotator cuff tear, or ipsilateral shoulder surgery in the past one year
  4. * Daily opioid use \>90 m morphine equivalent at any point in the past month
  5. * Opioids for any condition other than shoulder pain
  6. * 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.
  7. * 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
  8. * Vulnerable populations (e.g., prisoners, minors, students, employees)
  9. * Workers Compensation
  10. * Pregnant

Contacts and Locations

Study Contact

Mehul J Desai, MD, MPH
CONTACT
202-808-8295
research@isppcenter.com
Selma Paul
CONTACT
202-808-8295
spaul@isppcenter.com

Principal Investigator

Mehul Desai, MD, MPH
PRINCIPAL_INVESTIGATOR
International Spine Pain & Performance Center

Study Locations (Sites)

International Spine Pain & Performance Center
Washington, District of Columbia, 20006
United States
International Spine Pain & Performance Center
Arlington, Virginia, 22205
United States

Collaborators and Investigators

Sponsor: International Spine, Pain and Performance Center

  • Mehul Desai, MD, MPH, PRINCIPAL_INVESTIGATOR, International Spine Pain & Performance Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-06
Study Completion Date2024-07

Study Record Updates

Study Start Date2022-07-06
Study Completion Date2024-07

Terms related to this study

Keywords Provided by Researchers

  • Peripheral Nerve Stimulation
  • Shoulder Pain
  • Shoulder Injuries

Additional Relevant MeSH Terms

  • Shoulder Pain
  • Shoulder Injuries
  • Shoulder Arthritis