Status:
WITHDRAWN
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Lead Sponsor:
University of Miami
Conditions:
Chronic Shoulder Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of using suprascapular nerve block for individuals with chronic spinal cord injury who have chronic shoulder pain.
Eligibility Criteria
Inclusion
- 1\. Male or female, 18-70 years of age, inclusive. 2 Neurological impairment secondary to SCI that occurred at least twelve (12) months prior to the Screening Visit; neurological level of injury between C6 and L5, inclusive.
- 3\. Non-ambulatory, except for exercise or therapy purposes. 4. Uses a manual wheelchair. 5 History of chronic shoulder pain for ≥6 months that has been unresponsive to conservative treatment (e.g. physical therapy, pharmacological agents), and is rated as ≥4 out of 10 on an 11-point Numeric Rating Scale (NRS) (0 = "no pain"; 10 = "most intense pain imaginable") for average shoulder pain intensity during the week leading up to the Screening Visit.
- 6\. Able and willing to comply with the protocol. 7. Able to give voluntary informed consent prior to the performance of any study-specific procedures.
Exclusion
- Contra-indications to the procedure (e.g. infection, coagulopathy)
- History of active cancer within 5 years
- Adhesive capsulitis
- Prior history of regenerative medicine intervention
- Glucocorticoid injection within the past four weeks
- Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study
Key Trial Info
Start Date :
November 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05364099
Start Date
November 27 2023
End Date
January 1 2024
Last Update
December 6 2023
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136