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NCT05364099 | Withdrawn | Chronic Shoulder Pain

Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Sponsor:

University of Miami

Information provided by (Responsible Party):

Timothy Tiu

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.

Condition or disease

Chronic Shoulder Pain

Intervention/treatment

Lidocaine 1% Injectable Solution

Triamcinolone Injection

Suprascapular Nerve Block

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Actual Study Start Date : November 27, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024
Arm Intervention/treatment

Experimental: Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group

Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.

Drug: Lidocaine 1% Injectable Solution

Drug: Triamcinolone Injection

Procedure: Suprascapular Nerve Block
Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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 Criteria
  • 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
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries

Location Details

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Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, Florida

University of Miami

Miami, florida, United States, 33136