A Phase 4 interventional study of Lidocaine 1% Injectable Solution and Triamcinolone Injection in Chronic Shoulder Pain, sponsored by University of Miami. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
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.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
Browse Shoulder Pain studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch
This procedure involves injection of a lidocaine and triamcinolone mixture into the suprascapular nerve in the suprascapular notch using ultrasound guidance for proper placement of drugs.
Number of participants at each Global Satisfaction Rating (GSR)
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Time frame: 1 month post procedure
Number of participants reporting treatment related adverse events
As per treating physician evaluation of participant adverse events related to the intervention
Time frame: Up to 12 months
Number of participants at each Global Satisfaction Rating
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Time frame: Up to 12 months post procedure
Change in NRS scores
Numerical rating scores (NRS) ranges from 0 to 10 with highest score indicating the maximum pain and the lowest score indicating the lowest amount of pain.
Time frame: Baseline, 12 months
Change in DASH Questionnaire scores
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire is a 30-item questionnaire evaluating the ability of the patient to perform upper extremity activities. The questions are measured on a 5-point Likert scale with 1 being no difficulty and 5 bring unable to perform the activity.
Time frame: Baseline, 12 months
Change in BPI-I scores
Brief Pain Inventory pain Interference items (BPI-I) scores ranges from 0-10 with the higher scores indicating greater pain.
Time frame: Baseline, 12 months
Plan to share: No
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This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Miami