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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05364099
Other study ID # 20220014
Secondary ID
Status Withdrawn
Phase Phase 4
First received
Last updated
Start date November 27, 2023
Est. completion date January 1, 2024

Study information

Verified date November 2023
Source University of Miami
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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: 1. Contra-indications to the procedure (e.g. infection, coagulopathy) 2. History of active cancer within 5 years 3. Adhesive capsulitis 4. Prior history of regenerative medicine intervention 5. Glucocorticoid injection within the past four weeks 6. Any medical condition, including psychiatric illness, which would interfere with the interpretation of the study results or the conduct of the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Lidocaine 1% Injectable Solution
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
Triamcinolone Injection
0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch
Procedure:
Suprascapular Nerve Block
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.

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants at each Global Satisfaction Rating (GSR) Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied 1 month post procedure
Primary Number of participants reporting treatment related adverse events As per treating physician evaluation of participant adverse events related to the intervention Up to 12 months
Secondary Number of participants at each Global Satisfaction Rating Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied Up to 12 months post procedure
Secondary 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. Baseline, 12 months
Secondary 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. Baseline, 12 months
Secondary 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. Baseline, 12 months
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