Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
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|ClinicalTrials.gov Identifier: NCT05364099|
Recruitment Status : Not yet recruiting
First Posted : May 6, 2022
Last Update Posted : December 30, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Shoulder Pain||Drug: Lidocaine 1% Injectable Solution Drug: Triamcinolone Injection Procedure: Suprascapular Nerve Block||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries|
|Estimated Study Start Date :||January 1, 2024|
|Estimated Primary Completion Date :||July 1, 2025|
|Estimated Study Completion Date :||July 1, 2025|
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
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
Drug: 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.
- Number of participants at each Global Satisfaction Rating (GSR) [ Time Frame: 1 month post procedure ]Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
- Number of participants reporting treatment related adverse events [ Time Frame: Up to 12 months ]As per treating physician evaluation of participant adverse events related to the intervention
- Number of participants at each Global Satisfaction Rating [ Time Frame: Up to 12 months post procedure ]Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
- Change in NRS scores [ Time Frame: Baseline, 12 months ]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.
- Change in DASH Questionnaire scores [ Time Frame: Baseline, 12 months ]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.
- Change in BPI-I scores [ Time Frame: Baseline, 12 months ]Brief Pain Inventory pain Interference items (BPI-I) scores ranges from 0-10 with the higher scores indicating greater pain.
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05364099
|Contact: Lorenzo J Diaz, DO||305-585-9600||Lorenzo.firstname.lastname@example.org|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|Contact: Lorenzo J Diaz, DO 305-585-9600 Lorenzo.Diaz@jhsmiami.org|
|Principal Investigator: Timothy Tiu, MD|
|Principal Investigator:||Timothy Tiu, MD||University of Miami|
|Responsible Party:||Timothy Tiu, Assistant Professor, University of Miami|
|Other Study ID Numbers:||
|First Posted:||May 6, 2022 Key Record Dates|
|Last Update Posted:||December 30, 2022|
|Last Verified:||December 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
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Spinal Cord Injuries
Spinal Cord Diseases
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Membrane Transport Modulators
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