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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Shoulder Pain

Intervention / Treatment
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* Drug: Lidocaine 1% Injectable Solution
* Drug: Triamcinolone Injection
* Procedure: Suprascapular Nerve Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group<br>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<br>* 2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch<br>Drug: Triamcinolone Injection<br>* 0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch<br>Procedure: Suprascapular Nerve Block<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overuse Shoulder Syndrome