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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05364099
Recruitment Status : Not yet recruiting
First Posted : May 6, 2022
Last Update Posted : December 30, 2022
Sponsor:
Information provided by (Responsible Party):
Timothy Tiu, University of Miami

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 Intervention/treatment Phase
Chronic Shoulder Pain Drug: Lidocaine 1% Injectable Solution Drug: Triamcinolone Injection Procedure: Suprascapular Nerve Block Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


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
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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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
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:

  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

Information from the National Library of Medicine

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


Contacts
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Contact: Lorenzo J Diaz, DO 305-585-9600 Lorenzo.diaz@jhsmiami.org

Locations
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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         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Timothy Tiu, MD University of Miami
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Responsible Party: Timothy Tiu, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05364099    
Other Study ID Numbers: 20220014
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

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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
Keywords provided by Timothy Tiu, University of Miami:
Overuse Shoulder Syndrome
Additional relevant MeSH terms:
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Shoulder Pain
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Triamcinolone
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists