Back to resultsSuprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Primary Purpose
Chronic Shoulder Pain
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine 1% Injectable Solution
Triamcinolone Injection
Suprascapular Nerve Block
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Shoulder Pain focused on measuring Overuse Shoulder Syndrome
Eligibility 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:
- 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
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Arm Description
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Outcomes
Primary Outcome Measures
Number of participants at each Global Satisfaction Rating (GSR)
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Number of participants reporting treatment related adverse events
As per treating physician evaluation of participant adverse events related to the intervention
Secondary Outcome Measures
Number of participants at each Global Satisfaction Rating
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05364099
Brief Title
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Official Title
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain
Keywords
Overuse Shoulder Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group
Arm Type
Experimental
Arm Description
Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.
Intervention Type
Drug
Intervention Name(s)
Lidocaine 1% Injectable Solution
Intervention Description
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Injection
Intervention Description
0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch
Intervention Type
Procedure
Intervention Name(s)
Suprascapular Nerve Block
Intervention Description
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 Measure Information:
Title
Number of participants at each Global Satisfaction Rating (GSR)
Description
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Time Frame
1 month post procedure
Title
Number of participants reporting treatment related adverse events
Description
As per treating physician evaluation of participant adverse events related to the intervention
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Number of participants at each Global Satisfaction Rating
Description
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Time Frame
Up to 12 months post procedure
Title
Change in NRS scores
Description
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
Title
Change in DASH Questionnaire scores
Description
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
Title
Change in BPI-I scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lorenzo J Diaz, DO
Phone
305-585-9600
Email
Lorenzo.diaz@jhsmiami.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Tiu, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lorenzo J Diaz, DO
Phone
305-585-9600
Email
Lorenzo.Diaz@jhsmiami.org
First Name & Middle Initial & Last Name & Degree
Timothy Tiu, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
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