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

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05364099
• Other study ID #: 20220014
• Status: Withdrawn
• Phase: Phase 4
• 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
• 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• Status: Withdrawn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

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain
• Spinal Cord Injuries

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