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

NCT05364099 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20220014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Shoulder Pain

Keywords

Overuse Shoulder Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Number of participants at each Global Satisfaction Rating

  Up to 12 months post procedure

• Change in NRS scores

  Baseline, 12 months

• Change in DASH Questionnaire scores

  Baseline, 12 months

• Change in BPI-I scores

  Baseline, 12 months

Study Arms (1)

Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group

EXPERIMENTAL

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; Drug: Triamcinolone Injection; Procedure: Suprascapular Nerve Block

Interventions

Lidocaine 1% Injectable Solution DRUG

2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch

Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group

Triamcinolone Injection DRUG

0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch

Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group

Suprascapular Nerve Block PROCEDURE

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.

Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. 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.
• \. Able and willing to comply with the protocol. 7. Able to give voluntary informed consent prior to the performance of any study-specific procedures.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Interventions

Lidocaine; Triamcinolone

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Timothy Tiu, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2022
• First Posted: May 6, 2022
• Study Start: November 27, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)