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

University of Miami

Status and phase: Withdrawn; Phase 4

Conditions: Chronic Shoulder Pain

Treatments: Drug: Lidocaine 1% Injectable Solution; Drug: Triamcinolone Injection; Procedure: Suprascapular Nerve Block

Study type: Interventional

Funder types: Other

Identifiers

NCT05364099

20220014

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

2. 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.

3. 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

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

Experimental group

Description:

Participants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone.

Treatment:

Procedure: Suprascapular Nerve Block

Drug: Triamcinolone Injection

Drug: Lidocaine 1% Injectable Solution