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

NCT ID: NCT05364099

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Shoulder Pain

Keywords

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Overuse Shoulder Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lidocaine 1% Injectable Solution

Intervention Type DRUG

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

Triamcinolone Injection

Intervention Type DRUG

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

Suprascapular Nerve Block

Intervention Type 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.

Interventions

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Lidocaine 1% Injectable Solution

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

Intervention Type DRUG

Triamcinolone Injection

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

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Timothy Tiu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Timothy Tiu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20220014

Identifier Type: -

Identifier Source: org_study_id