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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05364099
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Shoulder Pain	Drug: Lidocaine 1% Injectable Solution; Drug: Triamcinolone Injection; Procedure: Suprascapular Nerve Block	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
• Anticipated Study Start Date: Jan 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: Lidocaine 1% Injectable Solution; 2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch; Drug: 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.

Outcome Measures

Primary Outcome Measures

1. Number of participants at each Global Satisfaction Rating (GSR) [1 month post procedure]

   Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied

2. Number of participants reporting treatment related adverse events [Up to 12 months]

   As per treating physician evaluation of participant adverse events related to the intervention

Secondary Outcome Measures

1. Number of participants at each Global Satisfaction Rating [Up to 12 months post procedure]

   Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied

2. Change in NRS scores [Baseline, 12 months]

   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.

3. Change in DASH Questionnaire scores [Baseline, 12 months]

   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.

4. Change in BPI-I scores [Baseline, 12 months]

   Brief Pain Inventory pain Interference items (BPI-I) scores ranges from 0-10 with the higher scores indicating greater pain.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami

Investigators

• Principal Investigator: Timothy Tiu, MD, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Timothy Tiu, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT05364099
• Other Study ID Numbers: 20220014
• First Posted: May 6, 2022
• Last Update Posted: Aug 2, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Timothy Tiu, Assistant Professor, University of Miami: Overuse Shoulder Syndrome
• Additional relevant MeSH terms: Shoulder Pain; Spinal Cord Injuries; Triamcinolone; Lidocaine

Study Results

No Results Posted as of Aug 2, 2022