Chronic Shoulder Pain
Conditions
Keywords
Overuse Shoulder Syndrome
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.
Interventions
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch
PROCEDURESuprascapular 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.
Sponsors
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed