Chronic Shoulder PainPhase 4NCT05364099
Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
A Phase 4 study testing Lidocaine 1% Injectable Solution, Triamcinolone Injection and Suprascapular Nerve Block in people with Chronic Shoulder Pain, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Shoulder Pain
- What is being tested?
- Lidocaine 1% Injectable Solution, Triamcinolone Injection and Suprascapular Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Lidocaine 1% Injectable Solution, Triamcinolone Injection, Suprascapular Nerve Block
- Keywords
- Overuse Shoulder Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 1% Injectable SolutionDrug
2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch
Triamcinolone InjectionDrug
0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch
Suprascapular Nerve BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Lidocaine 1% Injectable Solution; Drug: Triamcinolone Injection; Procedure: Suprascapular Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants at each Global Satisfaction Rating (GSR)
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Measured: 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
Measured: Up to 12 months
Secondary outcomes (4)
Number of participants at each Global Satisfaction Rating
Global Satisfaction Score is rated as: Very Dissatisfied, Dissatisfied, Neutral, Satisfied and Very Satisfied
Measured: Up to 12 months post procedure
Change in NRS scores
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.
Measured: Baseline, 12 months
Change in DASH Questionnaire scores
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.
Measured: Baseline, 12 months
Change in BPI-I scores
Brief Pain Inventory pain Interference items (BPI-I) scores ranges from 0-10 with the higher scores indicating greater pain.
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start27 Nov 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Why it stopped: Unable to feasibly complete study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Shoulder PainStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Tiu, University of Miami
- Investigators
- Timothy Tiu, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364099
- Sponsor's protocol ID
- 20220014
- Status last verified
- Nov 2023
- First submitted
- 3 May 2022
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprascapular Nerve Block for Treatment of Shoulder Pain in Individuals With Spinal Cord Injuries
- ClinicalTrials.gov ID
- NCT05364099
- Acronym / sponsor ID
- 20220014
- Conditions
- Chronic Shoulder Pain
- Keywords
- Overuse Shoulder Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to feasibly complete study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group | Experimental | Drug: Lidocaine 1% Injectable Solution, Drug: Triamcinolone Injection, Procedure: Suprascapular Nerve BlockParticipants in this group will receive standard of care (SOC) suprascapular nerve block using a mixture of Lidocaine and Triamcinolone. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine 1% Injectable Solution2.5 ml of 1% Lidocaine will be administered via injection in suprascapular nerve in the suprascapular notch | Drug | Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group |
| Triamcinolone Injection0.5 ml 40mg/ml Triamcinolone will be administered via injection in suprascapular nerve in the suprascapular notch | Drug | Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group |
| Suprascapular Nerve BlockThis 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. | Procedure or surgery | Suprascapular Nerve Block in Participants with Spinal Cord Injuries (SCI) Group |
Primary outcome
Number of participants at each Global Satisfaction Rating (GSR)
Time frame: 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
Time frame: Up to 12 months
As per treating physician evaluation of participant adverse events related to the intervention
4 secondary outcomes
Number of participants at each Global Satisfaction Rating
Time frame: Up to 12 months post procedure
Change in NRS scores
Time frame: Baseline, 12 months
Change in DASH Questionnaire scores
Time frame: Baseline, 12 months
Change in BPI-I scores
Time frame: Baseline, 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Tiu, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 1% Injectable Solution, Triamcinolone Injection and Suprascapular Nerve Block in people with Chronic Shoulder Pain, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants at each Global Satisfaction Rating (GSR) (time frame: 1 month post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.