- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07814989
Wrist Nerve Block as a New Treatment in Patients With Rheumatoid Arthritis (RA: rheumatoid)
The Role of Wrist Nerve Block as a Therapeutic Modality in Patients With Rheumatoid Arthritis
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Youssra Ali Resident
- Phone Number: 00201122040682
- Email: youssralam3ie@gmail.com
Study Contact Backup
- Name: Ahmed mahrous elsamman
- Phone Number: 00201122040682
Study Locations
-
-
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Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- RA patients fulfilled the 2010 American College of Rheumatoid Arthritis classification criteria.[8]
- Oligoarticular RA patients including wrist joint.
- Age above 18 years old.
- Patient cooperative and can answer questions.
Exclusion Criteria:
- Other rheumatologic or collagen diseases.
- Age below 18 years.
- Patients who underwent concomitant procedures to address underlying pathology such as radial styloidectomy, ulna shortening, fracture fixation, arthroplasty, arthrodesis, and ligament reconstructions.
- Patients who suffered from hand deformities or limitation.
- Uncooperative patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 3
|
|
|
Active Comparator: Group 1
wrist nerve block
|
Wrist nerve block by injection is a diagnostic or therapeutic procedure used to treat chronic wrist pain, typically arising from arthritis or instability, by interrupting sensory nerve signals (mainly PIN/AIN nerves) with an anesthetic or neurolytic agent.
This less-invasive approach provides pain relief, often serving as a predictor for success before permanent surgical denervation.[4]
|
|
Placebo Comparator: Group 2
wrist local steroid injection
|
Wrist nerve block by injection is a diagnostic or therapeutic procedure used to treat chronic wrist pain, typically arising from arthritis or instability, by interrupting sensory nerve signals (mainly PIN/AIN nerves) with an anesthetic or neurolytic agent.
This less-invasive approach provides pain relief, often serving as a predictor for success before permanent surgical denervation.[4]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in wrist pain severity measured by the Visual Analogue Scale (VAS) from baseline to Week 16
Time Frame: Baseline to Week 16
|
Change in wrist pain severity measured using the Visual Analogue Scale (VAS) from baseline to Week 16 Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Wrist pain severity will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain. The change in VAS score from baseline to Week 16 will be assessed. |
Baseline to Week 16
|
|
Assessment of wrist pain improvement
Time Frame: 16 weeks
|
• Change in wrist pain severity measured by the Visual Analogue Scale (VAS) from baseline to Week 16
|
16 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-7-26MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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