The Effects of Limb Elevation During Gout Flare Episodes
1 other identifier
interventional
30
1 country
1
Brief Summary
The goal of this open-label randomized controlled trial is to explore the benefit of limb elevation in inpatient gout flare episodes, compared with standard treatment The main questions are;
- Is limb elevation able to reduce pain during gout flare episodes to a greater degree compared with standard treatment ?
- Is Is limb elevation able to reduce joint swelling during gout flare episodes to a greater degree compared with standard treatment ? Participants will be divided into 2 group;
- Limb elevation group
- control group All participants will receive standard medical therapy consisting of colchicine 0.6 mg per day plus prednisolone 30 mg per day for 2 days
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2024
CompletedFirst Posted
Study publicly available on registry
January 16, 2024
CompletedStudy Start
First participant enrolled
February 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedJanuary 16, 2024
January 1, 2024
4 months
January 5, 2024
January 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of pain score
10-points Visual Analogue Scale
48 hours
Secondary Outcomes (1)
Joint circumference
48 hours
Study Arms (2)
limb elevation group
EXPERIMENTALlimb elevation plus standard medication
control group
NO INTERVENTIONstandard medication only
Interventions
Eligibility Criteria
You may qualify if:
- Aged ≥ 18 years
- Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria
You may not qualify if:
- Receive Non-Steroidal Anti-inflammatory Drugs or Intra-articular corticosteroids or prednisolone \> 10 mg within 24 hours before enrollment
- Unstable vital sign
- Receiving joint aspiration for release joint effusion ≥ 10 ml after enrollment
- Gout flares involve axial joints e.g. hip
- Glomerular Filtration Rates \< 30 ml/min/1.73m2
- Communication problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Thammasat University
Pathum Thani, 12120, Thailand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
saitip sangkamanovet
Thammasat University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
January 5, 2024
First Posted
January 16, 2024
Study Start
February 1, 2024
Primary Completion
May 31, 2024
Study Completion
October 31, 2024
Last Updated
January 16, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share