Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207045
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-16
First Post:
2024-01-05
Brief Title:
The Effects of Limb Elevation During Gout Flare Episodes
Sponsor:
Thammasat University
Organization:
Thammasat University
Study Overview
Official Title:
The Effects of Limb Elevation During Gout Flare Episodes A Pilot Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
1 Limb elevation group
2 control group All participants will receive standard medical therapy consisting of colchicine 06 mg per day plus prednisolone 30 mg per day for 2 days
Pain score and joint circumference will be recored at recruitment 24 hour and 48 hour
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
1 Limb elevation group
2 control group All participants will receive standard medical therapy consisting of colchicine 06 mg per day plus prednisolone 30 mg per day for 2 days
Pain score and joint circumference will be recored at recruitment 24 hour and 48 hour
Detailed Description:
Limb elevation has shown benefit in ankle sprain and venous insufficiency but its benefit has not been studied in people with gout flare In this open-label randomized controlled trial 30 adults diagnosed with gout flare during their hospitalization will be randomized to receive limb elevation plus standard medication for gout flare limb elevation group or standard medication only control group Primary outcome is reduction in 10-point visual analogue scale for pain at 48 hours after enrollment and the secondary outcome is the reduction of the circumference of affected joint at 48 hours after enrollment Comparison of pain score and joint circumference reduction will be made using Wilcoxon Rank-sum test Our study results may provide some evidence in support of limb elevation as a supplementary non-pharmacological therapy for relief of gout flare
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None