The Effects of Limb Elevation During Gout Flare Episodes : A Pilot, Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Thammasat University
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Reduction of pain score
Study Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged ≥ 18 years
- •Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Reduction of pain score
Time Frame: 48 hours
10-points Visual Analogue Scale
Secondary Outcomes
- Joint circumference(48 hours)
Investigators
saitip sangkamanovet
Dr.
Thammasat University