The Effects of Limb Elevation During Gout Flare Episodes

Gout Flare Clinical Trial

Official title:

The Effects of Limb Elevation During Gout Flare Episodes : A Pilot, Randomised Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06207045
• Other study ID #: MTU-EC-IM-4-290/66
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Thammasat University
• Contact: RatchayaSaitip Lertnawapan
• Phone: 0973941619
• Email: ratchas[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Gouty
• Gout
• Gout Flare

Intervention

Procedure:
• limb elevation
limb elevation more than 45 degrees

Locations

Country	Name	City	State
Thailand	Thammasat University	Pathum Thani

Sponsors (1)

Lead Sponsor	Collaborator
Thammasat University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain score	10-points Visual Analogue Scale	48 hours
Secondary	Joint circumference	circumference of affected joint in centimeter	48 hours