The Effects of Limb Elevation During Gout Flare Episodes

NCT ID: NCT06207045

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-10-31

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 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.

Conditions

Gout Flare

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

limb elevation group

limb elevation plus standard medication

Group Type: EXPERIMENTAL

limb elevation

Intervention Type: PROCEDURE

limb elevation more than 45 degrees

control group

standard medication only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

limb elevation

limb elevation more than 45 degrees

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thammasat University

OTHER

Sponsor Role: lead

Responsible Party

saitip sangkamanovet

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

saitip sangkamanovet

Role: PRINCIPAL_INVESTIGATOR

Thammasat University

Locations

Thammasat University

Pathum Thani, , Thailand

Countries

Thailand

Central Contacts

RatchayaSaitip Lertnawapan

Role: CONTACT

ratchas@yahoo.com

0973941619

kanon jatuworapruk

Role: CONTACT

kanon@tu.ac.th

029269794

Facility Contacts

Saitip sangkamanovet

Role: primary

noonsaitip@gmail.com

Kanon Jatuworapruk

Role: backup

kanon@tu.ac.th

Other Identifiers

MTU-EC-IM-4-290/66

Identifier Type: -

Identifier Source: org_study_id