The Effects of Limb Elevation During Gout Flare Episodes

January 5, 2024 updated by: saitip sangkamanovet, Thammasat University

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: kanon jatuworapruk
  • Phone Number: 029269794
  • Email: kanon@tu.ac.th

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: limb elevation group
limb elevation plus standard medication
Procedure: limb elevation
limb elevation more than 45 degrees
No Intervention: control group
standard medication only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of pain score
Time Frame: 48 hours
10-points Visual Analogue Scale
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Joint circumference
Time Frame: 48 hours
circumference of affected joint in centimeter
48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: saitip sangkamanovet, Thammasat University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2024

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

October 31, 2024

Study Registration Dates

First Submitted

January 5, 2024

First Submitted That Met QC Criteria

January 5, 2024

First Posted (Estimated)

January 15, 2024

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-IM-4-290/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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