Gout FlareNCT06207045
The Effects of Limb Elevation During Gout Flare Episodes
A study testing limb elevation in people with Gout Flare, run by Thammasat University at 1 site in Thailand.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Flare
- What is being tested?
- limb elevation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Feb 2024to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years
- Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University
Pathum Thani, 12120
Saitip sangkamanovet, noonsaitip@gmail.com
Kanon Jatuworapruk, kanon@tu.ac.th
About this study
Official title: 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 ?
Read more
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
Read the 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
- Being tested
- limb elevation
- Keywords
- Gout, arthritis, gout flare
- Medical subject headings
- Gout, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
limb elevationProcedure or surgery
limb elevation more than 45 degrees
| Study group | Role | What they receive |
|---|---|---|
| limb elevation group | Experimental | limb elevation plus standard medication Receives: Procedure: limb elevation |
| control group | No intervention | standard medication only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pain score
10-points Visual Analogue Scale
Measured: 48 hours
Secondary outcomes (1)
Joint circumference
circumference of affected joint in centimeter
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion31 May 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout FlareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, saitip sangkamanovet, Thammasat University
- Investigators
- saitip sangkamanovet, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207045
- Sponsor's protocol ID
- MTU-EC-IM-4-290/66
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Limb Elevation During Gout Flare Episodes : A Pilot, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06207045
- Acronym / sponsor ID
- MTU-EC-IM-4-290/66
- Conditions
- Gout Flare
- Keywords
- Gout, arthritis, gout flare
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| limb elevation group | Experimental | Procedure: limb elevationlimb elevation plus standard medication |
| control group | No intervention | –standard medication only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 18 years
- Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| limb elevationlimb elevation more than 45 degrees | Procedure or surgery | limb elevation group |
Primary outcome
Reduction of pain score
Time frame: 48 hours
10-points Visual Analogue Scale
1 secondary outcome
Joint circumference
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
saitip sangkamanovet principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing limb elevation in people with Gout Flare, run by Thammasat University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RatchayaSaitip Lertnawapan (0973941619, ratchas@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pain score (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.