ClinicalTrials.gg
Not yet recruitingNCT06207045Updated Jan 16, 2024

The Effects of Limb Elevation During Gout Flare Episodes

An interventional study of limb elevation in Gout Flare, sponsored by Thammasat University. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-16.

Sponsored by Thammasat University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

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.

02

Conditions studied

  • Gout Flare

Browse trials for

Keywords

  • Gout, arthritis, gout flare
03

In context

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

This study's planned enrollment of 30 is below the median of 83 across 286 interventional studies indexed under Gout.

Browse Gout studies →

Lead sponsor

Thammasat University is the lead sponsor of 85 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged ≥ 18 years
  • Diagnosis of Gout according to 2015 The ACR/EULAR gout classification criteria

Exclusion criteria

Exclusion Criteria:

  • Receive Non-Steroidal Anti-inflammatory Drugs or Intra-articular 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
  • \< 30 ml/min/1.73m2
  • Communication problems
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    limb elevation group

    limb elevation plus standard medication

    Procedure: limb elevation

  • No intervention
    control group

    standard medication only

Interventions

  • Procedurelimb elevation

    limb elevation more than 45 degrees

06

What researchers measure

Primary outcomes

  1. Reduction of pain score

    10-points Visual Analogue Scale

    Time frame: 48 hours

Secondary outcomes

  1. Joint circumference

    circumference of affected joint in centimeter

    Time frame: 48 hours

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2024; primary completion for May 2024, 3 months later.

Of 34 non-industry interventional studies with no phase under Gout, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's planned 3 months is below that.

Counting every sponsor, half of 35 studies reached it within 29 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 5, 2024
First posted
Jan 16, 2024
StartEst.
Feb 1, 2024
Primary completionEst.
May 31, 2024
CompletionEst.
Oct 31, 2024
Last update
Jan 16, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06207045
Lead sponsor
Thammasat University
Responsible party
saitip sangkamanovet (Dr., Thammasat University) — Principal investigator
First posted
Jan 16, 2024
Start date
Feb 1, 2024 (estimated)
Primary completion
May 31, 2024 (estimated)
Completion
Oct 31, 2024 (estimated)
Last update
Jan 16, 2024

Study contacts

RatchayaSaitip Lertnawapan
Contact
ratchas@yahoo.com
0973941619
kanon jatuworapruk
Contact
kanon@tu.ac.th
029269794
saitip sangkamanovet
principal investigator · Thammasat University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion