NCT04587544

The Relationship Between Cold Water Immersion and the Progression in Gout Arthritis

Completed NA Last updated 17 March 2021

What this trial tests

NA trial testing Cold Water Immersion in Gout Arthritis in 76 participants. Completed in 31 January 2021.

Timeline

1 July 2019

Primary endpoint
1 January 2021

31 January 2021

Quick facts

Lead sponsor	Taipei Medical University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	76
Start date	1 July 2019
Primary completion	1 January 2021
Estimated completion	31 January 2021
Sites	1 location across Indonesia

Drugs / interventions tested

• Cold Water Immersion

Conditions studied

• Gout Arthritis — all drugs for Gout Arthritis →

Sponsor

Taipei Medical University

Who can join

18 and older, any sex, with Gout Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Gouty arthritis is a type of autoinflammatory arthritis that generates higher levels of pain with only minimum movement in the joint. The pain is shown to have a negative correlation with the physical function, reduced peak ankle joint angular, mobility velocity , and physical function. As such, the investigator can conclude that gout arthritis led to raises intolerance foot pain, physical inactivity, and joint mobility reduction. Currently, intermittent drugs use for pain relief is suggested to contribute to the renal impairment side effect. However, the investigator found that there is a limited study that investigated non-pharmacological intervention among people with gouty arthritis. The pain among people with gouty arthritis has also been shown to increase the degree of depression, anxiety, and depression. Also, the high levels of pain, psychological distress, anxiety, and depression were found as the risk factor of poor Quality of Life (QOL). Cold therapy (cryotherapy) application has been proven as useful adjuvant therapy on pain among people with gouty arthritis. CWI therapy has twofold reduced the inflammation. Firstly, it attenuates metabolic processes in stressed tissues and slowing cytokine and myokine up-regulation that mediates inflammation. Second, CWI induces microvasculature vasoconstriction by perfusing stressed tissue and reducing the circulatory of tissue access to inflammatory cells. Meanwhile, the high prevalence of gouty arthritis has been presented in North Celebes, Indonesia. Moreover, more than 50% of patients are too late for effective therapy and they had observed tophi for 7 to 9 years before presenting for treatment. These empirical issues indicate that it is vital to investigate gouty arthritis-related risk factors to protect Indonesians from this disease. The investigator aims to investigate a unique analysis of the CWI (20-30C) therapy effect on pain, joint mobility, stress, anxiety, depression, QOL (encompasses PCS and MCS), physical activity (MET-h/week) in the multicenter-community setting with a longitudinal study design.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.