CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 76 enrolled
Drug / intervention
Cold Water Immersionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04587544
NCT04587544N/ACompleted

Effect of a Cold Water Immersion (CWI) on Pain in People With Gouty Arthritis: A Community Based Randomized Controlled Trial

Taipei Medical University·interventional·Posted Oct 14, 2020·Updated Mar 17, 2021

In Brief

A clinical study evaluating Cold Water Immersion for Gout Arthritis. Completed, enrolled 76 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGout Arthritis
CountriesIndonesia
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 14, 2020
Enrollment StartJul 1, 2019
Primary CompletionJan 1, 2021
Study CompletionJan 31, 2021
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.7 years ago

Interventions

Cold Water Immersionbehavioral

The participants maintained their daily activities during the intervention. When daily activity ended, the intervention was begun. CWI therapy by immersed the whole part of inflamed target joints in the water at 20-30C for 20 minutes/day. The intervention was continued for four weeks. The researchers work together with the nurses of community health services to give the intervention.