Gout ArthritisNCT04587544
The Relationship Between Cold Water Immersion and the Progression in Gout Arthritis
A study testing Cold Water Immersion in people with Gout Arthritis, run by Taipei Medical University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gout Arthritis
- What is being tested?
- Cold Water Immersion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2019to 31 Jan 2021
- 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
- People with gouty arthritis in the knee or ankle or metatarsophalangeal or metacarpophalangeal or olecranon bursa or wrist
- Participants were Indonesian nationals aged ≥18 years
- They had visited a clinic of the Public CHS of Tomohon City
- They had agreed to participate in the study.
Who cannot join
- Participants who self-reported the presence of other types of inflammatory arthritis, including RA or spondyloarthritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Cold Water Immersion (CWI) on Pain in People With Gouty Arthritis: A Community Based Randomized Controlled Trial
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.
Read the detailed description
This research was conducted at North Celebes, Indonesia. Participants were recruited using the multi-stage sampling method, which began in July 2019. North Celebes Province was conveniently selected in the first stage sampling, which had the highest prevalence of gouty arthritis. North Celebes province is stratified it into 15 regions. In the second stage, two regions of fifteen regions were randomly selected, including urban and rural areas. Tomohon City is the one urban area that has been able to engage in this partnership. Seven Community Health Service (CHS) centers in Tomohon City have been randomly chosen in the final level. Four qualified professional nurses collected all the data. The data source of diagnoses was their medical records in the Public Community Health Services (CHS) of Tomohon City. The sample calculation utilized G-Power 3.1 software with the alpha level (α) of 0.01, power (1-ß) of 0.80, and the effect size is 0.9, the total estimated sample size required 31 in each group. An estimated 20% dropout rate increases; the sample size is 36 for each group.
Variable description 1.1.1. Participants Characteristic Blood pressure and BMI were examined in a standardized medical examination. Demographic data were collected by using a self-designed questionnaire. The questionnaire included the demographic characteristics of the participant, including age, gender, marital status, educational level, income, occupation, family gout history, gouty arthritis drug consumption, alcohol consumption, and smoking status. The translated food frequency questionnaire was employed with Cronbach's alpha as 0.95.
1.1.2. Pain The Visual Analog Scale (VAS) instrument has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm. The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89.
1.1.3. Joint mobility The range of knee joint motion was calculated using an International Standard Orthopedic Measurement (ISOM) goniometric. Its method using the Sagittal Frontal Transverse Rotation (SFTR) system to an accuracy of 10. Goniometry provides an objective assessment tool to measure the range of motion. The validity and reliability of Goniometry are 0.98 and 0.97, respectively. The validity score of the Indonesian version is 0.97, and the Cronbach alpha as 0.51.
1.1.4. Stress, anxiety, depression The Depression Anxiety Stress Scale (DASS-21) questionnaire is used to measure the negative states of three mental health conditions: depression, anxiety, and stress using a self-report 4-point Likert scale. Data was collected by reflects the thoughts, feelings, and behavior. The result will be defined by the total scores of responses from the 7-item subscale of this questionnaire. The Cronbach's alphas of Indonesian translated is 0.72 to 0.87.
1.1.5. Quality of Life (QOL) 36 Health Survey (SF-36) questionnaire was employed to estimate QOL. It included Physical Component Summary (PCS), Mental Component Summary (MCS). Total QOL range from 0 to 100. The Indonesia version of the SF-36 questionnaire has tested the reliability with the Cronbach's alphas 0.7.
1.1.6. Physical activity (MET-h/week) The physical activity level was investigated as metabolic equivalent of task (MET)-hr/week by using three questions based on the modified Physical Activity Guideline from the Advisory Committee for Americans and the Godin Leisure-Time Exercise Questionnaire. The investigator then categorized participants based on the exercise type (that is divided into the following categories: mild (e.g., yoga, bowling, or floor-sweeping), moderate (e.g., gym, baseball, or badminton), and strenuous exercise (e.g., hiking, soccer, or running)), duration in minutes and exercise intensity they presented during a typical week. The investigator multiplied the amount of mild, moderate, and strenuous exercise hours and duration by 3, 5, and 9, respectively. By summing the exercise pattern of the separate things, the investigator measured total weekly PA in arbitrary units.
The per-protocol method was employed to deal with the missing data. Each participant is allowed to immediately report the adverse event during the intervention.
The Chi-square and t-test were employed to analyze the homogeneity of subject characteristics between the experimental and control group. The Generalized Estimating Equation (GEE) model was applied to compare the differences pain, joint mobility, stress, anxiety, depression, QOL (included PCS and MCS), physical activity (MET-h/week) within one-month intervention between the intervention and control group. The interaction between group and time was also further analyzed to determine if the mean differences in their pain, joint mobility, stress anxiety, and depression, QOL, and physical activity between groups differed significantly over time. p<0.05 was applied as statistically significant. All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) vers. 25.0 (Chicago, IL, USA). Besides, Structural Equation Modeling (SEM) was also employed to analyze the mediating effect between variables through the Analysis of Moment Structures (AMOS) vers. 24. Then the investigator evaluate the measurement and structural models by utilizing the goodness fit index.
- Conditions
- Gout Arthritis
- Being tested
- Cold Water Immersion
- Keywords
- Gout Arthritis, Cold Water Immersion, Pain
- Medical subject headings
- Arthritis, Gouty, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold Water ImmersionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cold Water Immersion | Experimental | 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. Receives: Behavioral: Cold Water Immersion |
| No Intervention | No intervention | The participants would not receive Cold Water Intervention. However, they are allowed to received the usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Level assessed by The Visual Analog Scale (VAS) at the baseline
Pain Level assessed by the Visual Analog Scale (VAS) instrument that has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
Measured: Baseline/ pre-intervention
Pain Level assessed by The Visual Analog Scale (VAS) at the 2nd week/during the intervention
Pain Level assessed by The Visual Analog Scale (VAS) instrument that has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
Measured: 2nd week/during the intervention
Pain Level assessed by the Visual Analog Scale (VAS) at 4th week/immediately after intervention
Pain Level assessed by the Visual Analog Scale (VAS) instrument has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
Measured: 4th week/immediately after intervention
Secondary outcomes (12)
Joint mobility assessed by Goniometry at the baseline
Joint mobility assessed by Goniometry. The range of knee joint motion was calculated using an International Standard Orthopedic Measurement (ISOM) goniometric. Its method using the Sagittal Frontal Transverse Rotation (SFTR) system to an accuracy of 10 (Dorwart, Hansell, \& Schumacher, 1974). Goniometry provides an objective assessment tool to measure the range of motion (Rose \& Norton, 1987). The validity and reliability of Goniometry are 0.98 and 0.97, respectively (Rose \& Norton, 1987). The validity score of the Indonesian version is 0.97, and the Cronbach alpha as 0.51 (Hafiyah, 2013).
Measured: Baseline/ pre-intervention
Joint mobility assessed by Goniometry at the 2nd week/during the intervention
Joint mobility assessed by Goniometry. The range of knee joint motion was calculated using an International Standard Orthopedic Measurement (ISOM) goniometric. Its method using the Sagittal Frontal Transverse Rotation (SFTR) system to an accuracy of 10 (Dorwart, Hansell, \& Schumacher, 1974). Goniometry provides an objective assessment tool to measure the range of motion (Rose \& Norton, 1987). The validity and reliability of Goniometry are 0.98 and 0.97, respectively (Rose \& Norton, 1987). The validity score of the Indonesian version is 0.97, and the Cronbach alpha as 0.51 (Hafiyah, 2013).
Measured: 2nd week/during the intervention
Joint mobility assessed by Goniometry at the 4th week/immediately after intervention
Joint mobility assessed by Goniometry. The range of knee joint motion was calculated using an International Standard Orthopedic Measurement (ISOM) goniometric. Its method using the Sagittal Frontal Transverse Rotation (SFTR) system to an accuracy of 10 (Dorwart, Hansell, \& Schumacher, 1974). Goniometry provides an objective assessment tool to measure the range of motion (Rose \& Norton, 1987). The validity and reliability of Goniometry are 0.98 and 0.97, respectively (Rose \& Norton, 1987). The validity score of the Indonesian version is 0.97, and the Cronbach alpha as 0.51 (Hafiyah, 2013).
Measured: 4th week/immediately after intervention
Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the baseline
The Depression Anxiety Stress Scale questionnaire is used to measure the negative states of three mental health conditions: depression, anxiety, and stress using a self-report 4-point Likert scale. Data was collected by reflects the thoughts, feelings, and behavior (Oei, Sawang, Goh, \& Mukhtar, 2013). The result will be defined by the total scores of responses from the 7-item subscale of this questionnaire. The lower score shows a better result. If the total number of depressions is 9 or below and the extremely severe is 34 or over. The Cronbach's alphas of Indonesian translated is 0.72 to 0.87 (Susilowati, Isahak, \& Harncharoen, 2016).
Measured: Baseline/ pre-intervention
Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the 2nd week/during the intervention
The Depression Anxiety Stress Scale questionnaire is used to measure the negative states of three mental health conditions: depression, anxiety, and stress using a self-report 4-point Likert scale. Data was collected by reflects the thoughts, feelings, and behavior (Oei, Sawang, Goh, \& Mukhtar, 2013). The result will be defined by the total scores of responses from the 7-item subscale of this questionnaire. The lower score shows a better result. If the total number of depressions is 9 or below and the extremely severe is 34 or over. The Cronbach's alphas of Indonesian translated is 0.72 to 0.87 (Susilowati, Isahak, \& Harncharoen, 2016).
Measured: 2nd week/during the intervention
Stress, anxiety, depression assessed by the Depression Anxiety Stress Scale at 4th week/immediately after intervention
The Depression Anxiety Stress Scale questionnaire is used to measure the negative states of three mental health conditions: depression, anxiety, and stress using a self-report 4-point Likert scale. Data was collected by reflects the thoughts, feelings, and behavior (Oei, Sawang, Goh, \& Mukhtar, 2013). The result will be defined by the total scores of responses from the 7-item subscale of this questionnaire. The lower score shows a better result. If the total number of depressions is 9 or below and the extremely severe is 34 or over. The Cronbach's alphas of Indonesian translated is 0.72 to 0.87 (Susilowati, Isahak, \& Harncharoen, 2016).
Measured: 4th week/immediately after intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire at Baseline
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire that was employed to estimate QOL. It included Physical Component Summary (PCS), Mental Component Summary (MCS). Total QOL range from 0 to 100 (Rias et al., 2020). The Indonesia version of the SF-36 questionnaire has tested the reliability with the Cronbach's alphas 0.7 (Salim, Yamin, Alwi, \& Setiati, 2015)
Measured: Baseline, pre-intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire 2nd week/during the intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire that was employed to estimate QOL. It included Physical Component Summary (PCS), Mental Component Summary (MCS). Total QOL range from 0 to 100 (Rias et al., 2020). The Indonesia version of the SF-36 questionnaire has tested the reliability with the Cronbach's alphas 0.7 (Salim, Yamin, Alwi, \& Setiati, 2015)
Measured: 2nd week/during the intervention
Quality of Life (QOL) level assessed by36 Health Survey (SF-36) questionnaire 4th week/immediately after intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire that was employed to estimate QOL. It included Physical Component Summary (PCS), Mental Component Summary (MCS). Total QOL range from 0 to 100 (Rias et al., 2020). The Indonesia version of the SF-36 questionnaire has tested the reliability with the Cronbach's alphas 0.7 (Salim, Yamin, Alwi, \& Setiati, 2015)
Measured: 4th week/immediately after intervention
Physical activity (MET-h/week) level assessed by questions based on the modified Physical Activity Guideline at the baseline
The physical activity level was investigated as metabolic equivalent of task (MET)-hr/week by using three questions based on the modified Physical Activity Guideline from the Advisory Committee for Americans (Shiroma, Sesso, Moorthy, Buring, \& Lee, 2015) and the Godin Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1997). We then categorized participants based on the exercise type (that is divided into the following categories: mild (e.g., yoga, bowling, or floor-sweeping), moderate (e.g., gym, baseball, or badminton), and strenuous exercise (e.g., hiking, soccer, or running)), duration in minutes and exercise intensity they presented during a typical week. We multiplied the amount of mild, moderate, and strenuous exercise hours and duration by 3, 5, and 9, respectively. By summing the exercise pattern of the separate things, we measured total weekly PA in arbitrary units (Rias et al., 2020).
Measured: Baseline, pre-intervention
Physical activity (MET-h/week) level assessed by questions based on the modified Physical Activity Guideline at 2nd week/during the intervention
The physical activity level was investigated as metabolic equivalent of task (MET)-hr/week by using three questions based on the modified Physical Activity Guideline from the Advisory Committee for Americans (Shiroma, Sesso, Moorthy, Buring, \& Lee, 2015) and the Godin Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1997). We then categorized participants based on the exercise type (that is divided into the following categories: mild (e.g., yoga, bowling, or floor-sweeping), moderate (e.g., gym, baseball, or badminton), and strenuous exercise (e.g., hiking, soccer, or running)), duration in minutes and exercise intensity they presented during a typical week. We multiplied the amount of mild, moderate, and strenuous exercise hours and duration by 3, 5, and 9, respectively. By summing the exercise pattern of the separate things, we measured total weekly PA in arbitrary units (Rias et al., 2020).
Measured: 2nd week/during the intervention
Physical activity (MET-h/week) level: Change from Baseline and 2nd week time point
The physical activity level was investigated as metabolic equivalent of task (MET)-hr/week by using three questions based on the modified Physical Activity Guideline from the Advisory Committee for Americans (Shiroma, Sesso, Moorthy, Buring, \& Lee, 2015) and the Godin Leisure-Time Exercise Questionnaire (Godin \& Shephard, 1997). We then categorized participants based on the exercise type (that is divided into the following categories: mild (e.g., yoga, bowling, or floor-sweeping), moderate (e.g., gym, baseball, or badminton), and strenuous exercise (e.g., hiking, soccer, or running)), duration in minutes and exercise intensity they presented during a typical week. We multiplied the amount of mild, moderate, and strenuous exercise hours and duration by 3, 5, and 9, respectively. By summing the exercise pattern of the separate things, we measured total weekly PA in arbitrary units (Rias et al., 2020).
Measured: 4th week/immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Jul 2019
- Primary completion1 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (45)Papers the sponsor has linked to this study.
- Other trials for Gout ArthritisStudies 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
- Model description
- The randomized control trial study with two parallel-intervention-groups was employed to examine the effect of CWI (20-30C) therapy. All participants were randomly assigned to either CWI (20-30C) therapy intervention group or the control group. Block random sampling was then employed to generate the intervention and control group sequence. All participants were assessed on their pain as the primary outcome, joint mobility, stress, anxiety, depression, QOL (included PCS and MCS), physical activity (MET-h/week) at three times points: before the intervention, 2nd and 4th-week of the intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Dyah Kurniasari, Taipei Medical University
- Investigators
- Hsiu Ting Tsai, PhD, Study director, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587544
- Sponsor's protocol ID
- N201912052
- Status last verified
- Mar 2021
- First submitted
- 24 Sep 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abhishek A, Doherty M. Education and non-pharmacological approaches for gout. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i51-i58. doi: 10.1093/rheumatology/kex421.
PubMed 29272507Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.
PubMed 22336838Burke BT, Kottgen A, Law A, Windham BG, Segev D, Baer AN, Coresh J, McAdams-DeMarco MA. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1730-8. doi: 10.1002/acr.22648.
PubMed 26138016Albar, Z. (2007). Gout: Diagnosis and management. Medical Journal of Indonesia, 16(1), 47-54. https://doi.org/10.13181/mji.v16i1.256
Amanah, A., Komala, I., Kurniasari, M. D., Dharmana, E., & Gasem, M. H. (2018). Effect of Mangosteen ( Garcinia mangostana ) PEEL Extract towards CD4 + , CD8 + T LYMPHOCYTES , CD38 Expression , NK Cells , IL-2 and IFN γ in Hiv Patients with Antiretroviral Therapy. Hiroshima Journal of Medical Sciences, 67(24), 56-62.
Carroll M, Boocock M, Dalbeth N, Stewart S, Frampton C, Rome K. Ankle joint function during walking in tophaceous gout: A biomechanical gait analysis study. Gait Posture. 2018 Jun;63:150-153. doi: 10.1016/j.gaitpost.2018.04.020. Epub 2018 Apr 17.
PubMed 29734124Chandratre P, Mallen CD, Roddy E, Liddle J, Richardson J. "You want to get on with the rest of your life": a qualitative study of health-related quality of life in gout. Clin Rheumatol. 2016 May;35(5):1197-205. doi: 10.1007/s10067-015-3039-2. Epub 2015 Aug 6.
PubMed 26245722Chandratre P, Mallen C, Richardson J, Muller S, Hider S, Rome K, Blagojevic-Bucknall M, Roddy E. Health-related quality of life in gout in primary care: Baseline findings from a cohort study. Semin Arthritis Rheum. 2018 Aug;48(1):61-69. doi: 10.1016/j.semarthrit.2017.12.005. Epub 2018 Jan 5.
PubMed 29398125DiBonaventura Md, Andrews LM, Yadao AM, Kahler KH. The effect of gout on health-related quality of life, work productivity, resource use and clinical outcomes among patients with hypertension. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):821-9. doi: 10.1586/erp.12.60.
PubMed 23252362Dorwart BB, Hansell JR, Schumacher HR Jr. Effects of cold and heat on urate crystal-induced synovitis in the dog. Arthritis Rheum. 1974 Sep-Oct;17(5):563-71. doi: 10.1002/art.1780170510. No abstract available.
PubMed 4413123Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.
PubMed 2213777Fields TR. The Challenges of Approaching and Managing Gout. Rheum Dis Clin North Am. 2019 Feb;45(1):145-157. doi: 10.1016/j.rdc.2018.09.009.
PubMed 30447743Fu T, Cao H, Yin R, Zhang L, Zhang Q, Li L, Gu Z. Associated factors with functional disability and health-related quality of life in Chinese patients with gout: a case-control study. BMC Musculoskelet Disord. 2017 Nov 3;18(1):429. doi: 10.1186/s12891-017-1787-7.
PubMed 29100504Godin, G., & Shephard, R. J. . (1997). Godin leisure-time exercise questionnaire. Medicine and Science in Sports and Exercise, 29(6), 36-38.
Hafiyah, F. (2013). Kontribusi Fleksibilitas Pergelangan Tangan dan Fleksibilitas Pinggang Terhadap Hasil Standing Shoot Dalam Perainan Bola Tangan Jurnal. Bandung.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Cold Water Immersion (CWI) on Pain in People With Gouty Arthritis: A Community Based Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04587544
- Acronym / sponsor ID
- N201912052
- Conditions
- Gout Arthritis
- Keywords
- Gout Arthritis, Cold Water Immersion, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 14 Oct 2020 (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.
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.
Detailed description
This research was conducted at North Celebes, Indonesia. Participants were recruited using the multi-stage sampling method, which began in July 2019. North Celebes Province was conveniently selected in the first stage sampling, which had the highest prevalence of gouty arthritis. North Celebes province is stratified it into 15 regions. In the second stage, two regions of fifteen regions were randomly selected, including urban and rural areas. Tomohon City is the one urban area that has been able to engage in this partnership. Seven Community Health Service (CHS) centers in Tomohon City have been randomly chosen in the final level. Four qualified professional nurses collected all the data. The data source of diagnoses was their medical records in the Public Community Health Services (CHS) of Tomohon City. The sample calculation utilized G-Power 3.1 software with the alpha level (α) of 0.01, power (1-ß) of 0.80, and the effect size is 0.9, the total estimated sample size required 31 in each group. An estimated 20% dropout rate increases; the sample size is 36 for each group.
Variable description 1.1.1. Participants Characteristic Blood pressure and BMI were examined in a standardized medical examination. Demographic data were collected by using a self-designed questionnaire. The questionnaire included the demographic characteristics of the participant, including age, gender, marital status, educational level, income, occupation, family gout history, gouty arthritis drug consumption, alcohol consumption, and smoking status. The translated food frequency questionnaire was employed with Cronbach's alpha as 0.95.
1.1.2. Pain The Visual Analog Scale (VAS) instrument has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm. The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89.
1.1.3. Joint mobility The range of knee joint motion was calculated using an International Standard Orthopedic Measurement (ISOM) goniometric. Its method using the Sagittal Frontal Transverse Rotation (SFTR) system to an accuracy of 10. Goniometry provides an objective assessment tool to measure the range of motion. The validity and reliability of Goniometry are 0.98 and 0.97, respectively. The validity score of the Indonesian version is 0.97, and the Cronbach alpha as 0.51.
1.1.4. Stress, anxiety, depression The Depression Anxiety Stress Scale (DASS-21) questionnaire is used to measure the negative states of three mental health conditions: depression, anxiety, and stress using a self-report 4-point Likert scale. Data was collected by reflects the thoughts, feelings, and behavior. The result will be defined by the total scores of responses from the 7-item subscale of this questionnaire. The Cronbach's alphas of Indonesian translated is 0.72 to 0.87.
1.1.5. Quality of Life (QOL) 36 Health Survey (SF-36) questionnaire was employed to estimate QOL. It included Physical Component Summary (PCS), Mental Component Summary (MCS). Total QOL range from 0 to 100. The Indonesia version of the SF-36 questionnaire has tested the reliability with the Cronbach's alphas 0.7.
1.1.6. Physical activity (MET-h/week) The physical activity level was investigated as metabolic equivalent of task (MET)-hr/week by using three questions based on the modified Physical Activity Guideline from the Advisory Committee for Americans and the Godin Leisure-Time Exercise Questionnaire. The investigator then categorized participants based on the exercise type (that is divided into the following categories: mild (e.g., yoga, bowling, or floor-sweeping), moderate (e.g., gym, baseball, or badminton), and strenuous exercise (e.g., hiking, soccer, or running)), duration in minutes and exercise intensity they presented during a typical week. The investigator multiplied the amount of mild, moderate, and strenuous exercise hours and duration by 3, 5, and 9, respectively. By summing the exercise pattern of the separate things, the investigator measured total weekly PA in arbitrary units.
The per-protocol method was employed to deal with the missing data. Each participant is allowed to immediately report the adverse event during the intervention.
The Chi-square and t-test were employed to analyze the homogeneity of subject characteristics between the experimental and control group. The Generalized Estimating Equation (GEE) model was applied to compare the differences pain, joint mobility, stress, anxiety, depression, QOL (included PCS and MCS), physical activity (MET-h/week) within one-month intervention between the intervention and control group. The interaction between group and time was also further analyzed to determine if the mean differences in their pain, joint mobility, stress anxiety, and depression, QOL, and physical activity between groups differed significantly over time. p<0.05 was applied as statistically significant. All statistical analyses were performed using the Statistical Package for the Social Sciences (SPSS) vers. 25.0 (Chicago, IL, USA). Besides, Structural Equation Modeling (SEM) was also employed to analyze the mediating effect between variables through the Analysis of Moment Structures (AMOS) vers. 24. Then the investigator evaluate the measurement and structural models by utilizing the goodness fit index.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The randomized control trial study with two parallel-intervention-groups was employed to examine the effect of CWI (20-30C) therapy. All participants were randomly assigned to either CWI (20-30C) therapy intervention group or the control group. Block random sampling was then employed to generate the intervention and control group sequence. All participants were assessed on their pain as the primary outcome, joint mobility, stress, anxiety, depression, QOL (included PCS and MCS), physical activity (MET-h/week) at three times points: before the intervention, 2nd and 4th-week of the intervention.
| Arm | Type | Receives |
|---|---|---|
| Cold Water Immersion | Experimental | Behavioral: Cold Water ImmersionThe 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. |
| No Intervention | No intervention | –The participants would not receive Cold Water Intervention. However, they are allowed to received the usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- People with gouty arthritis in the knee or ankle or metatarsophalangeal or metacarpophalangeal or olecranon bursa or wrist
- Participants were Indonesian nationals aged ≥18 years
- They had visited a clinic of the Public CHS of Tomohon City
- They had agreed to participate in the study.
Key exclusion criteria (1 listed)
- Participants who self-reported the presence of other types of inflammatory arthritis, including RA or spondyloarthritis
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 |
|---|---|---|
| Cold Water ImmersionThe 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. | Behavioural | Cold Water Immersion |
Primary outcome
Pain Level assessed by The Visual Analog Scale (VAS) at the baseline
Time frame: Baseline/ pre-intervention
Pain Level assessed by the Visual Analog Scale (VAS) instrument that has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
Pain Level assessed by The Visual Analog Scale (VAS) at the 2nd week/during the intervention
Time frame: 2nd week/during the intervention
Pain Level assessed by The Visual Analog Scale (VAS) instrument that has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
Pain Level assessed by the Visual Analog Scale (VAS) at 4th week/immediately after intervention
Time frame: 4th week/immediately after intervention
Pain Level assessed by the Visual Analog Scale (VAS) instrument has 10 centimeters length. The standard scale anchored by "no pain" marked as a score of 0 and the "worst imaginable pain" marked as a score of 10 cm (Huskisson et al., 1974; Scott \& Huskisson, 1976). The higher score identifies greater pain intensity. The reliability test showed that VAS was good (r = 0.94, p = 0.001) (Ferraz et al., 1990). The reliability test of the VAS instrument has been done in Indonesia with the Cronbach's alpha as 0.89 (Suwendar et al., 2017)
12 secondary outcomes
Joint mobility assessed by Goniometry at the baseline
Time frame: Baseline/ pre-intervention
Joint mobility assessed by Goniometry at the 2nd week/during the intervention
Time frame: 2nd week/during the intervention
Joint mobility assessed by Goniometry at the 4th week/immediately after intervention
Time frame: 4th week/immediately after intervention
Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the baseline
Time frame: Baseline/ pre-intervention
Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the 2nd week/during the intervention
Time frame: 2nd week/during the intervention
Stress, anxiety, depression assessed by the Depression Anxiety Stress Scale at 4th week/immediately after intervention
Time frame: 4th week/immediately after intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire at Baseline
Time frame: Baseline, pre-intervention
Quality of Life (QOL) level assessed by 36 Health Survey (SF-36) questionnaire 2nd week/during the intervention
Time frame: 2nd week/during the intervention
Quality of Life (QOL) level assessed by36 Health Survey (SF-36) questionnaire 4th week/immediately after intervention
Time frame: 4th week/immediately after intervention
Physical activity (MET-h/week) level assessed by questions based on the modified Physical Activity Guideline at the baseline
Time frame: Baseline, pre-intervention
Physical activity (MET-h/week) level assessed by questions based on the modified Physical Activity Guideline at 2nd week/during the intervention
Time frame: 2nd week/during the intervention
Physical activity (MET-h/week) level: Change from Baseline and 2nd week time point
Time frame: 4th week/immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 29272507Abhishek A, Doherty M. Education and non-pharmacological approaches for gout. Rheumatology (Oxford). 2018 Jan 1;57(suppl_1):i51-i58. doi: 10.1093/rheumatology/kex421.
- Background: PubMed 22336838Bleakley C, McDonough S, Gardner E, Baxter GD, Hopkins JT, Davison GW. Cold-water immersion (cryotherapy) for preventing and treating muscle soreness after exercise. Cochrane Database Syst Rev. 2012 Feb 15;2012(2):CD008262. doi: 10.1002/14651858.CD008262.pub2.
- Background: PubMed 26138016Burke BT, Kottgen A, Law A, Windham BG, Segev D, Baer AN, Coresh J, McAdams-DeMarco MA. Physical Function, Hyperuricemia, and Gout in Older Adults. Arthritis Care Res (Hoboken). 2015 Dec;67(12):1730-8. doi: 10.1002/acr.22648.
- BackgroundAlbar, Z. (2007). Gout: Diagnosis and management. Medical Journal of Indonesia, 16(1), 47-54. https://doi.org/10.13181/mji.v16i1.256
- BackgroundAmanah, A., Komala, I., Kurniasari, M. D., Dharmana, E., & Gasem, M. H. (2018). Effect of Mangosteen ( Garcinia mangostana ) PEEL Extract towards CD4 + , CD8 + T LYMPHOCYTES , CD38 Expression , NK Cells , IL-2 and IFN γ in Hiv Patients with Antiretroviral Therapy. Hiroshima Journal of Medical Sciences, 67(24), 56-62.
- Background: PubMed 29734124Carroll M, Boocock M, Dalbeth N, Stewart S, Frampton C, Rome K. Ankle joint function during walking in tophaceous gout: A biomechanical gait analysis study. Gait Posture. 2018 Jun;63:150-153. doi: 10.1016/j.gaitpost.2018.04.020. Epub 2018 Apr 17.
- Background: PubMed 26245722Chandratre P, Mallen CD, Roddy E, Liddle J, Richardson J. "You want to get on with the rest of your life": a qualitative study of health-related quality of life in gout. Clin Rheumatol. 2016 May;35(5):1197-205. doi: 10.1007/s10067-015-3039-2. Epub 2015 Aug 6.
- Background: PubMed 29398125Chandratre P, Mallen C, Richardson J, Muller S, Hider S, Rome K, Blagojevic-Bucknall M, Roddy E. Health-related quality of life in gout in primary care: Baseline findings from a cohort study. Semin Arthritis Rheum. 2018 Aug;48(1):61-69. doi: 10.1016/j.semarthrit.2017.12.005. Epub 2018 Jan 5.
- Background: PubMed 23252362DiBonaventura Md, Andrews LM, Yadao AM, Kahler KH. The effect of gout on health-related quality of life, work productivity, resource use and clinical outcomes among patients with hypertension. Expert Rev Pharmacoecon Outcomes Res. 2012 Dec;12(6):821-9. doi: 10.1586/erp.12.60.
- Background: PubMed 4413123Dorwart BB, Hansell JR, Schumacher HR Jr. Effects of cold and heat on urate crystal-induced synovitis in the dog. Arthritis Rheum. 1974 Sep-Oct;17(5):563-71. doi: 10.1002/art.1780170510. No abstract available.
- Background: PubMed 2213777Ferraz MB, Quaresma MR, Aquino LR, Atra E, Tugwell P, Goldsmith CH. Reliability of pain scales in the assessment of literate and illiterate patients with rheumatoid arthritis. J Rheumatol. 1990 Aug;17(8):1022-4.
- Background: PubMed 30447743Fields TR. The Challenges of Approaching and Managing Gout. Rheum Dis Clin North Am. 2019 Feb;45(1):145-157. doi: 10.1016/j.rdc.2018.09.009.
- 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.
Hsiu Ting Tsai, PhD study director
Taipei Medical 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 Cold Water Immersion in people with Gout Arthritis, run by Taipei Medical University at 1 site in Indonesia.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2021. 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 Indonesia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Level assessed by The Visual Analog Scale (VAS) at the baseline (time frame: Baseline/ pre-intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04587544, which also lists 45 linked publications.
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 17 Mar 2021.