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

NCT04587544 | Completed

• 1 other identifier: N201912052
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout Arthritis

Keywords

Gout Arthritis; Cold Water Immersion; Pain

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  4th week/immediately after intervention

Secondary Outcomes (12)

• Joint mobility assessed by Goniometry at the baseline

  Baseline/ pre-intervention

• Joint mobility assessed by Goniometry at the 2nd week/during the intervention

  2nd week/during the intervention

• Joint mobility assessed by Goniometry at the 4th week/immediately after intervention

  4th week/immediately after intervention

• Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the baseline

  Baseline/ pre-intervention

• Stress, anxiety, depression assessed by The Depression Anxiety Stress Scale questionnaire at the 2nd week/during the intervention

  2nd week/during the intervention

Study Arms (2)

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.

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

Interventions

Cold Water Immersion BEHAVIORAL

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.

Cold Water Immersion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who self-reported the presence of other types of inflammatory arthritis, including RA or spondyloarthritis

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Rendra

Tomohon, North Celebes, 95446, Indonesia

Location

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MeSH Terms

Conditions

Arthritis, Gouty; Pain

Condition Hierarchy (Ancestors)

Gout; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hsiu Ting Tsai, PhD

  Taipei Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is only possible to blind the evaluator of the study. The evaluator is blinded the group division either treatment or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: College of Nursing, Taipei Medical University, Taipei, Taiwan, R.O.C.

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2020
• First Posted: October 14, 2020
• Study Start: July 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 31, 2021
• Last Updated: March 17, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)