Pain Clinical Trial
Official title:
Utilization of Real-time Pain Monitoring System (PAMS), ANAPA System, in Patients With Rheumatic Disease
Verified date | June 2018 |
Source | Seoul St. Mary's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study aims to examine whether the pain of fibromyalgia patients can be reduced with utilization of real-time pain monitoring system (PAAS). In this pilot study, adult fibromyalgia patients were randomly assigned to use or to not use PAAS. Changes in the visual analogue scale (VAS) were examined by rheumatologists at baseline and after three months, and correlations between conventional pain VAS or PAAS VAS and clinical parameters (patient global assessment, physician global assessment, fibromyalgia impact questionnaire) were investigated. We also examined if the utilization of PAAS can affect health related quality of life and depression.
Status | Completed |
Enrollment | 25 |
Est. completion date | September 21, 2017 |
Est. primary completion date | November 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
- Inclusion Criteria: 19 years of age or older diagnosed with fibromyalgia based on the 2010 American College of Rheumatology preliminary diagnostic criteria for FMS - Exclusion Criteria: previously diagnosed with a serious systemic medical illness a medical condition that can affect bodily pain: eg. (1) inflammatory arthritis (2) malignancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ji Hyeon Ju |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in Pain visual analogue scale | The pain visual analogue scale (0-10 mm) of the patient is addressed on each visit. Changes in pain visual analogue scale on 3 months visit is evaluated. | 3 months after randomization | |
Secondary | Changes in the dose of medication | To address the dose and the class of the medication | 3 months after baseline visit | |
Secondary | Changes in the disease activity | Fibromyalgia impact questionnaire is used to address the disease activity | 3 months after baseline visit | |
Secondary | Changes in the quality of life | Euro QoL - 5D questionnaire is used to address hearth related quality of life | 3 months after baseline visit | |
Secondary | Changes in the depressive symptoms | Beck's depression index is used to address the severity of depressive symptoms | 3 months after baseline visit | |
Secondary | Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with patient global assessment | correlation between PAAS VAS and patient global assessment (0-10 mm) | 1 month after baseline visit | |
Secondary | Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with disease activity | correlation between PAAS VAS and Fibromyalgia impact questionnaire scores | 1 month after baseline visit | |
Secondary | Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with physician global assessment | correlation between PAAS VAS and physician global assessment (0-10 mm) | 1 month after baseline visit |
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