Real-time Pain Monitoring in Fibromyalgia Patients

NCT03571009 | Completed

• 1 other identifier: PAAS in FMS
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Pain; Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Changes in the dose of medication

  3 months after baseline visit

• Changes in the disease activity

  3 months after baseline visit

• Changes in the quality of life

  3 months after baseline visit

• Changes in the depressive symptoms

  3 months after baseline visit

• Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with patient global assessment

  1 month after baseline visit

Study Arms (2)

utilization of PAAS

EXPERIMENTAL

conventional treatment utilization of PAAS

Device: utilization of PAAS

Conventional care

NO INTERVENTION

conventional treatment only

Interventions

utilization of PAAS DEVICE

utilization of real-time pain assessment and analysis system (PAAS) consists of wearing device and reporting a real-time pain using the device

utilization of PAAS

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older diagnosed with fibromyalgia based on the 2010 American College of Rheumatology preliminary diagnostic criteria for FMS

You may not qualify if:

• previously diagnosed with a serious systemic medical illness a medical condition that can affect bodily pain: eg. (1) inflammatory arthritis (2) malignancy

Sponsors & Collaborators

• Ji Hyeon Ju: lead

MeSH Terms

Conditions

Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Ji Hyeon Ju, MD PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: The patients were supposed to complete three visits (baseline, one month, and three months). Patients in the PAAS group were provided with a wearable device (Painmeter, LST, Seoul, Korea) and smartphone application (DrKooB-PAAS, iKooB Inc. Seoul, South Korea), while the control group was provided conventional treatment without using the system. After screening, patients were randomly assigned to a group with an opaque envelope that contained the written randomization result. After completing the three months of the study, patients in the control group were then allocated to the PAAS group and underwent three additional months of study.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: June 27, 2018
• Study Start: December 22, 2015
• Primary Completion: November 30, 2016
• Study Completion: September 21, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06