Clinical trial NCT03571009: Real-time Pain Monitoring in Fibromyalgia Patients
Official title: Utilization of Real-time Pain Monitoring System (PAMS), ANAPA System, in Patients With Rheumatic Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Fibromyalgia
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 25
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Chronic pain is difficult to treat and is debilitating to patients in various ways, including wide spread suffering, disability, social displacement, and expense. For effective pain management, the first step should be to assess the exact status of the pain. This process may include characterizing the pain, quantifying it as accurately as possible, and analyzing influencing factors. However, it is hard to objectify pain because it is an invisible and subjective. The visual analogue scale (VAS) is widely used to assess the severity of pain. Moreover, current management of chronic pain is based on a patient's recall, which may be inaccurate. It would be ideal if we could manage pain by recording its status on a real-time basis, reflecting the impact of environmental factors. The Pain Assessment and Analysis System (PAAS) has been developed to monitor and record real-time pain. Users are asked to report the type of experienced pain and its severity. Therefore, for user convenience, PAAS can be accessed using a wearable device (Painmeter, LST, Seoul, Korea) that is interlinked with a smartphone mobile application (DrKooB-PAAS, iKooB Inc. Seoul, South Korea). The system records the frequency and severity of pain and can create reports summarizing the pain over the course of various time intervals. In addition, this system also records the time, temperature, humidity, and weather, along with the reported pain, to determine any correlations between the pain and these environmental factors. Fibromyalgia (FMS) is a complex disorder characterized by intractable, widespread pain and somatic symptoms such as insomnia, constipation, diarrhea, and cognitive dysfunction. The exact pathogenesis has yet to be elucidated, but current understandings suggest that disturbances in pain-regulating neurotransmitters are involved. The diagnosis and management of FMS are a challenge for physicians. Its management should combine pharmacological and non-pharmacological approaches, which suggests there are various factors that influence treatment outcomes. To date, tricyclic agents, serotonin norepinephrine reuptake inhibitors, and pregabalin are known to have beneficial effects; however, a substantial number of patients are still suffering from the uncontrolled pain of FMS.

To address the pain in these patients, an appropriate pain monitoring system that can reflect real-time pain severity and frequency and can analyze the pattern of impacting factors can be used to provide effective treatment and to eventually improve patient pain. Therefore, we aimed to investigate the feasibility of a real-time pain monitoring system, the Pain Assessment and Analysis System (PAAS), in patients with FMS in order to evaluate its effect on pain reduction. In addition, we evaluated the correlations between the VAS measured by PAAS and clinical parameters reflecting the disease activity of FMS.

Eligibility criteria: * 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

Primary outcomes:
measure: Changes in Pain visual analogue scale
timeFrame: 3 months after randomization
Secondary outcomes:
measure: Changes in the dose of medication
timeFrame: 3 months after baseline visit
measure: Changes in the disease activity
timeFrame: 3 months after baseline visit
measure: Changes in the quality of life
timeFrame: 3 months after baseline visit
measure: Changes in the depressive symptoms
timeFrame: 3 months after baseline visit
measure: Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with patient global assessment
timeFrame: 1 month after baseline visit
measure: Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with disease activity
timeFrame: 1 month after baseline visit
measure: Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with physician global assessment
timeFrame: 1 month after baseline visit
Other outcomes:
Locations:
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Ji Hyeon Ju, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: