Pain Clinical Trial
Official title:
Utilization of Real-time Pain Monitoring System (PAMS), ANAPA System, in Patients With Rheumatic Disease
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.
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.
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