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临床试验/NCT03571009
NCT03571009已完成不适用

Utilization of Real-time Pain Monitoring System (PAMS), ANAPA System, in Patients With Rheumatic Disease

Ji Hyeon Ju0 个研究点目标入组 25 人开始时间: 2015年12月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
25
主要终点
Changes in Pain visual analogue scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

utilization of PAAS

Experimental

conventional treatment utilization of PAAS

干预措施: utilization of PAAS (Device)

Conventional care

No Intervention

conventional treatment only

结局指标

主要结局

Changes in Pain visual analogue scale

时间窗: 3 months after randomization

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.

次要结局

  • Changes in the quality of life(3 months after baseline visit)
  • Changes in the disease activity(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)
  • Changes in the dose of medication(3 months after baseline visit)
  • Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with disease activity(1 month 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 physician global assessment(1 month after baseline visit)

研究者

发起方
Ji Hyeon Ju
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ji Hyeon Ju

Professor

Seoul St. Mary's Hospital

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