Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03571009
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2018-06-04
Brief Title:
Real-time Pain Monitoring in Fibromyalgia Patients
Sponsor:
Ji Hyeon Ju
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Utilization of Real-time Pain Monitoring System PAMS ANAPA System in Patients With Rheumatic Disease
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None