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PainNCT03571009

Real-time Pain Monitoring in Fibromyalgia Patients

A study testing utilization of PAAS in people with Pain and Fibromyalgia, run by Ji Hyeon Ju.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Pain, Fibromyalgia
What is being tested?
utilization of PAAS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
22 Dec 2015to 21 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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.

Read the 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.

Conditions
Pain, Fibromyalgia
Being tested
utilization of PAAS
Medical subject headings
Pain, Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • utilization of PAASDevice

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

Study groups in NCT03571009
Study groupRoleWhat they receive
utilization of PAASExperimentalconventional treatment utilization of PAAS
Receives: Device: utilization of PAAS
Conventional careNo interventionconventional treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months after randomization

Secondary outcomes (7)
  1. Changes in the dose of medication

    To address the dose and the class of the medication

    Measured: 3 months after baseline visit

  2. Changes in the disease activity

    Fibromyalgia impact questionnaire is used to address the disease activity

    Measured: 3 months after baseline visit

  3. Changes in the quality of life

    Euro QoL - 5D questionnaire is used to address hearth related quality of life

    Measured: 3 months after baseline visit

  4. Changes in the depressive symptoms

    Beck's depression index is used to address the severity of depressive symptoms

    Measured: 3 months after baseline visit

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

    correlation between PAAS VAS and patient global assessment (0-10 mm)

    Measured: 1 month after baseline visit

  6. Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with disease activity

    correlation between PAAS VAS and Fibromyalgia impact questionnaire scores

    Measured: 1 month after baseline visit

  7. Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with physician global assessment

    correlation between PAAS VAS and physician global assessment (0-10 mm)

    Measured: 1 month after baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2018
  2. Study start22 Dec 2015
  3. Primary completion30 Nov 2016
  4. Study completion21 Sep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
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.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571009
Sponsor's protocol ID
PAAS in FMS
Status last verified
Jun 2018
First submitted
4 Jun 2018
Last updated
27 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing utilization of PAAS in people with Pain and Fibromyalgia, run by Ji Hyeon Ju.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Pain visual analogue scale (time frame: 3 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.

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