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.
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 group | Role | What they receive |
|---|---|---|
| utilization of PAAS | Experimental | conventional treatment utilization of PAAS Receives: Device: utilization of PAAS |
| Conventional care | No intervention | conventional treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Changes in the dose of medication
To address the dose and the class of the medication
Measured: 3 months after baseline visit
Changes in the disease activity
Fibromyalgia impact questionnaire is used to address the disease activity
Measured: 3 months after baseline visit
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
Changes in the depressive symptoms
Beck's depression index is used to address the severity of depressive symptoms
Measured: 3 months after baseline visit
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
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
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.
- First posted27 Jun 2018
- Study start22 Dec 2015
- Primary completion30 Nov 2016
- Study completion21 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ji Hyeon Ju
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ji Hyeon Ju, Seoul St. Mary's Hospital
- Investigators
- Ji Hyeon Ju, MD PhD, Principal investigator, Seoul St. Mary's Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of Real-time Pain Monitoring System (PAMS), ANAPA System, in Patients With Rheumatic Disease
- ClinicalTrials.gov ID
- NCT03571009
- Acronym / sponsor ID
- PAAS in FMS
- Conditions
- Pain, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ji Hyeon JuUniversity, hospital or other
- Study start
- 22 Dec 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 21 Sep 2017 (actual)
- First posted
- 27 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| utilization of PAAS | Experimental | Device: utilization of PAASconventional treatment utilization of PAAS |
| Conventional care | No intervention | –conventional treatment only |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 19 years of age or older diagnosed with fibromyalgia based on the 2010 American College of Rheumatology preliminary diagnostic criteria for FMS
Key exclusion criteria (1 listed)
- previously diagnosed with a serious systemic medical illness a medical condition that can affect bodily pain: eg. (1) inflammatory arthritis (2) malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| utilization of PAASutilization of real-time pain assessment and analysis system (PAAS) consists of wearing device and reporting a real-time pain using the device | Device | utilization of PAAS |
Primary outcome
Changes in Pain visual analogue scale
Time frame: 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.
7 secondary outcomes
Changes in the dose of medication
Time frame: 3 months after baseline visit
Changes in the disease activity
Time frame: 3 months after baseline visit
Changes in the quality of life
Time frame: 3 months after baseline visit
Changes in the depressive symptoms
Time frame: 3 months after baseline visit
Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with patient global assessment
Time frame: 1 month after baseline visit
Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with disease activity
Time frame: 1 month after baseline visit
Correlation of pain visual analogue scale (VAS) by pain assessment analysis system (PAAS) with physician global assessment
Time frame: 1 month after baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Hyeon Ju, MD PhD principal investigator
Seoul St. Mary's Hospital
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.