PainpainNCT03117075
The Efficacy of Pain Management With Self-reporting Pain Monitoring System in Cancer Patient
A study testing using device for scoring pain scale, named "ANAPA®" in people with Pain, run by DERSHENG SUN at 2 sites in South Korea.
Trial summary
To compare the pain scales between clinician evaluated and reported with wearable device by patients. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain
- What is being tested?
- using device for scoring pain scale, named "ANAPA®"
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 15 May 2017to 14 Apr 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 20 year old
- cancer pain with visual analog scale or numeric rating scale score >/- 4
- opioids candidates
- with informed consent form
Who cannot join
- life expectancy within 3 months
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Daejeon St. Mary's Hospital, the Catholic University of Korea
Daejeon
Seoul St. Mary's Hospital, the Catholic University of Korea
Seoul, 06591
About this study
Official title: The Efficacy of Pain Management With Self-reporting Pain Monitoring
To compare the pain scales between clinician evaluated and reported with wearable device by patients.
Read the detailed description
To compare the pain scales between clinician evaluated and reported with wearable device by patients with cancer of advanced stage.
- Conditions
- Pain
- Being tested
- using device for scoring pain scale, named "ANAPA®"
- Keywords
- cancer pain, wearable device
- Medical subject headings
- Pain, Cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
using device for scoring pain scale, named "ANAPA®"Device
wearable device for scoring pain scale
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | using device for scoring pain scale, named "ANAPA®" Receives: Device: using device for scoring pain scale, named "ANAPA®" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actual difference of pain scales
comparing the pain scale assessed by wearable device and that assessed by physician when out patient clinic.
Measured: 1 week after using wearable pain scale device - baseline and 1 week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start15 May 2017 (estimated)
- Primary completion14 Nov 2017 (estimated)
- Study completion14 Apr 2018 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DERSHENG SUN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DERSHENG SUN, The Catholic University of Korea
- Investigators
- YOONHO KO, MD, PhD, Principal investigator, Uijeongbu St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117075
- Sponsor's protocol ID
- XC15EIMI0099KUD
- Acronym
- pain
- Status last verified
- Apr 2017
- First submitted
- 19 Jan 2016
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Pain Management With Self-reporting Pain Monitoring
- ClinicalTrials.gov ID
- NCT03117075
- Acronym / sponsor ID
- pain / XC15EIMI0099KUD
- Conditions
- Pain
- Keywords
- cancer pain, wearable device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- DERSHENG SUNUniversity, hospital or other
- Study start
- 15 May 2017 (estimated)
- Primary completion
- 14 Nov 2017 (estimated)
- Study completion
- 14 Apr 2018 (estimated)
- First posted
- 17 Apr 2017 (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.
To compare the pain scales between clinician evaluated and reported with wearable device by patients.
Detailed description
To compare the pain scales between clinician evaluated and reported with wearable device by patients with cancer of advanced stage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: using device for scoring pain scale, named "ANAPA®"using device for scoring pain scale, named "ANAPA®" |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- over 20 year old
- cancer pain with visual analog scale or numeric rating scale score >/- 4
- opioids candidates
- with informed consent form
Key exclusion criteria (1 listed)
- life expectancy within 3 months
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 |
|---|---|---|
| using device for scoring pain scale, named "ANAPA®"wearable device for scoring pain scale | Device | Experimental |
Primary outcome
Actual difference of pain scales
Time frame: 1 week after using wearable pain scale device - baseline and 1 week.
comparing the pain scale assessed by wearable device and that assessed by physician when out patient clinic.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
- Individual participant dataSharing planned: No
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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.
YOONHO KO, MD, PhD principal investigator
Uijeongbu St. Mary's Hospital, The Catholic University of Korea
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing using device for scoring pain scale, named "ANAPA®" in people with Pain, run by DERSHENG SUN at 2 sites in South Korea.
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 4 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DERSHENG SUN, MD, PhD (+82-31-820-3584, ds-sun@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actual difference of pain scales (time frame: 1 week after using wearable pain scale device - baseline and 1 week.). 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 17 Apr 2017.