Chronic Pain SyndromeNCT04235218
Brief-Illness Perception Questionnaire (Brief-IPQ) Used in Patients With Chronic Non-malignant Pain.
An observational study of Chronic Pain Syndrome, run by Zealand University Hospital.
Trial summary
We wish to clarify whether we can demonstrate a correlation between scores in Brief-IPQ and the effect of treatment in patients referred to our department, Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Chronic Pain Syndrome
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2022to 1 Feb 2023
- Phase
- Observational
- 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 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with chronic non-malignant pain conditions reffered to the multidisciplinary pain clinic
Who may be able to join
- age 18 years old or older
- speak and understand written danish sufficiently to participate in the study.
Who cannot join
- Patients who have insufficient cognitive abilities to answer the questions in Brief-IPQ and PainDATA. Patients who dont want to participate in the study. Patients who answer the questions in Brief-IPQ and PainDATA incompletly.
About this study
Official title: Brief-Illness Perception Questionnaire (Brief-IPQ) Used as Prediction of Outcome in Patients With Chronic Non-malignant Pain After Six Months of Treatment in a Multidicsiplinary Pain Clinic.
We wish to clarify whether we can demonstrate a correlation between scores in Brief-IPQ and the effect of treatment in patients referred to our department, Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark. The purpose is to outline whether we can use Brief-IPQ with Chronic Pain disorders and thereby detect those of our referred patients who are at risk for poor treatment response in an early state. In these cases, we can offer psychological intervention at the beginning of the course of treatment, in order to optimize the conditions for patients and achieve an optimal treatment effect.
Read the detailed description
Chronic pain conditions are frequent in the danish population. More than 1.2 million Danes over the age of 16 are living with chronic pain. Chronic pain affects the health-related quality of life and functioning and is associated with reduced work ability, lost earnings and disability. At the Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark, patients with chronic pain are received and treated based on the Bio-Psycho-Social Pain Model. The treatment of patients with complex chronic non-malignant pain can be complicated by psychological and / or social factors. The need for a screening of psychological factors in connection with the examination and planning of the pain management in the Interdisciplinary Pain Center is obvious as the patient's perception of illness and expectation of treatment have been shown to play a role in the treatment response. The Brief Illness Perception Questionnaire (Brief-IPQ) provides a quick assessment of the patient's disease perception and expectation of treatment and has proved useful in clinical practice. In this study, a Danish version of Brief-IPQ is used, which initially was taken from https://www.uib.no. Items as stated in research by L. van Oort et al (2011) have been adapted to the Danish version. A copy of the latest version can be obtained from Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark.
The Study:
The study is designed as a prospective observational study of the correlation between Brief-IPQ and pain-related and demographic data in patients referred to Interdisciplinary Pain Center Zealand University Hospital Køge, Denmark. Brief IPQ and PainData (which is a database which records the well-being of Danish pain patients and operated by "Danske Regioner" and Odense University Hospital) is measured at the start of treatment and after 6 months. They will consists of items such as; Married or cohabitant, Vocational training, Educational length, Occupational status. There will furthermore be an assessment of pain type such as; nociceptive / neurogenic / generalized / visceral / other as well as the duration of symptoms and treatment with opioids: +/-, equipotent daily doses. Additionally we focus on Pain intensity (NRS) from Paindata, Psychological profile (from Paindata): anxiety, depression, stress, fear-avoidance, self-efficacy and the following changes before and after six months of treatment:
Inclusion:
All patients referred to Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark and start the treatment from the start date of the study can be included in the study provided:
- Age over 18 years
- Understands and speaks Danish
Exclusion:
Patients who meet one of the following criteria are not eligible for inclusion in this study:
- Patients who do not have sufficient cognitive skills to complete the form (Brief-IPQ)
- Patients who cannot cooperate to complete the form (Brief-IPQ)
- Patients who submit invalid or illegible answers (Brief-IPQ)
Number of patients needed:
60 patients with complete data or number included as of May 1, 2020. Time schedule: Collection of data: start February 1.2020 End: when complete data has been obtained from 60 patients, or no later than 1.12.2020
Ethical aspects:
All information will be treated confidentially and all data will be anonymized by a secretary. The Investigator will keep an identification list of all patients who have been included. This list will include the patient's full name and CPR number. Collected data will be recorded in a Case Report Form. The results will be stored and analyzed using a computer and the anonymity of the patients will be preserved and local data law will be observed. Data will be stored in accordance with existing regulations. Data is stored in anonymized form and correlation and regression analysis will be performed after 6 months. The study is conducted in accordance with applicable clinical trial rules. Investigators are responsible for the handling and archiving of data in accordance with applicable rules in addition to the Act on the Processing of Personal Data and the Health Act. Data belong to the investigators. The project has been reported to the local ethic committee.
- Conditions
- Chronic Pain Syndrome
- Keywords
- non-malignant pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Brief-IPQ before and after six months of treatment in a multidisciplinary pain clinic
The changes will be correlated to the following variables: pain intensity, use of opioids and self reported symptoms related to anxiety, depression, stress, fear-avoidence and self-efficacy.
Measured: six months
Secondary outcomes (1)
Influence of demographic factors on Brief-IPQ score
gener, age, education, duration of pain
Measured: During the enrollment. Will be blinded to the investigators untill after the collection of data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start20 May 2022 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Feb 2023 (estimated)
Why it stopped: Corona pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain SyndromeStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235218
- Sponsor's protocol ID
- REG-081-2019
- Status last verified
- Jun 2021
- First submitted
- 15 Jan 2020
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief-Illness Perception Questionnaire (Brief-IPQ) Used as Prediction of Outcome in Patients With Chronic Non-malignant Pain After Six Months of Treatment in a Multidicsiplinary Pain Clinic.
- ClinicalTrials.gov ID
- NCT04235218
- Acronym / sponsor ID
- REG-081-2019
- Conditions
- Chronic Pain Syndrome
- Keywords
- non-malignant pain
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Corona pandemic
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Feb 2023 (estimated)
- First posted
- 21 Jan 2020 (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.
We wish to clarify whether we can demonstrate a correlation between scores in Brief-IPQ and the effect of treatment in patients referred to our department, Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark. The purpose is to outline whether we can use Brief-IPQ with Chronic Pain disorders and thereby detect those of our referred patients who are at risk for poor treatment response in an early state. In these cases, we can offer psychological intervention at the beginning of the course of treatment, in order to optimize the conditions for patients and achieve an optimal treatment effect.
Detailed description
Chronic pain conditions are frequent in the danish population. More than 1.2 million Danes over the age of 16 are living with chronic pain. Chronic pain affects the health-related quality of life and functioning and is associated with reduced work ability, lost earnings and disability. At the Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark, patients with chronic pain are received and treated based on the Bio-Psycho-Social Pain Model. The treatment of patients with complex chronic non-malignant pain can be complicated by psychological and / or social factors. The need for a screening of psychological factors in connection with the examination and planning of the pain management in the Interdisciplinary Pain Center is obvious as the patient's perception of illness and expectation of treatment have been shown to play a role in the treatment response. The Brief Illness Perception Questionnaire (Brief-IPQ) provides a quick assessment of the patient's disease perception and expectation of treatment and has proved useful in clinical practice. In this study, a Danish version of Brief-IPQ is used, which initially was taken from https://www.uib.no. Items as stated in research by L. van Oort et al (2011) have been adapted to the Danish version. A copy of the latest version can be obtained from Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark.
The Study:
The study is designed as a prospective observational study of the correlation between Brief-IPQ and pain-related and demographic data in patients referred to Interdisciplinary Pain Center Zealand University Hospital Køge, Denmark. Brief IPQ and PainData (which is a database which records the well-being of Danish pain patients and operated by "Danske Regioner" and Odense University Hospital) is measured at the start of treatment and after 6 months. They will consists of items such as; Married or cohabitant, Vocational training, Educational length, Occupational status. There will furthermore be an assessment of pain type such as; nociceptive / neurogenic / generalized / visceral / other as well as the duration of symptoms and treatment with opioids: +/-, equipotent daily doses. Additionally we focus on Pain intensity (NRS) from Paindata, Psychological profile (from Paindata): anxiety, depression, stress, fear-avoidance, self-efficacy and the following changes before and after six months of treatment:
Inclusion:
All patients referred to Interdisciplinary Pain Center Zealand University Hospital Koege, Denmark and start the treatment from the start date of the study can be included in the study provided:
- Age over 18 years
- Understands and speaks Danish
Exclusion:
Patients who meet one of the following criteria are not eligible for inclusion in this study:
- Patients who do not have sufficient cognitive skills to complete the form (Brief-IPQ)
- Patients who cannot cooperate to complete the form (Brief-IPQ)
- Patients who submit invalid or illegible answers (Brief-IPQ)
Number of patients needed:
60 patients with complete data or number included as of May 1, 2020. Time schedule: Collection of data: start February 1.2020 End: when complete data has been obtained from 60 patients, or no later than 1.12.2020
Ethical aspects:
All information will be treated confidentially and all data will be anonymized by a secretary. The Investigator will keep an identification list of all patients who have been included. This list will include the patient's full name and CPR number. Collected data will be recorded in a Case Report Form. The results will be stored and analyzed using a computer and the anonymity of the patients will be preserved and local data law will be observed. Data will be stored in accordance with existing regulations. Data is stored in anonymized form and correlation and regression analysis will be performed after 6 months. The study is conducted in accordance with applicable clinical trial rules. Investigators are responsible for the handling and archiving of data in accordance with applicable rules in addition to the Act on the Processing of Personal Data and the Health Act. Data belong to the investigators. The project has been reported to the local ethic committee.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with chronic non-malignant pain conditions reffered to the multidisciplinary pain clinic
Key inclusion criteria (2 listed)
- age 18 years old or older
- speak and understand written danish sufficiently to participate in the study.
Key exclusion criteria (1 listed)
- Patients who have insufficient cognitive abilities to answer the questions in Brief-IPQ and PainDATA. Patients who dont want to participate in the study. Patients who answer the questions in Brief-IPQ and PainDATA incompletly.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in Brief-IPQ before and after six months of treatment in a multidisciplinary pain clinic
Time frame: six months
The changes will be correlated to the following variables: pain intensity, use of opioids and self reported symptoms related to anxiety, depression, stress, fear-avoidence and self-efficacy.
1 secondary outcome
Influence of demographic factors on Brief-IPQ score
Time frame: During the enrollment. Will be blinded to the investigators untill after the collection of data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain Syndrome, run by Zealand University Hospital.
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 2 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: withdrawn, as of the sponsor's last update on 8 Mar 2022. 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 was withdrawn before enrolling participants, so there are no results.
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 Brief-IPQ before and after six months of treatment in a multidisciplinary pain clinic (time frame: six months). 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 8 Mar 2022.