Brief-Illness Perception Questionnaire (Brief-IPQ) Used in Patients With Chronic Non-malignant Pain

Chronic Pain Clinical Trial

Official title:

Brief-Illness Perception Questionnaire (Brief-IPQ) Used as Prediction of Outcome in Patients With Chronic Non-malignant Pain After Treatment in a Multidisciplinary Pain Clinic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535335
• Other study ID #: REG-1303-2022
• Status: Completed
• Start date: June 6, 2020
• Est. completion date: April 3, 2022

Study information

• Verified date: March 2022
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators wish to investigate if there are any difference in the BIPQ score in persons with chronic low back pain from admission to the Pain Centre at Zealand University Hospital Koege (ZUH), and when discharged.

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:

Participants:

Patients with chronic low back pain admitted to the Pain Centre after June 2021 at ZUHK.

• Persons ≥18 years

• Persons who suffers from chronic back pain and are admitted to the Pain Centre at Zealand University Hospital in Køge, Denmark

• Persons who have completed the BIPQ both at first and at last visit in the Pain Centre

Numbers 100 patients with both pre and post admission IBPQ score

Timeframe The data will be analyzed when there is a full dataset on 100 patients admitted from June 2020

Location of the study The Pain Centre at Zealand University Hospital, Koege

The patients will answer the questionnaire including the following data online before visiting the pain Centre and after treatment. Thereby the investigators can estimate the result of treatment compared to the BIPQ score before entry to treatment statistically. and thereby generate estimates concerning the success of pain treatment measured by BIPQ.

• The Pain Self-Efficacy Questionnaire (PSEQ) is a 10-item questionnaire, to assess the confidence people with ongoing pain have in performing activities while in pain.

• Pain during movement is measured by the Numeric Rating Scale (NRS) from 0 to 10

• For measuring the patients fear of movement related pain (fear avoidance) the 17 items questionnaire Tampa Scale of Kinesiophobia (TSK) will be used.

0= No pain at all and 10= worse imaginable pain

• Pain catastrophizing is measured by the Pain Catastrophizing Scale (PCS) and includes the following items rumination ("I can't stop thinking about how much it hurts"), magnification ("I worry that something serious may happen"), and helplessness ("There is nothing I can do to reduce the intensity of the pain"). The PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.

• Placebo measured with BIPQ. The BIPQ investigates the following; cognitive meaning (consequences, time perspective, personally control, treatment control and identity), emotional meaning (concerns, emotions), understanding of the condition and finally the patient´s own evaluation of the three most important reasons for the condition 8.

A decrease in BIPQ score will be defined as the mean +/- 1SD as cut-off.

All data will be derived from the PainData database. An examination is made of whether the patient meets the inclusion or exclusion criteria

• Data will be stored in an Excel file and the statistical analyses will performed using SPSS

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: April 3, 2022
• Est. primary completion date: April 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients admitted to the multidisciplinary pain clinic at Zealand University Hospital with low back pain

• Understand Danish spoken and written

Exclusion Criteria:

• Patients with insufficient cognitive abilities

• Patients who decline to participate in the study

Related Conditions & MeSH terms

• Chronic Pain
• Non-malignant Pain

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge	Zealand

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Differences in Fear Avoidance	Change in Fear avoidance will be measured by using the 17 items Tampa Scale of Kinesiophobia, Scores range from 17 to 68. Low scores indicate no kinesiophobia and high scores extreme fear of pain with movement. Cut off score = 37.	Change in Fear avoidance will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022
Other	Differences in Quality of life	Change in Quality of life will be measured by using the PROMIS-10 questionnaire.Using T-scores, median = 50, higher scores over 50 indicates wellbeeing.	Change in Quality of life will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022
Other	Differences in Pain Self efficacy	Change in Pain Self efficacy will be measured by using the 2 items fra 10 item questionnaire: PSEQ. PSEQ 1 and PSEQ 2. numbers are calculated by summing the numbers. Median = 3, Scores higher than 3 means high confidence, lower than 3 means low confidence.	Change in Pain Selv Efficacy will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022
Other	Differences in Pain Catastrophizing	Change in Pain Catastrophizing will be measured by using the 13 items Pain Catastrophizing Scale. PCS range from 0 to 52. Subclinical = 0 to 29; Mild = 30 to 39; Moderate = 40 to 49; Severe = 50 to 59; Extreme = 60 to 100.	Change in Pain Catastrophizing will be measured at admission and at discharge between the 12-6-2020 - 03-04-2022
Other	Differences in Numeric rating scale	Change in Pain intensity during movement measured from 0-10, where 10 is the worst pain	Change in Pain intensity during movement measured at admission and at discharge between the 12-6-2020 - 03-04-2022
Primary	Differences in illness perception	Change in Brief Illness perception will be measured by using the Brief Illness perception questionnaire. The IPQ-B consists of nine items rated on a scale from 0 (minimum) to 10 (maximum). Illness perception Scores 0-24, low scores, 24-56 moderate, 56- 80 high scores.	Change in Illness peception score Measured at admission and at discharge between the 12-6-2020 - 03-04-2022