Assessing Chronic Pain Patient Preferences (patientPREF)

Assessing Chronic Pain Patient Preferences Regarding the Analgesic Effect Relative to the Side Effects of Analgesic Drugs

The goal of this study is to ask chronic pain patients their preferences regarding which side effects of pain medications are least acceptable in relation to their pain relief benefits. This information may help in the selection of improved treatment options in the future.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Patient questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged over 18 years.
• Being treated with pain medication.
• (Chronic-)Pain for at least 3 months.
• Capacity to understand and provide an informed consent form.

Exclusion Criteria:

• Insufficient French or English language skills.
• Epilepsy treated by an anti-epileptic.
• Alzheimer's disease.
• Parkinson's disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Chronic pain patients	Other: Patient questionnaire; Online patient questionnaire that assesses multiple aspects such as current analgesic use, side effect burden, treatment satisfaction and patient preferences.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chronic pain patient preferences of pain medications regarding pain relief relative to the side effects using numeric rating scales (adaptation of the outcome prioritization tool).	Using numeric rating scales from 0 to 10 (adaptation of the outcome prioritization tool) to assess patient perceived importance of analgesic effect relative to not having the following side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean the specific outcome is a higher priority for the participant.	Single measure at a time selected by the participant within the study period (up to 15 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analgesic side effect burden measured by numeric rating scales (NRS)	Using numeric rating scales, from 0 to 10, to assess current burden of the following analgesic side effects: fatigue, drowsiness (sleepiness), dizziness, difficulty concentrating, nausea, constipation (difficulty passing stools), dry mouth, unintentional weight gain, addiction (medication craving). Higher scores mean being more affected by the side effects.	Single measure at a time selected by the participant within the study period (up to 15 months).
Patient pain levels in the last 24 hours and pain body location and its impact on functioning measured by the Brief Pain Inventory short form (BPI-SF).		Single measure at a time selected by the participant within the study period (up to 15 months).
Overall pain levels in the past 7 days measured by a numeric rating scale.	Numeric rating scale from 0 to 10, with higher scores meaning higher pain levels.	Single measure at a time selected by the participant within the study period (up to 15 months).
Overall sleep quality in the past 7 days measured by a numeric rating scale.	Numeric rating scale from 0 to 10, with higher scores meaning better sleep.	Single measure at a time selected by the participant within the study period (up to 15 months).
Satisfaction of pain treatment will be assessed by select items from the PTSS	Patient treatment satisfaction will be assessed using 6 selected items from the Pain Treatment Satisfaction Scale (PTSS). The 6 items using 5-point Likert scales assess satisfaction of the time that it takes their pain medication to work, level or amount of pain relief, duration of pain relief, overall satisfaction, and to what extend the level of pain relief meet their expectations.	Single measure at a time selected by the participant within the study period (up to 15 months).
Evaluating Patient characteristics	Patient characteristics including demographics and which pain type/diagnosis and medications and dose are used including alternative/supplementary treatments.	Single measure at a time selected by the participant within the study period (up to 15 months).
MacArthur Scale of Subjective Social Status assessing subjective social status	Single-item measure, on a scale from 1 to 10, that assesses a person's perceived rank relative to others with a higher score meaning a higher rank.	Single measure at a time selected by the participant within the study period (up to 15 months).
Single Item Global Quality of Life Scale (SIG-QoL)	Assessing global quality of life through a Numerical Rating Scale on a scale from 0 to 100 that includes 11 descriptive markers where a higher scores means a better QOL.	Single measure at a time selected by the participant within the study period (up to 15 months).
Patient Health Questionnaire-4 (PHQ-4) is used to measure anxiety and depression	The PHQ-4 uses a 4-point Likert scale (Not at all, Several days, More than half the days, Nearly every day).	Single measure at a time selected by the participant within the study period (up to 15 months).
Current Opioid Misuse Measure - 9 items (COMM-9) is used to identify current aberrant opioid-related behavior in chronic pain patients on long-term opioid therapy	The COMM-9 uses a 5-point Likert scale (Never, Seldom, Sometimes, Often, Very often).	Single measure at a time selected by the participant within the study period (up to 15 months).
PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a assesses patient-perceived cognitive deficits.	The PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a uses a 5-point Likert scale (Never, Rarely (Once), Sometimes (Two or three times), Often (About once a day), Very often (Several times a day)).	Single measure at a time selected by the participant within the study period (up to 15 months).

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 18, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Behavioral Disciplines and Activities; Psychological Tests; Surveys and Questionnaires; Patient Health Questionnaire
• Other Study ID Numbers: QSPainRelief-PatientPref

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No