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NCT Number: NCT07453524

Assessing Chronic Pain Patient Preferences

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient questionnaire

Other

Online patient questionnaire that assesses multiple aspects such as current analgesic use, side effect burden, treatment satisfaction and patient preferences.

Primary outcomes

  1. 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).

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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.

Secondary outcomes

  1. Analgesic side effect burden measured by numeric rating scales (NRS)

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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.

  2. 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).

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

  3. Overall pain levels in the past 7 days measured by a numeric rating scale.

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    Numeric rating scale from 0 to 10, with higher scores meaning higher pain levels.

  4. Overall sleep quality in the past 7 days measured by a numeric rating scale.

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    Numeric rating scale from 0 to 10, with higher scores meaning better sleep.

  5. Satisfaction of pain treatment will be assessed by select items from the PTSS

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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.

  6. Evaluating Patient characteristics

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    Patient characteristics including demographics and which pain type/diagnosis and medications and dose are used including alternative/supplementary treatments.

  7. MacArthur Scale of Subjective Social Status assessing subjective social status

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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.

  8. Single Item Global Quality of Life Scale (SIG-QoL)

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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.

  9. Patient Health Questionnaire-4 (PHQ-4) is used to measure anxiety and depression

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    The PHQ-4 uses a 4-point Likert scale (Not at all, Several days, More than half the days, Nearly every day).

  10. 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

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    The COMM-9 uses a 5-point Likert scale (Never, Seldom, Sometimes, Often, Very often).

  11. PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a assesses patient-perceived cognitive deficits.

    Time frame: Single measure at a time selected by the participant within the study period (up to 15 months).

    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)).

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: patientPREF

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 6, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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