Chronic Pain
Conditions
Brief summary
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.
Interventions
Online patient questionnaire that assesses multiple aspects such as current analgesic use, side effect burden, treatment satisfaction and patient preferences.
Sponsors
Université Catholique de Louvain
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| Analgesic side effect burden measured by numeric rating scales (NRS) | 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. |
| 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. | 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. |
| Overall sleep quality in the past 7 days measured by a numeric rating scale. | 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. |
| Satisfaction of pain treatment will be assessed by select items from the PTSS | 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. |
| Evaluating Patient characteristics | 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. |
| MacArthur Scale of Subjective Social Status assessing subjective social status | 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. |
| Single Item Global Quality of Life Scale (SIG-QoL) | 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. |
| Patient Health Questionnaire-4 (PHQ-4) is used to measure anxiety and depression | 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). |
| 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 | 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). |
| PROMIS Item Bank v2.0 - Cognitive Function- Short Form 4a assesses patient-perceived cognitive deficits. | 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)). |
Outcome results
None listed