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| Name | Class |
|---|---|
| Aleris-Hamlet Hospital | UNKNOWN |
| University of Copenhagen | OTHER |
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Chronic pain is a significant problem for a large part of the adult population. Opioids are the mainstay of therapy for moderate to severe pain because of their safety, multiple routes of administration, reliability, and effectiveness for all types of pain. However, there is a wide variation in treatment response and a high frequency of side effects associated with the use of opioids. Thus it is important to identify patients who will experience successful pain control with treatment. Unfortunately, as of today no robust objective measures exist for the assessment of the pain-relieving effect of opioids. The pain treatment offered to any given patient is thus largely dependent on the treating physician's experience and the primary pain diagnosis, rather than the characteristics of the individual patient. Unfortunately, this strategy often leads to inadequate treatment, side effects and distress. An implementable clinical tool that can predict and distinguish successful pain control with opioid treatment is therefore warranted.
Quantitative sensory testing (QST) is a method to evaluate the individual pain system. It has been successfully used to describe the problems of individual variation in pain and to predict and measure the responses to an intervention. The investigators recently examined how advanced analyses of QST and pain-related catastrophic thinking could predict opioid response in chronic pain patients whom had not previously received opioid treatment. This study showed that the effect of opioid treatment was predicted by certain pain system responses, catastrophic thinking related to pain and brainwave patterns. The investigators now want to expand on this study by including all patients assigned to opioid treatment by their treating physician. The investigators are also increasing their data collection and using a more elaborate pain system characterization, investigating pain-relevant psychological factors and sleep patter by questionnaires, socio-demographic parameters and collecting descriptive genetic information.
The overall goal of the ABILITY-2 study is to help improve pain diagnostics and treatment by developing an implementable algorithm based on individual patient characteristics to be used in the clinic. The investigators hypothesize that successful pain control with opioids can be predicted before treatment initiation with advanced analyses of QST, pain-related psychological factors and socio-demographic data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid Analgesic Treatment | Chronic paint patients receiving opioid treatment at a Multidisciplinary Pain Center following local SOPs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid Analgesic Treatment | Other | Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in chronic pain assessed by 0-10 numerical rating scale (NRS) scores on the Brief Pain Inventory (BPI) | The absolute and percentage change from baseline in ratings of average pain in the past 24h at Day 30. Of note, a percentage change of ≥30% is considered clinically significant. On the NRS, 0 reflects no pain and 10 reflecs worst pain imaginable in this experimental setup. | 30 days |
| Change in health-related quality of life assessed by QLQ-C30 scores | The absolute and percentage change from baseline in ratings of health-related quality of life in the past week at Day 30. A subjectively significant change in QLQ-C30 scores is one that is ≥10 from baseline.The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Impression of Change | Patients impression of change reported as a 7 item assesment of change (1 = much worse and 7 = much better) and the importance of this change (1 = not at all important to 5= extremely important) | 30 days |
| The Brief Pain Inventory (BPI) worst pain in the past 24h assessed by 0-10 numerical rating scale (NRS) scores |
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Inclusion Criteria:
Exclusion Criteria:
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Participants referred tol treatment at a Multidisciplinary Pain Clinic
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asbjørn M Drewes, MD | Contact | 0045 9766 3562 | amd@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Asbjørn M Drewes, MD | Aalborg University Hospital | Study Director |
| Torsten Jonsson, MD | Aleris-Hamlet Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris-Hamlet Hospital | Ringsted | 4100 | Denmark |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Saliva
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Change from baseline. On the NRS, 0 reflects no pain and 10 reflecs worst pain imaginable in this experimental setup. |
| 30 days |
| The Brief Pain Inventory (BPI) least pain in the past 24h assessed by 0-10 numerical rating scale (NRS) scores | Change from baseline, On the NRS, 0 reflects no pain and 10 reflecs worst pain imaginable in this experimental setup. | 30 days |
| The Brief Pain Inventory (BPI) current pain in the past 24h assessed by 0-10 numerical rating scale (NRS) scores | Change from baseline, On the NRS, 0 reflects no pain and 10 reflecs worst pain imaginable in this experimental setup. | 30 days |
| The Brief Pain Inventory (BPI) pain severity in the past 24h assessed by 0-10 numerical rating scale (NRS) scores | Change from baseline, On the NRS, 0 reflects no pain and 10 reflecs worst pain imaginable in this experimental setup. | 30 days |
| Severity of Adverse Events | Total score of Adverse Events rated from 1-4 in severity, with 1 being "not at all" and 4 being "Very much". Following adverse events: Constipation, Dry mouth, Nausea/vomiting, Sedation Sweats Bad dreams, Dysphoria/delirium Sleep disturbances, Fatigue, Absent minded, Concentration difficulties, Depressed, Weight gain, Muscle tension, Urination difficulties Ich/Rash, Other | 30 days |