Identification of Predictive Markers of the Effects of Opioid Therapy in Patients With Chronic Pain. (ABILITY-2)

A Single-site, Observational Cohort Study to Investigate Predictive Markers of the Effects of Opioid Therapy in Patients With Chronic Pain

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Pain
• Intervention / Treatment: Other: Opioid Analgesic Treatment

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Asbjørn M Drewes, MD; Phone Number: 0045 9766 3562; Email: amd@rn.dk

Study Locations

• Denmark
  • Ringsted, Denmark, 4100
    • Aleris-Hamlet Hospital
    • Contact: Torsten Jonsson, MD
    • Principal Investigator: Torsten Jonsson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants referred tol treatment at a Multidisciplinary Pain Clinic

Description

Inclusion Criteria:

1. Pain duration ≥ 3 months.
2. Minimum baseline pain intensity ≥ 4 on a 0-10 numerical rating scale (over the past week).
3. Maximum baseline pain intensity < 9 on a 0-10 numerical rating scale (over the past week).
4. Prescribed opioid treatment (ATC: N02)
5. Anticipated to stay on prescribed opioid treatment throughout the study, i.e. >30 days.
6. Anticipated to stay on any concomitant non-opioid treatment throughout the study, i.e. >30 days.
7. Subject may be male or female, age >18 years old.
8. Is willing and able to comply with study procedures as judged by the site investigator.
9. Subject has voluntarily signed and dated the study-specific informed consent form, approved by an Independent Ethics Committee, after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent form must be signed before any study-specific procedures are performed.

Exclusion Criteria:

1. Has a mental incapacity or language barriers precluding adequate understanding of study procedures.
2. Is considered by the site investigator unsuitable to participate in the study for any other reason, for instance due to a significant serious underlying condition.
3. Current alcohol or substance abuse, according to the site investigator's medical judgement.
4. Are suffering from decreased liver function, kidney function, uncontrolled hypertension or currently in treatment with monoamine oxidate (MAO)-inhibitors
5. Is anticipated to undergo a painful procedure(s) (e.g. surgery) during the study, which can interfere with the experience of the chronic pain condition for which the subject is to receive opioids.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opioid Analgesic Treatment; Chronic paint patients receiving opioid treatment at a Multidisciplinary Pain Center following local SOPs	Other: Opioid Analgesic Treatment; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Asbjørn Mohr Drewes
• Collaborators: University of Copenhagen; Aleris-Hamlet Hospital
• Investigators: Study Director: Asbjørn M Drewes, MD, Aalborg University Hospital; Principal Investigator: Torsten Jonsson, MD, Aleris-Hamlet Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2018
• Primary Completion (ANTICIPATED): March 1, 2020
• Study Completion (ANTICIPATED): March 1, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (ACTUAL): October 10, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 10, 2018
• Last Update Submitted That Met QC Criteria: October 9, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Narcotics; Analgesics, Opioid; Analgesics
• Other Study ID Numbers: ABILITY-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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