Back to resultsPOINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain (POINT)
Primary Purpose
Chronic Pain, Opioid Use
Status
Recruiting
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
POINT1
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria: non-malignant, chronic pain Registered in Stavanger municipality Consent to participation. Age 18 - 67 years Pain duration <10 years Exclusion Criteria: malignant pain condition
Sites / Locations
- Stavanger municipalityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Point1
Arm Description
Receiving treatment
Outcomes
Primary Outcome Measures
Change From Baseline in Audit C at 12 Weeks
Audit C
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks
Visual Analog Scale
Change from baseline in Bergen Insomnia scale at 12 Weeks
BIS
Change from baseline in Health-related quality of life at 12 Weeks
HQ5D5L
Secondary Outcome Measures
Full Information
NCT ID
NCT05828121
First Posted
February 8, 2023
Last Updated
April 12, 2023
Sponsor
Helse Stavanger HF
Collaborators
The Research Council of Norway
1. Study Identification
Unique Protocol Identification Number
NCT05828121
Brief Title
POINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
Acronym
POINT
Official Title
Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helse Stavanger HF
Collaborators
The Research Council of Norway
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators do research on chronic pain treatment to minimize the risks associated with opioids.
Detailed Description
The investigators know that patients suffering from chronic pain need good treatment. The use of opioids for chronic, non-cancer related pain may seem appropriate in the short term, but can often have negative consequences for both the individual and society in the long term.
Several factors-the escalating use of opioids to chronic pain patients, the increasing use of strong opioids in particular, and the increasing number of overdoses caused by prescription opioids-point to the start of an opioid epidemic in Norway.
Objectives The overall goal of the POINT project is to provide knowledge to optimize treatment of patients with chronic pain in order to avoid unnecessary escalation of opioid treatment, improve their quality of life and reduce the burden of disease.
In the long run our objective is to prevent the unwanted consequences of opioid treatment and improve patients' quality of life.
Ultimately, through this project the investigators hope to prevent an opioid epidemic in Norway.
To achieve the main goal, the investigators will focus on pain patients and their doctors, as increasing opioid use may occur through the patient-doctor interaction.
Methods
The project will develop and test a non-drug interventions that consist of an interdisciplinary group treatment .
Financing The Research Council of Norway
Cooperation St. Olavs Hospital
Stavanger Hospital Trust
City of Stavanger
National Institute of Public Health (FHI)
Alcohol and Drug Research Western Norway (KoRFor)
Foreningen for kroniske smertepasienter (FKS) Norwegian Forum of Disabled Peoples' Organizations (SAFO)
Cooperation with other projects Injury Prevention and Outcomes following Trauma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Opioid Use
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
MRC framework for a complex intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Point1
Arm Type
Experimental
Arm Description
Receiving treatment
Intervention Type
Behavioral
Intervention Name(s)
POINT1
Intervention Description
Receiving treatment
Primary Outcome Measure Information:
Title
Change From Baseline in Audit C at 12 Weeks
Description
Audit C
Time Frame
12 weeks
Title
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks
Description
Visual Analog Scale
Time Frame
12 weeks
Title
Change from baseline in Bergen Insomnia scale at 12 Weeks
Description
BIS
Time Frame
12 weeks
Title
Change from baseline in Health-related quality of life at 12 Weeks
Description
HQ5D5L
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-malignant, chronic pain
Registered in Stavanger municipality
Consent to participation.
Age 18 - 67 years
Pain duration <10 years
Exclusion Criteria:
malignant pain condition
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kine Gjesdal, PhD
Phone
004748136702
Email
kine.gjesdal@sus.no
Facility Information:
Facility Name
Stavanger municipality
City
Stavanger
ZIP/Postal Code
4010
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
kine gjesdal, phd
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
2023
Learn more about this trial
POINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
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