Chronic PainPOINTNCT05828121
POINT - Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
A study testing POINT1 in people with Chronic Pain and Opioid Use, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The investigators do research on chronic pain treatment to minimize the risks associated with opioids. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Chronic Pain, Opioid Use
- What is being tested?
- POINT1
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2022to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non-malignant, chronic pain
- Registered in Stavanger municipality
- Consent to participation.
- Age 18 - 67 years
- Pain duration <10 years
Who cannot join
- malignant pain condition
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Stavanger municipality
Stavanger, 4010
kine gjesdal, phd
About this study
Official title: Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
The investigators do research on chronic pain treatment to minimize the risks associated with opioids.
Read the 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
- Conditions
- Chronic Pain, Opioid Use
- Being tested
- POINT1
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POINT1Behavioural
Receiving treatment
| Study group | Role | What they receive |
|---|---|---|
| Point1 | Experimental | Receiving treatment Receives: Behavioral: POINT1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Audit C at 12 Weeks
Audit C
Measured: 12 weeks
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks
Visual Analog Scale
Measured: 12 weeks
Change from baseline in Bergen Insomnia scale at 12 Weeks
BIS
Measured: 12 weeks
Change from baseline in Health-related quality of life at 12 Weeks
HQ5D5L
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Oct 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- MRC framework for a complex intervention
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- The Research Council of Norway
- Responsible party
- Principal investigator, Kine Gjesdal, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828121
- Sponsor's protocol ID
- POINTstavanger
- Acronym
- POINT
- Status last verified
- Apr 2023
- First submitted
- 8 Feb 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gjesdal K, Skurtveit S, Djuv A, Paulsen A, Rolova G, Sevild C, Lid TG. Changes in health literacy following participation in a multidisciplinary primary care intervention for people with chronic pain: a longitudinal cohort study. Scand J Pain. 2026 Oct 6;26(1). doi: 10.1515/sjpain-2026-0034. eCollection 2026 Jan 1.
PubMed 42836695
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing an Opioid Epidemic in Norway: Focusing on Treatment of Chronic Pain
- ClinicalTrials.gov ID
- NCT05828121
- Acronym / sponsor ID
- POINT / POINTstavanger
- Conditions
- Chronic Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- The Research Council of Norway
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MRC framework for a complex intervention
| Arm | Type | Receives |
|---|---|---|
| Point1 | Experimental | Behavioral: POINT1Receiving treatment |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- non-malignant, chronic pain
- Registered in Stavanger municipality
- Consent to participation.
- Age 18 - 67 years
- Pain duration <10 years
Key exclusion criteria (1 listed)
- malignant pain condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POINT1Receiving treatment | Behavioural | Point1 |
Primary outcome
Change From Baseline in Audit C at 12 Weeks
Time frame: 12 weeks
Audit C
Change from baseline in Pain Scores on the Visual Analog Scale at 12 Weeks
Time frame: 12 weeks
Visual Analog Scale
Change from baseline in Bergen Insomnia scale at 12 Weeks
Time frame: 12 weeks
BIS
Change from baseline in Health-related quality of life at 12 Weeks
Time frame: 12 weeks
HQ5D5L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 42836695Gjesdal K, Skurtveit S, Djuv A, Paulsen A, Rolova G, Sevild C, Lid TG. Changes in health literacy following participation in a multidisciplinary primary care intervention for people with chronic pain: a longitudinal cohort study. Scand J Pain. 2026 Oct 6;26(1). doi: 10.1515/sjpain-2026-0034. eCollection 2026 Jan 1.
- Individual participant dataSharing planned: Yes
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POINT1 in people with Chronic Pain and Opioid Use, run by Helse Stavanger HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kine Gjesdal, PhD (004748136702, kine.gjesdal@sus.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Audit C at 12 Weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05828121, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.