Chronic PainOpi-PrimNCT06856733
Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care
A study testing Person-centred team-based approach in people with Chronic Pain and Chronic Pain Management, run by Uppsala County Council, Sweden at 4 sites in Sweden.
Trial summary
The goal of this clinical trial is to reduce inappropriate long term opioid treatment (LTOT) and to optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centred and team-based approach. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Chronic Pain Management, Primary Care
- What is being tested?
- Person-centred team-based approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 4 sitesSweden
- Study dates
- 10 Mar 2025to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having received the equivalent of 90 days or more prescription of opioids for chronic pain made by the general practitioner during the recent 12 months
- Able to speak Swedish or English
Who cannot join
- Having been referred to a pain clinic (either at hospital or multimodal rehabilitation in primary care) within the last 6 months
- No current opioid use, severe cognitive dysfunction, e.g., suicidal ideation, psychotic symptoms, or dementia, that prevents informed consent.
- Using their opioids for cancer pain
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden4 sites, 4 recruiting
- Not yet recruiting
Region Gävleborg
Gävle, Gävleborg County
Paul Dranichnikov, MD, PhD, +46762175118, paul.dranichnikov@uu.se
- Recruiting
Region Örebro Län
Örebro, Örebro County
Elsa Ekelin, MD, +46708395260, elsa.ekelin@regionorebrolan.se
- Not yet recruiting
Region Sörmland
Strängnäs, Södermanland County
Johanna Haraldsson, MD, PhD, +46708636813, johanna.haraldsson@uu.se
- Recruiting
Region Uppsala
Uppsala, Uppsala County
Anna Svensson, MD, +46702206400, anna.k.svensson@uu.se
About this study
Official title: Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care (Opi-Prim)
The goal of this clinical trial is to reduce inappropriate long term opioid treatment (LTOT) and to optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centred and team-based approach. The main question it aims to answer is:
What are the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care?
Read more
Researchers will compare a new person-centred and team-based approach to usual care to see if pain interference is lower.
Participants will receive a person-centred team-based treatment consisting of:
- Phase 1 (investigation and assessment, week 1-3): A medication review, pain analysis and other assessments through separate visits to a pharmacist, general practitioner, physiotherapist, psychologist and care manager
- Phase 2 (treatment plan, week 3-4): A team consultations with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made based.
- Phase 3 (treatment and follow-up, week 4-24): Implementation of the individualized rehabilitation plan with frequent follow-up contacts (1 per 1-3 weeks) by phone with the care manager.
Read the detailed description
The evidence for prescribing opioids to patients suffering from chronic non-cancer pain is weak, and using opioids in these circumstances is questionable. Swedish primary health care is responsible for about one-third of all first-time opioid prescriptions and has the highest rate of prescription renewals for opioids. The decision for long-term opioid therapy (LTOT) should rest on an accurate pain analysis and should result in an individualized assessment where the risks of LTOT are set against the impact on quality of life that living with long-term pain entails. Multi-professional interventions and a person-centered approach are recommended for chronic non-cancer pain. Although pharmacists in primary health care have been established internationally with successful examples related to LTOT, their role in Swedish primary care and the management of chronic non-cancer pain remains to be studied. Currently, it is unclear which interventions are effective in reducing inappropriate LTOT and which alternative interventions are suitable for patients who are currently receiving LTOT. The involvement of a care manager in the patient´s care has shown promising results regarding quality of care for other long-term conditions, for example depresssion. In Region Uppsala, clinical pharmacists havte recently been employed in primary health care, but it is unclear what their tasks and responsibilities are and how to best make use of their competence. It is therefore relevant and justified to investigate a new person-centered team-based approach including care manager and pharmacist to optimize the management of pain in patients with chronic non-cancer pain in Swedish primary care. This project aims to reduce inappropriate LTOT and optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centered and team-based approach.
Primary objective:
To investigate the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care
Trial design and setting:
This study is a controlled before-and-after study that has been designed, and will be reported, according to the CONSORT guidelines. Participation will be during 52 weeks (12 months).
This study will be conducted at eight healthcare centres in Region Uppsala. At four of the healthcare centres, a new person-centred team-based treatment model including pharmacists (intervention) will be implemented. Prerequisites for these healthcare centres are the accessibility of at least one person of each healthcare profession: pharmacist, general practitioner (GP), psychologist (or social worker) and physiotherapist, where one of these (or a rehabilitation coordinator or a nurse) takes the role of care manager. Healthcare personnel will receive special training in managing patients with chronic pain before the study. In addition, four control healthcare centres without a pharmacist will be matched with the intervention healthcare centres according to geographic area (urban, suburban, rural), socioeconomical setting and the size of the centres (number of listed patients). No specific efforts of implementation will be made in these control centres.
Prior to the full trial, a feasibility study will be conducted at one intervention centre and one control centre with 12 weeks follow-up per participant.
- Conditions
- Chronic Pain, Chronic Pain Management, Primary Care
- Being tested
- Person-centred team-based approach
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Person-centred team-based approachBehavioural
Phase 1 (investigation and assessment, week 1-3):
- A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist.
- A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms.
- A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities.
- A visit to a psychologist for diagnostics and treatments regarding psychological and social factors.
- A visit to a care manager
Phase 2 (treatment plan, week 3-4):
- A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made.
Phase 3 (treatment and follow-up, week 4-24):
- Implementation of the individualized rehabilitation plan.
- Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager.
- A second team consultation half-way
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants in the control healthcare centres will receive usual care. This may include appointments and treatment by a general practitioner, nurse, physiotherapist and/or psychologist. No pharmacist will be working at the healthcare centre. However, Uppsala County Council does provide centralized medication review services to all primary healthcare centres in Region Uppsala. Any healthcare professional may request a medication review by a pharmacist on a work-from-home basis as part of usual care. |
| Intervention | Active comparator | Phase 1 (investigation and assessment, week 1-3):
* A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist.
* A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms.
* A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities.
* A visit to a psychologist for diagnostics and treatments regarding psychological and social factors.
* A visit to a care manager
Phase 2 (treatment plan, week 3-4):
- A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made.
Phase 3 (treatment and follow-up, week 4-24):
* Implementation of the individualized rehabilitation plan.
* Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager.
* A second team consultation half-way Receives: Behavioral: Person-centred team-based approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain interference
Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse.
Measured: The primary outcome measure will be the difference in mean pain interference after 6 months.
Secondary outcomes (8)
Pain intensity
Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 3-8. Scale: 0-10. Higher score is worse
Measured: After 3, 6 and 12 months
Symptoms of depression
Measured with the Patient Health Questionnaire-9 (PHQ-9). Scale: 0-27. Higher score is worse
Measured: After 3, 6 and 12 months
Symptoms of anxiety
Measured with the General Anxiety disorder-7 (GAD-7). Scale: 0-27. Higher score is worse
Measured: After 3, 6 and 12 months
Patient satisfaction
Measured with the Patients´ Global impression of Change (PGIC). Scale: 0-6. Higher score is worse
Measured: After 3, 6 and 12 months
Quality of life according to the 5-level EuroQol 5D
Measured with the 5-level EuroQol 5D (EQ-5D-5L). Scale: 1-5 per dimension. Higher score is worse.
Measured: After 3, 6 and 12 months
Opioid use
Measured with as morphine equivalents: in mg.
Measured: After 3, 6 and 12 months
Symptoms of withdrawal
Measured with the Short Opioid Withdrawal Scale (SOWS). Scale: 0-40. Higher score is worse
Measured: After 3, 6 and 12 months
Pain interference
Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse.
Measured: After 3 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start10 Mar 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Uppsala University, Örebro University, Sweden, Sormland County Council, Sweden, Örebro County Council
- Responsible party
- Principal investigator, Thomas Kempen, Uppsala County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856733
- Sponsor's protocol ID
- Opi-Prim
- Acronym
- Opi-Prim
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Svensson A, Ljungvall H, Kempen T, Kalvemark-Sporrong S, Peterson M. The constant conflicts of opioid prescribing - GPs' views on treating chronic pain with opioids in primary care: a reflexive qualitative analysis. Scand J Prim Health Care. 2026 Dec;44(1):2665697. doi: 10.1080/02813432.2026.2665697. Epub 2026 May 5.
PubMed 42083502
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care (Opi-Prim)
- ClinicalTrials.gov ID
- NCT06856733
- Acronym / sponsor ID
- Opi-Prim / Opi-Prim
- Conditions
- Chronic Pain, Chronic Pain Management, Primary Care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Uppsala County Council, SwedenOther government
- Collaborators
- Uppsala University, Örebro University, Sweden, Sormland County Council, Sweden, Örebro County Council
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 4 Mar 2025 (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 goal of this clinical trial is to reduce inappropriate long term opioid treatment (LTOT) and to optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centred and team-based approach. The main question it aims to answer is:
What are the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care?
Researchers will compare a new person-centred and team-based approach to usual care to see if pain interference is lower.
Participants will receive a person-centred team-based treatment consisting of:
- Phase 1 (investigation and assessment, week 1-3): A medication review, pain analysis and other assessments through separate visits to a pharmacist, general practitioner, physiotherapist, psychologist and care manager
- Phase 2 (treatment plan, week 3-4): A team consultations with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made based.
- Phase 3 (treatment and follow-up, week 4-24): Implementation of the individualized rehabilitation plan with frequent follow-up contacts (1 per 1-3 weeks) by phone with the care manager.
Detailed description
The evidence for prescribing opioids to patients suffering from chronic non-cancer pain is weak, and using opioids in these circumstances is questionable. Swedish primary health care is responsible for about one-third of all first-time opioid prescriptions and has the highest rate of prescription renewals for opioids. The decision for long-term opioid therapy (LTOT) should rest on an accurate pain analysis and should result in an individualized assessment where the risks of LTOT are set against the impact on quality of life that living with long-term pain entails. Multi-professional interventions and a person-centered approach are recommended for chronic non-cancer pain. Although pharmacists in primary health care have been established internationally with successful examples related to LTOT, their role in Swedish primary care and the management of chronic non-cancer pain remains to be studied. Currently, it is unclear which interventions are effective in reducing inappropriate LTOT and which alternative interventions are suitable for patients who are currently receiving LTOT. The involvement of a care manager in the patient´s care has shown promising results regarding quality of care for other long-term conditions, for example depresssion. In Region Uppsala, clinical pharmacists havte recently been employed in primary health care, but it is unclear what their tasks and responsibilities are and how to best make use of their competence. It is therefore relevant and justified to investigate a new person-centered team-based approach including care manager and pharmacist to optimize the management of pain in patients with chronic non-cancer pain in Swedish primary care. This project aims to reduce inappropriate LTOT and optimize pain management in patients with LTOT for chronic non-cancer pain in primary care through a new person-centered and team-based approach.
Primary objective:
To investigate the effects of a new person-centred and team-based approach on pain interference in patients with LTOT for chronic non-cancer pain in primary care
Trial design and setting:
This study is a controlled before-and-after study that has been designed, and will be reported, according to the CONSORT guidelines. Participation will be during 52 weeks (12 months).
This study will be conducted at eight healthcare centres in Region Uppsala. At four of the healthcare centres, a new person-centred team-based treatment model including pharmacists (intervention) will be implemented. Prerequisites for these healthcare centres are the accessibility of at least one person of each healthcare profession: pharmacist, general practitioner (GP), psychologist (or social worker) and physiotherapist, where one of these (or a rehabilitation coordinator or a nurse) takes the role of care manager. Healthcare personnel will receive special training in managing patients with chronic pain before the study. In addition, four control healthcare centres without a pharmacist will be matched with the intervention healthcare centres according to geographic area (urban, suburban, rural), socioeconomical setting and the size of the centres (number of listed patients). No specific efforts of implementation will be made in these control centres.
Prior to the full trial, a feasibility study will be conducted at one intervention centre and one control centre with 12 weeks follow-up per participant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants in the control healthcare centres will receive usual care. This may include appointments and treatment by a general practitioner, nurse, physiotherapist and/or psychologist. No pharmacist will be working at the healthcare centre. However, Uppsala County Council does provide centralized medication review services to all primary healthcare centres in Region Uppsala. Any healthcare professional may request a medication review by a pharmacist on a work-from-home basis as part of usual care. |
| Intervention | Active comparator | Behavioral: Person-centred team-based approachPhase 1 (investigation and assessment, week 1-3): * A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist. * A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms. * A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities. * A visit to a psychologist for diagnostics and treatments regarding psychological and social factors. * A visit to a care manager Phase 2 (treatment plan, week 3-4): - A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made. Phase 3 (treatment and follow-up, week 4-24): * Implementation of the individualized rehabilitation plan. * Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager. * A second team consultation half-way |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having received the equivalent of 90 days or more prescription of opioids for chronic pain made by the general practitioner during the recent 12 months
- Able to speak Swedish or English
Key exclusion criteria (3 listed)
- Having been referred to a pain clinic (either at hospital or multimodal rehabilitation in primary care) within the last 6 months
- No current opioid use, severe cognitive dysfunction, e.g., suicidal ideation, psychotic symptoms, or dementia, that prevents informed consent.
- Using their opioids for cancer pain
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 |
|---|---|---|
| Person-centred team-based approachPhase 1 (investigation and assessment, week 1-3): * A medication review focusing on pain, sleep and depression/anxiety disorders by a pharmacist. * A thorough pain analysis by a GP according to existing guidelines including duration of pain, pain localization and pain mechanisms. * A visit to a physiotherapist for evaluation and assessment of possible treatment regarding physical exercise/physical activities. * A visit to a psychologist for diagnostics and treatments regarding psychological and social factors. * A visit to a care manager Phase 2 (treatment plan, week 3-4): - A team consultation with all healthcare personnel involved in Phase 1 including the patient where an individualized rehabilitation plan is made. Phase 3 (treatment and follow-up, week 4-24): * Implementation of the individualized rehabilitation plan. * Frequent follow-up contacts (1 per 1-3 weeks) by phone with an established contact person, i.e. care manager. * A second team consultation half-way | Behavioural | Intervention |
Primary outcome
Pain interference
Time frame: The primary outcome measure will be the difference in mean pain interference after 6 months.
Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse.
8 secondary outcomes
Pain intensity
Time frame: After 3, 6 and 12 months
Symptoms of depression
Time frame: After 3, 6 and 12 months
Symptoms of anxiety
Time frame: After 3, 6 and 12 months
Patient satisfaction
Time frame: After 3, 6 and 12 months
Quality of life according to the 5-level EuroQol 5D
Time frame: After 3, 6 and 12 months
Opioid use
Time frame: After 3, 6 and 12 months
Symptoms of withdrawal
Time frame: After 3, 6 and 12 months
Pain interference
Time frame: After 3 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Results publication: PubMed 42083502Svensson A, Ljungvall H, Kempen T, Kalvemark-Sporrong S, Peterson M. The constant conflicts of opioid prescribing - GPs' views on treating chronic pain with opioids in primary care: a reflexive qualitative analysis. Scand J Prim Health Care. 2026 Dec;44(1):2665697. doi: 10.1080/02813432.2026.2665697. Epub 2026 May 5.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Person-centred team-based approach in people with Chronic Pain and Chronic Pain Management, run by Uppsala County Council, Sweden at 4 sites in Sweden.
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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magnus Peterson, PhD, MD (+46702882768, magnus.peterson@regionuppsala.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain interference (time frame: The primary outcome measure will be the difference in mean pain interference after 6 months.). 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 NCT06856733, 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 30 Sep 2026.