Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06856733

Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Region Sörmland, Strängnäs, Sörmland, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Person-centred team-based approach

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pain intensity

    Time frame: After 3, 6 and 12 months

    Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 3-8. Scale: 0-10. Higher score is worse

  2. Symptoms of depression

    Time frame: After 3, 6 and 12 months

    Measured with the Patient Health Questionnaire-9 (PHQ-9). Scale: 0-27. Higher score is worse

  3. Symptoms of anxiety

    Time frame: After 3, 6 and 12 months

    Measured with the General Anxiety disorder-7 (GAD-7). Scale: 0-27. Higher score is worse

  4. Patient satisfaction

    Time frame: After 3, 6 and 12 months

    Measured with the Patients´ Global impression of Change (PGIC). Scale: 0-6. Higher score is worse

  5. Quality of life according to the 5-level EuroQol 5D

    Time frame: After 3, 6 and 12 months

    Measured with the 5-level EuroQol 5D (EQ-5D-5L). Scale: 1-5 per dimension. Higher score is worse.

  6. Opioid use

    Time frame: After 3, 6 and 12 months

    Measured with as morphine equivalents: in mg.

  7. Symptoms of withdrawal

    Time frame: After 3, 6 and 12 months

    Measured with the Short Opioid Withdrawal Scale (SOWS). Scale: 0-40. Higher score is worse

  8. Pain interference

    Time frame: After 3 and 12 months

    Measured with the Brief Pain Inventory - Short Form (BPI-SF), question number 9 a-g. Scale: 0-10. Higher score is worse.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Svensson, MD

CONTACT

[email protected]

+46702206400

Magnus Peterson, PhD, MD

CONTACT

[email protected]

+46702882768

Sponsors and collaborators

Lead sponsor

Uppsala County Council, Sweden

Other Gov

Collaborators

  • Sormland County Council, Sweden
  • Uppsala University
  • Örebro County Council
  • Örebro University, Sweden

Registry information

Official study title

Improved Treatment for Patients With Long-term Opioid Therapy for Non-cancer Pain in Primary Care (Opi-Prim)

Acronym: Opi-Prim

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 4, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.