NCT07331766

Brief Summary

In this multicenter randomized controlled trial, the aim is to evaluate the effectiveness of a standardized treatment pathway (STP) for patients referred to four participating pain clinics, by comparing it to treatment as usual (TAU) which is standard care at the clinics. The STP differs from TAU in two key aspects:

  • Structured cross-sector collaboration: Involvement of primary healthcare providers, particularly the patient's GP, in two digital collaborative meetings with the pain clinic.
  • Time-bound treatment pathway: A clearly defined treatment trajectory with follow-up over a six-month period. The study aims to answer whether the STP give larger improvements than TAU in the following outcomes:
  • patients´ reported overall impression of change in health (primary outcome)
  • pain interference (primary outcome)
  • physical function and mental health
  • satisfaction with and experience of continuity and integration of the health care services All study participants will follow an initial care pathway at the pain clinic, which includes:
  • a screening consultation with a study coordinator
  • a multidisciplinary clinical assessment based on a biopsychosocial approach by at least to health care professions. The specific professional groups included in each assessment are determined individually based on patient needs. The control group: This group will receive standard care at the pain clinic. This will vary somewhat between the four pain clinics , but almost all patients will be offered a summary consultation with the pain clinic team where further plans for follow-up will be discussed. Some patients will be offered further treatment at the pain clinic. All clinics will send a clinical summary to the referring physician with suggestions for further follow-up. If further collaboration with primary care is needed, it may preferably be written or arranged via telephone. Digital collaborative meeting will not be offered to this group. The intervention group: All patients in this group will be offered the STP with two digital collaborative meetings as described above.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
32mo left

Started Dec 2025

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

4 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress13%
Dec 2025Dec 2028

Study Start

First participant enrolled

December 19, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

January 12, 2026

Status Verified

December 1, 2025

Enrollment Period

3 years

First QC Date

December 29, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

chronic painmultidisciplinary pain clinicStandardized treatment pathwaycollaboration across levels of health carecollaboration

Outcome Measures

Primary Outcomes (2)

  • Pain interference

    Pain interference questions (q8-q14)from the Brief Pain Inventory questionnaire (BPI)

    At baseline and through to 18 months after baseline

  • Overall impression of change in health

    Patient global impression of change questionnaire (PGIC)

    Measured 18 months after baseline

Secondary Outcomes (13)

  • Physical function

    From baseline and to 18 months after baseline

  • Mental health

    From baseline to 18 months after baseline

  • Patient experience of continuity and integration of health care services

    From baseline to 18 months after baseline

  • Trust in health care services and social security services

    From baseline to 18 months after baseline

  • Collaboration between health care services

    From baseline to 18 months after baseline

  • +8 more secondary outcomes

Other Outcomes (3)

  • The referring GP's satisfaction with the pain clinic management

    From within 2 weeks after summary consultation (control group)/ collaborative consultation (intervention group) to 12 months after baseline

  • Pain locations

    From baseline to 18 months after baseline

  • Severity of symptoms of fatigue, depression, memory/concentration, sleep problems, headache and stomach pain

    From baseline to 18 months after baseline

Study Arms (2)

A collaborative treatment pathway for patients referred to multidisciplinary pain clinics.

EXPERIMENTAL

The study intervention is a new standardized treatment pathway with exteded collaboration for patients referred to pain clinics.

Other: A collaborative treatment pathway for patients referred to multidisciplinary pain clinics in Norway

Treatment as usual: Standard care at a multidisciplinary pain clinic

ACTIVE COMPARATOR

Standard care following present procedures at the multidisciplinary pain clinics involved in this study

Other: Treatment as usual

Interventions

The comparator intervention reflects the current standard of care provided at four Norwegian pain clinics. Standard care may vary slightly between clinics but generally includes a multidisciplinary clinical evaluation involving at least two different healthcare professions. A clinical summary outlining recommendations for further follow-up is sent to the referring physician. Most patients also receive a summary consultation with the pain clinic team, and some are offered additional treatment at the pain clinic.

Treatment as usual: Standard care at a multidisciplinary pain clinic

The study intervention is a standardized treatment pathway for patients referred to multidisciplinary pain clinics. The pathway is designed to support structured collaboration across health care levels and other sectors. It includes two digital multidisciplinary meetings with the patient, the pain clinic, and additional stakeholders, such as social security representatives. The pathway delineates a clearly defined course of treatment with scheduled follow-up over a six-month period.

A collaborative treatment pathway for patients referred to multidisciplinary pain clinics.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older who have been granted the right to specialist health care in accordance with the Norwegian National prioritization guideline for pain clinics, and who are scheduled for multidisciplinary treatment involving at least two professionals from the pain clinic.

You may not qualify if:

  • Patients scheduled for monodisciplinary treatment. Patients referred solely for invasive procedures. Patients without sufficient language skills to understand the study information and provide informed consent. Patients are excluded if interpreter services are required.
  • Patients deemed unable to complete study-related tasks (e.g., questionnaires). Patients referred exclusively for stabilization or tapering of opioids or other medications considered addictive.
  • Patients who will be unable to participate in collaborative meetings or follow the treatment plan due to extensive ongoing or planned care trajectories within other specialist health services.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Innlandet Hospital

Ottestad, Innlandet, 2312, Norway

Location

University Hospital of Northern Norway

Tromsø, Troms, 9016, Norway

Location

St Olavs hospital

Trondheim, Trøndelag, 7030, Norway

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Links

MeSH Terms

Conditions

Chronic PainBronchiolitis Obliterans SyndromeMusculoskeletal Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System DiseasesMuscular DiseasesMusculoskeletal Diseases

Study Officials

  • Astrid Woodhouse, Phd

    St Olavs Hospital/ Smertesenteret

    PRINCIPAL INVESTIGATOR
  • Mari Glette, PhD

    St. Olavs Hospital

    STUDY CHAIR
  • Tormod Landmark, PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 29, 2025

First Posted

January 12, 2026

Study Start

December 19, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

January 12, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared because the approved informed consent does not permit data sharing beyond the study team, and applicable data protection regulations (including GDPR) restrict secondary transfer of participant-level health data without explicit consent.

Locations