Collaboratory Treatment Pathway for Chronic Pain Patients.
PainPath
Effectiveness of a Novel Cross Sectorial Collaborative Treatment Pathway for Chronic Pain Patients. A Multicenter Randomized Controlled Trial.
2 other identifiers
interventional
386
1 country
4
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Dec 2025
Longer than P75 for not_applicable chronic-pain
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2025
CompletedFirst Submitted
Initial submission to the registry
December 29, 2025
CompletedFirst Posted
Study publicly available on registry
January 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
January 12, 2026
December 1, 2025
3 years
December 29, 2025
December 29, 2025
Conditions
Keywords
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.
EXPERIMENTALThe study intervention is a new standardized treatment pathway with exteded collaboration for patients referred to pain clinics.
Treatment as usual: Standard care at a multidisciplinary pain clinic
ACTIVE COMPARATORStandard care following present procedures at the multidisciplinary pain clinics involved in this study
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.
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.
Eligibility Criteria
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
- Haukeland University Hospitalcollaborator
- University Hospital of North Norwaycollaborator
- St. Olavs Hospitallead
- Sykehuset Innlandet HFcollaborator
Study Sites (4)
Innlandet Hospital
Ottestad, Innlandet, 2312, Norway
University Hospital of Northern Norway
Tromsø, Troms, 9016, Norway
St Olavs hospital
Trondheim, Trøndelag, 7030, Norway
Haukeland University Hospital
Bergen, 5021, Norway
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Astrid Woodhouse, Phd
St Olavs Hospital/ Smertesenteret
- STUDY CHAIR
Mari Glette, PhD
St. Olavs Hospital
- STUDY CHAIR
Tormod Landmark, PhD
St. Olavs Hospital
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.