Pain Reprocessing Therapy for Chronic Primary Pain (PRIME-PRT)

Pain Reprocessing Therapy for Chronic Primary Pain Caused by a Likely Nociplastic Pain Mechanism in Primary Care: The PRIME-PRT Trial

Approximately 30% of adult Norwegians experience chronic pain, with its prevalence rising across demographics, including children and adolescents Chronic pain contributes to significant personal suffering and substantial societal costs. Traditional treatments - physical, pharmacological, and surgical - as well as psychological interventions, such as cognitive and acceptance-based therapies, demonstrate only minor to modest effects.

To address the challenge of rising demand alongside limited treatment options, university hospitals must consistently evaluate and adopt new, potentially effective therapies to meet their societal mission. Pain Reprocessing Therapy (PRT) is one such innovative treatment that has recently demonstrated promising results for a subset of chronic pain patients in a U.S. primary care setting.

In this study, the investigators want to assess the effectiveness of PRT on various outcomes in patients with primary chronic pain that has a likely nociplastic pain mechanism, within a Norwegian primary care population.

The insights from this study will be important for any prospective implementation of PRT to align with one of the guiding principles of the Norwegian healthcare system: the Best Effective Level of Care (BEON principle). The BEON principle supports the delivery of high-quality, cost-effective healthcare services and is founded on the notion of seamless integration across different levels of care. When competence or resources at the primary healthcare level are insufficient, more patients tend to be referred to higher, specialized, and inherently more costly levels of care, such as secondary and tertiary care. Therefore, if the study can demonstrate that PRT is effective within a Norwegian primary care population, the hypothesize is that its implementation could strengthen both primary and tertiary care in alignment with the BEON principle.

Study Overview

• Status: Active, not recruiting
• Conditions: Nociplastic Pain; Chronic Primary Pain
• Intervention / Treatment: Behavioral: Pain Reprocessing Therapy

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Ullevål sykehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 18 and 70
• On sick leave, or at risk of sick leave
• Pain intensity corresponding to 3 (or more) on the NRS from the PROMIS-29.
• Readiness to change, corresponding to the action stage from the readiness to change model, where they are ready to participate in their own change process

Exclusion Criteria:

• Structural causes for their pain (rheumatoid arthritis, cancer, etc.),
• Severe psychiatric conditions (ongoing or previous psychotic disorders, suicidality, or severe depression/anxiety/bipolar disorder)
• Illegal substance abuse, or known dependence on benzodiazepines or opioids
• Ongoing litigation or compensation process related to the pain condition
• Ongoing and severe psychosocial stressors (e.g. recent divorce etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: PRT; Pain Reprocessing Therapy

Behavioral: Pain Reprocessing Therapy; Pain Reprocessing Therapy (PRT) has shown promising results for patients with chronic primary back pain with a nociplastic pain-mechanism. PRT consists of two components. The first is an educational component (E) conducted by a physician. The purpose of the educational component is to reorient the patient's understanding of pain in accordance with the theories of nociplastic pain (false alarm based on negative expectations). The second part consists of a set of specific therapeutic techniques (T) that can be performed by a physician, psychologist, or other trained healthcare personnel. The techniques are easy to learn and have a training framework of 50 hours over a period of 3 months. They are based, among other things, on interoceptive exposure techniques, where the main point is to confront internal sensory experiences that have been interpreted as threatening (and ultimately lead to pain), with a new assurance that they do not signal danger ("false alarm").

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average pain rating in the past 7 days on a numerical rating scale from 0-10 from Patient-Reported Outcomes Measurement Information System - 29 items (PROMIS-29)	Pain intensity average last week assessed through one item. The scale ranges from 0 (no pain) to 10 (worst imaginable pain)	5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work participation at 1-year follow-up	Increased work participation since baseline (y/n)	Assessed through self-report at 5 weeks follow-up and 1 year follow-up
Patient Global Impression of Change	Patients' global impression of change in symptoms, function and quality of life (Hurst, 2004). The scale ranges from 1 (no change) to 7 (a great deal better and considerable improvement)	5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)
Physical function measured through PROMIS-29	Patient-Reported Outcome Measurement Information System (PROMIS-29) average score post-treatment on the domain Physical function. Scores range from 4-20, with higher scores indicating better function	5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 monts and at 1 year follow-up
Individual goals assessed through Goal Attainment Scaling (GAS)	Individual goals as defined by the patient. For instance: "Running up a hill" or "playing basketball" (Ref to GAS: Ruble et al., 2012).	5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session), 3 months and at 1 year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived injustice	Perceived injustice measured by Injustice Experience Questionnaire. The total score ranges from 0-48, with higher score indicating more perceived injustice.	Baseline, 5 weeks and 1 year follow-up
Pain catastrophizing	Pain Catastrophizing Scale measured at 5 weeks post-treatment and at 1 year follow-up. The total score ranges from 0-52, where a higher score indicates more catastrophizing.	Measured at 5 weeks post-treatment and at 1 year follow-up.
Fear of movement or re-injury	Tampa Scale of Kinesiophobia (TSK-11). Scores range from 11 to 44, with higher score indicating more severe fear of movement.	Measured 5 weeks post-treatment and at 1 year follow-up.

Collaborators and Investigators

• Sponsor: University of Oslo

Publications and helpful links

General Publications

• Ashar YK, Gordon A, Schubiner H, Uipi C, Knight K, Anderson Z, Carlisle J, Polisky L, Geuter S, Flood TF, Kragel PA, Dimidjian S, Lumley MA, Wager TD. Effect of Pain Reprocessing Therapy vs Placebo and Usual Care for Patients With Chronic Back Pain: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):13-23. doi: 10.1001/jamapsychiatry.2021.2669.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nociplastic pain; Pain Reprocessing Therapy; chronic primary pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Nociplastic Pain
• Other Study ID Numbers: 884238

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators pan to share de-identified individual participant data with collaborating research groups in Sweden and the Netherlands. Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority. There is also a plan to share the study protocol, statistical analysis plan, and analysis code.
• IPD Sharing Time Frame: From end of assessment (July 31st) and until December 31st 2027).
• IPD Sharing Access Criteria: Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No