Pain Reprocessing Therapy for Chronic Primary Pain

NCT07287072 | Not Yet Recruiting

• 1 other identifier: 884238
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nociplastic Pain; Chronic Primary Pain

Keywords

chronic primary pain; Nociplastic pain; Pain Reprocessing Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Physical function measured through PROMIS-29

  5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session) and at 1 year follow-up

• Individual goals assessed through Goal Attainment Scaling (GAS)

  5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session) and at 1 year follow-up

• Work participation at 1-year follow-up

  Assessed through self-report at 5 weeks follow-up and 1 year follow-up

• Patient Global Impression of Change

  5-week post-treatment assessment (5 weeks after first PRT session; 1 week after final PRT session)

Other Outcomes (3)

• Perceived injustice

  Baseline, 5 weeks and 1 year follow-up

• Pain catastrophizing

  Measured at 5 weeks post-treatment and at 1 year follow-up.

• Fear of movement or re-injury

  Measured 5 weeks post-treatment and at 1 year follow-up.

Study Arms (1)

PRT

EXPERIMENTAL

Pain Reprocessing Therapy

Behavioral: Pain Reprocessing Therapy

Interventions

Pain Reprocessing Therapy BEHAVIORAL

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").

PRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

Ullevål sykehus

Oslo, Norway

Location

Related Publications (1)

• 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.

  PMID: 34586357 BACKGROUND

MeSH Terms

Conditions

Nociplastic Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Silje E Reme, PhD

CONTACT

22845236; siljerem@uio.no

Lars Petter Granan, PhD

CONTACT

23026161

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and psychologist

Model Details: Single Case Experimental Design (SCED). In a SCED study, the unit of analysis is the individual rather than the group, and the patient serves as their own control. Participants will be randomized to different starting periods for the intervention (Phase B) as soon as they are included in the study.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: From end of assessment (July 31st) and until December 31st 2027).
• 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.

Locations

NO (1)