Pain Reprocessing Therapy for Chronic Primary Pain

NCT ID: NCT07287072

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nociplastic Pain Chronic Primary Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

chronic primary pain Nociplastic pain Pain Reprocessing Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PRT

Pain Reprocessing Therapy

Group Type EXPERIMENTAL

Pain Reprocessing Therapy

Intervention Type 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").

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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").

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Silje Endresen Reme

Professor and psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UllevÄl sykehus

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Silje E Reme, PhD

Role: CONTACT

Phone: 22845236

Email: [email protected]

Lars Petter Granan, PhD

Role: CONTACT

Phone: 23026161

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 34586357 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

884238

Identifier Type: -

Identifier Source: org_study_id