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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRT | Experimental | Pain Reprocessing Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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"). |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ullevål sykehus | Oslo | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34586357 | Background | 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. |
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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.
From end of assessment (July 31st) and until December 31st 2027).
Access will be restricted to qualified researchers who submit an application and obtain approval from the relevant ethics committee and data protection authority.
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| ID | Term |
|---|---|
| D000098653 | Nociplastic Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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| 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 |
| 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) |
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. |