NCT07050758

Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

Pain Reprocessing Therapy for Chronic Widespread Pain - A Randomized Multiple-baseline SCED Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Oslo University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Chronic Widespread Pain (CWP) is classified as a Chronic Primary Pain syndrome in the ICD-11 and is considered a major type of nociplastic pain with an estimated prevalence of up to 8-10% in the general population. Many CWP patients experience inadequate treatment and poor symptom management, leaving them prone to disability. Pain Reprocessing Therapy (PRT) is a novel therapy specifically designed to target nociplastic pain with a combination of cognitive, exposure-based, and interoceptively-focused psychotherapy techniques. A recent clinical trial indicated large effects of PRT for chronic back pain, but no studies have yet investigated PRT for CWP. Furthermore, there is little knowledge about how pain and other outcomes change during PRT intervention (between baseline and post-intervention timepoints). The investigators will use a Single-Case Experimental Design (SCED) to investigate PRT for CWP. Primary outcomes include pain collected at the baseline visit and the post-intervention visit, and Ecological Momentary Assessment (EMA) outcomes including pain, mood, sleep, behavior, and medication, collected up to 4 times per day during the baseline and PRT (intervention) period. Secondary outcomes include a range of state-based outcomes collected at the baseline visit and the post-intervention visit.

Conditions

• Pain
• Chronic Widespread Pain
• Chronic Pain
• Fibromyalgia

Interventions

Type	Name	Description
BEHAVIORAL	Pain Reprocessing Therapy	Each PRT session will take 45-60 minutes and includes psychoeducation about the association between pain and the brain, mindfulness, and exposure- and acceptance-based concepts. Through PRT, participants will learn about how pain can emerge from 'stuck patterns' in neural circuits in the brain. Through reflections of their own pain experiences, the patient explores evidence for whether this applies to their own pain. Patients will acquire corrective experiences in which their brain "learns" not to respond with pain ("false alarm") in situations that are safe. One central reprocessing exercise is 'somatic tracking', in which participants explore their pain sensations in a context of safety. This includes interoceptive exposures and situational exposures to activities they fear will trigger pain. Exploring these sensations and situations through a lens of safety and curiosity allows the participants to reinterpret bodily sensations previously associated with threat or pain, as safe.

Timeline

• Start date: 2025-05-07
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2025-07-03
• Last updated: 2025-09-10

Locations

1 site across 1 country: Norway