Pain Reprocessing Therapy for Chronic Widespread Pain: a SCED Study

NCT07050758 | Active Not Recruiting DMC

• 1 other identifier: 2025032
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pain; Chronic widespread pain; Fibromyalgia; Pain reprocessing therapy; SCED; Single-case experimental design

Outcome Measures

Primary Outcomes (3)

• Ecological Momentary Assessment (EMA) questionnaire

  Participants will answer EMA questions 4 times per day (morning, noon/early afternoon, afternoon, and evening) during the baseline period (6-14 days, pseudorandomized) and throughout the intervention period (4-8 weeks). Every questionnaire includes questions about current activity, affect, mood, pain, and social connectedness. The morning questionnaire includes an additional question about sleep quality, and the evening questionnaire includes additional questions about rest, feeling present, medicine use, pain-related worrying, overall pain intensity, perceived ability to manage pain, adjustment of daily activities due to pain, and avoidance of pain throughout the day. Additionaly, each individual answer a personal targeted question (evening only) formulated in collaboration with the patient with at baseline. While most questions are rated using Visual Analog Scale (VAS), some use open text (current activity, medicine), yes/no (current pain), multiple choice (pain location, rest).

  During baseline (6-14 days, pseudorandomized) and throughout the intervention period (4-6 weeks)

• Change from baseline in the Brief Pain Inventory (BPI) - Pain severity

  The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the Brief Pain Inventory (BPI) - Pain interference

  The Brief Pain Inventory is a 17-items questionnaire that assesses pain severity (0-10 Numeric Rating Scale, NRS), pain interference with activities (0-10 NRS), medication used for pain, and a body map in which the participant may mark body areas where pain is present.

  From enrolment to the end of treatment at 4-6 weeks

Secondary Outcomes (14)

• Change from baseline in the Pain Catastrophizing Scale (PCS)

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the Pain Coping Questionnaire - short form

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the State-Trait Anxiety Inventory (State questionnaire only)

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the Generalized Anxiety Disorder Assessment (GAD-7)

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the Becks Depression Inventory II (BDI-2)

  From enrolment to the end of treatment at 4-6 weeks

Other Outcomes (2)

• Change from baseline in the Brief Pain Inventory (BPI) - Medication

  From enrolment to the end of treatment at 4-6 weeks

• Change from baseline in the Brief Pain Inventory (BPI) - Body map

  From enrolment to the end of treatment at 4-6 weeks

Study Arms (1)

Pain Reprocessing Therapy

EXPERIMENTAL

After a baseline period of 6-14 days (pseudorandomized duration), patients will undergo 9 interventional sessions over a span of 4-6 weeks. This includes an initial consultation with a medical doctor in order to confirm that clinical inclusion criteria are met and exclude potential structural (nociceptive or neuropathic) causes of pain. After this consultation, participants undergo 8 PRT sessions with a clinical psychologist trained in PRT.

Behavioral: Pain Reprocessing Therapy

Interventions

Pain Reprocessing Therapy BEHAVIORAL

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.

Pain Reprocessing Therapy

Eligibility Criteria

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

You may qualify if:

• Age 18-65 (inclusive)
• Qualifying for Chronic Widespread Pain (CWP), as described in ICD-11 (an existing diagnosis of fibromyalgia qualifies for CWP)
• Baseline pain with an average intensity of at least 4/10 that has lasted for 3 months or longer
• If on medication that could potentially interfere with study participation or outcomes as evaluated by the study physician, stable doses of medication for 6 weeks prior to entering the study and during participation
• Living in Norway
• Fluent in Norwegian
• Normal or corrected-to-normal vision
• Access to smartphone or equivalent for use of app during study

You may not qualify if:

• Current comorbid acute pain condition (pain from acute illness, injury, infection, or similar in the past 3 weeks)
• Beck Depression Index (BDI) score more than 30
• Clinical high risk for suicidality (BDI short form item 7 on suicidality rated ≥ 2, or modaterate/high scores for suicidality in M.I.N.I. interview)
• Current psychological therapy for pain or mental health purposes
• Any current or past diagnosis and/or significant symptoms of psychosis-related disorders (schizophrenia, schizoaffective disorder), bipolar disorder, autism spectrum disorder, personality disorder
• Current diagnosis and/or significant symptoms of post-traumatic stress disorder (PTSD), eating disorder, substance use disorder, obsessive-compulsive disorder (OCD)
• Currently participating in other therapeutic trials
• Currently in a legal process regarding disability benefits.
• Currently pregnant
• Started an antidepressant or changed dose in the past 6 weeks
• Inability to reliably complete tasks related to the study
• Any impairment, activity or situation that in the judgement of the Study Coordinator or Principal Investigator would prevent satisfactory completion of the study protocol. This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.

Sponsors & Collaborators

• Oslo University Hospital: lead
• Kristiania University College: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 1900, Norway

Location

MeSH Terms

Conditions

Pain; Chronic Pain; Fibromyalgia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Dan-Mikael Ellingsen, PhD

  Oslo University Hospital: Oslo Universitetssykehus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: The investigators will use a randomized multiple baselines Single-case experimental design. This is a within-subjects design commonly used in SCED studies, in which each participant has a baseline period with a randomized duration (i.e. different participants are assessed for a different number of days prior to treatment onset).

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: July 3, 2025
• Study Start: May 7, 2025
• Primary Completion: September 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From publication of the primary results until 5 years after study completion.
• Access Criteria: Anonymized data and analysis code will be shared through publicly available databases such as Open Science Framework.

Locations

NO (1)