Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07791355

Pain Reprocessing Therapy (PRT) in a Specialist Pain Clinic: A Feasibility Study

Long-term pain, which is pain that lasts for more than three months, is a major health problem. It can severely impact a person's physical and mental well-being, quality of life, and ability to work. It also carries high costs for society, mainly due to high rates of sick leave.

For many people with long-term pain, there is no clear injury or disease that fully explains why it hurts. In these cases, the pain is believed to be caused by how the brain and nervous system process pain signals. This is sometimes called "nociplastic pain."

Even though there are many treatments for pain-like medications and therapies-they don't work for everyone, and many people are left without meaningful relief. Because of this, it is important to find and test new ways to treat pain. In this study, the investigators evaluate a relatively new psychological treatment called Pain Reprocessing Therapy (PRT), which has been tested in the US with promising results.

PRT helps individuals with chronic pain to understand and change how they think about their pain by explaining how the brain works. The treatment focuses on teaching the difference between acute (new) pain and long-term pain. It also involves exercises to help people alter emotions related to their pain. A key part of the treatment is a technique where patients practice paying attention to what is happening in their bodies in a safe, relaxed way. The goal is to teach the brain that the pain signals are not a threat. This can help break the vicious cycle of fear, avoiding activities, and worsening pain.

While many people are interested in treatments like PRT, it hasn't yet been tested in specialized care for patients with complex pain. This trial is a pilot study-a smaller, initial investigation to evaluate how well the treatment works in a clinical setting, and to determine if both patients and therapists find it acceptable and practical to use. This will give us important information to help prepare for larger studies in the future.

The main goal of this pilot study is to see if PRT is a practical and accepted treatment in a Swedish pain rehabilitation setting. The investigators also want to look at whether the treatment helps reduce pain, psychological distress, negative thoughts about pain, and the fear of moving. Finally, the investigators will explore how a patient's expectations and thinking skills (such as memory and focus) might affect how well the treatment works, and take physical measurements before and after the treatment to see if the nervous system becomes better at regulating pain.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The overall aim of this project is to conduct a pilot study investigating the feasibility, patient satisfaction, and acceptability of a recently developed psychological treatment for pain: Pain Reprocessing Therapy (PRT). The study will be conducted within a clinical pain rehabilitation setting, where patients frequently present with severe pain, psychiatric comorbidity, and reduced or absent work capacity.

Within the framework of this project, the investigators will evaluate whether PRT can be effectively implemented in a pain rehabilitation context and whether the treatment is perceived as acceptable and feasible by both patients and clinicians. Furthermore, the investigators intend to conduct exploratory analyses to determine if specific clinical subgroups appear more responsive to the intervention.

A secondary aim is to evaluate changes in pain intensity, functional capacity, fear of movement (kinesiophobia), pain catastrophizing, as well as symptoms of anxiety and depression. Although study participants will not be randomized, the results will be compared to a matched reference group drawn from the Swedish Quality Registry for Pain Rehabilitation (SQRP). This reference group, comprising individuals who have undergone standard multimodal pain rehabilitation, is included to provide a contextualizing indication of whether PRT is associated with clinically relevant changes in the outcome measures.

The project is designed as a single-arm pilot study in which all participants will receive PRT. Data collection will occur at baseline, during the intervention, and post-treatment. PRT, which has previously been evaluated primarily in a selected population with chronic back pain and limited comorbidity, aims to modify the patient's interpretation of the cause of their pain and its perceived threat value. By targeting fear-avoidance responses triggered by somatic signals, the ultimate objective of the treatment is to facilitate sustained symptom relief.

Primary Objective:

The primary objective is to investigate whether a 9-week treatment with Pain Reprocessing Therapy (PRT) meets predefined criteria for feasibility and acceptability.

Primary Research Questions:

  • Is an adequate recruitment rate achieved among approached patients?
  • Does a sufficiently large proportion of the included participants complete the treatment program (retention rate)?
  • Does the treatment demonstrate adequate patient satisfaction?
  • Are patient attendance and treatment adherence, in terms of completing homework assignments, consistent with predefined benchmarks?
  • Do the clinicians demonstrate adequate treatment fidelity to the PRT manual?

Secondary Objective:

The secondary objective is to exploratively investigate whether PRT is associated with changes in predefined clinical outcome measures.

Secondary Research Questions:

  • Are there observed changes in self-rated pain experience, quality of life, symptoms of anxiety and depression, fear of movement (kinesiophobia), pain-related catastrophizing, fatigue and sickness behavior?
  • How do changes in outcome measures following PRT compare to a matched reference group that has undergone standard multimodal pain rehabilitation?

Exploratory Research Questions:

  • Are participants' initial treatment expectations and perceived credibility , as well as their perception of clinician empathy, cognitive functioning and pain sensitivity associated with treatment outcomes?
  • How are cognitive function and pain sensitivity affected by the treatment?
  • How do participants describe their experiences of the treatment and perceived processes of change in qualitative interviews?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged 18 years and older.
  • Completed medical investigation regarding the pain diagnosis. Primary pain conditions (according to ICD-11) or nociplastic pain, as well as mixed conditions where patients have nociplastic pain combined with nociceptive and/or neuropathic pain (e.g., fibromyalgia, chronic widespread pain, primary chronic back pain).
  • Pain duration of at least 3 months.
  • Current medication regimen compatible with participating in and benefiting from highly specialized rehabilitation.
  • Ability to read, speak, and understand the Swedish language.
  • Exclusion Criteria:
  • Severe psychiatric conditions (e.g., psychosis, severe depression, and suicidality).
  • Current substance abuse (including overuse of prescription medications) or dementia.
  • Cancer pain, cauda equina syndrome, or other medical conditions that constitute the primary explanation for the patient's pain.
  • Another psychological treatment for pain within the past 3 months.
  • Ongoing parallel treatments related to the patient's pain at other clinics, with the exception of ongoing pharmacological treatment.
  • Ongoing legal disputes or active claims for disability compensation.

Treatment and study plan

Pain Reprocessing Therapy

Behavioral

A 9-week intervention with 9 individual sessions and 3 group sessions based on Pain Reprocessing Therapy.

Primary outcomes

  1. Retention rate

    Time frame: From enrollment to 9 weeks (post treatment).

    The retention rate is defined as the percentage of participants who successfully complete the PRT intervention. To be considered a completer, a participant must attend at least 6 of the 9 individual sessions and complete all post-treatment outcome measures. The benchmark for study feasibility is set at 75%

  2. Recruitment rate

    Time frame: From study start to recruitment completion, an estimated 6 months

    Feasibility of recruitment, defined as percentage of eligible participants who give informed consent and are enrolled in the study. The predefined benchmark for feasibility of recruitment rate is set as at least 70%

  3. Patient treatment satisfaction

    Time frame: Post treatment (9 weeks)

    Assessed using the Client Satisfaction Questionnaire (CSQ-8). The total score ranges from 8 to 32. Higher scores indicate greater satisfaction with the treatment received, representing a better outcome. The predefined benchmark for acceptability is set to a mean total score of 24 or higher (out of a maximum of 32).

  4. Adherence to treatment

    Time frame: From enrollment to the end of the treatment at 9 weeks

    Adherence to the in-between session work with home assignments, as logged by the therapists during the 9-week program. The predefined benchmark for adequate adherence is at least 70% of assigned homework tasks.

  5. Therapists treatment fidelity

    Time frame: From treatment start to the end of treatment at 9 weeks

    The degree to which the therapists adhere to the core interventions of the treatment. Evaluated by therapist self-report using a study-specific PRT fidelity checklist completed after each session. The predefined benchmark for adequate treatment fidelity is set to an average adherence score of at least 80%.

Secondary outcomes

  1. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline and week 9

    The PCS assesses negative thoughts and emotions associated with past, present or anticipated pain. The total score ranges from 0 to 52. Higher scores indicate greater levels of pain catastrophizing.

  2. Tampa Scale of Kinesiophobia (TSK)

    Time frame: Baseline and week 9

    The TSK assesses fear of movement or re-injury. The 17-item version is used. Total scores range from 17 to 68. Higher scores indicates a higher degree of kinesiophobia.

  3. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Baseline and week 9

    The HADS scale measures anxiety and depression symptoms. The HADS contains of 14 items, divided into 2 subscales (anxiety and depression). For each subscale, the total score ranges from 0 to 21. Higher scores indicate greater severity of anxiety and depression symptoms.

  4. EQ-5D

    Time frame: Baseline and week 9 (post treatment)

    The EQ-5D measures health-related quality of life across five dimensions. Responses are converted into a single index score. The index score typically ranges from a minimum of less than 0 (often around -0.59, representing a health state worse than death) to a maximum of 1.0 (representing full health). Higher index scores indicate a better health-related quality of life.

  5. EQ-5D VAS

    Time frame: Baseline to 9 week (post treatment)

    Measures self-rated overall health using a Visual Analogue Scale (EQ-VAS). Participants rate their overall health using a vertical visual analogue scale rangeing from 0-100. Higher scores indicates a better self-percieved health.

  6. Sickness Questionnaire (SicknessQ)

    Time frame: Baseline and week 9.

    The SicknessQ assesses self-reported sickness behavior (e.g., fatigue, social withdrawal. The scores ranges from 0 tp 30. Higher scores indicate a higher degree of sickness behavior.

  7. Multidimensional Fatigue Inventory (MFI-20)

    Time frame: Baseline to 9-week (post treatment)

    The MFI-20 assesses five dimensions of fatigue. The total score ranges from 20-100 where higher scores indicate higher levels of fatigue.

  8. Numeric Rating Scale For Pain

    Time frame: Baseline and week 9 (Post treatment)

    The NRS measures pain intensity where participants rate their pain intensity during the past week on an 11 point scale from 0 to 10. Higher scores indicate worse pain intensity.

  9. Consultation and Relational Empathy Measure (CARE)

    Time frame: Week 2 and 9 (post treatment)

    The CARE-scale assesses the participants perception of the therapists empathy during sessions. The maximum score is 50. Higher scores indicate greater percieved empathy from the treating clinician

  10. Credibility/Expectancy Questionnaire (CEQ)

    Time frame: Week 2

    The CEQ assesses how logical the treatment seems to the patient, and how much improvement they expect. Scores for each subscale range from 3 to 27. Higher scores indicate higher perceived credibility and expectancy of clinical improvement.

Other outcomes

  1. Pressure Pain Threshold (PPT)

    Time frame: Baseline and 9-week

    Assessed using a pressure algometer. Measures are recorded in kPa at predefined anatomical sites. Higher values indicate higher pain thresholds.

  2. Thermal Pain Thresholds

    Time frame: Baseline and week 9 (Post treatment)

    Assessed using a computerized thermotest device. Heat Pain Threshold (HPT) and Cold Pain Threshold (CPT) are measured in degrees Celcius. For HPT, higher temperatures indicate a higher pain threshold. For CPT, lower temperatures indicate a higher pain threshold.

  3. PrePain Questionnaire

    Time frame: Before treatment start and 9 weeks (post treatment)

    The PrePain questionnaire assesses attitudes, emotions and behaviors related to pain. The six dimensional questions (assessing perceived pain-sensitivity, avoidance, distress, relief, focus on symptoms, and negative thoughts) are analyzed individually rather than as a total score. Each item is scored on a Visual Analog Scale (VAS) with a minimum value of 0 and a maximum value of 100. A VAS-score of 100 means respectively low pain-sensitivity, low degree of avoidance, low degree of distress, low degree of relief, low degree focus on symptoms and low degree of negative thoughts. Because higher scores represent a lower degree of these pain-related attitudes and emotions, higher scores indicate a better outcome.

  4. Stroop-test

    Time frame: Baseline and 9 weeks (post treatment)

    Executive control, attention, and inhibition are assessed using a digital version of the Stroop test administered via the 'Health Catcher' application. Participants are instructed to respond to the color of a written word rather than the word itself. Performance is measured by the total number of correct responses completed within a 90-second time limit. The minimum possible score is 0. There is no predefined maximum score, as the total number of items presented depends on the participant's response speed. Higher scores (more correct responses within the time limit) indicate better cognitive performance and inhibition.

  5. Go/no-go Test

    Time frame: Baseline and 9 weeks (post treatment)

    Sustained attention and response inhibition are assessed using a digital Go/no-go test administered via the 'Health Catcher' application. Participants respond to a target stimulus while withholding responses to a non-target stimulus. Performance is measured by the total number of correct responses completed within a 90-second time limit. The minimum possible score is 0. There is no predefined maximum score, as the total number of items presented depends on the participant's response speed. Higher scores (more correct responses within the time limit) indicate better sustained attention and response inhibition.

  6. Verbal Recognition Memory Test

    Time frame: Baseline and 9 weeks (post treatment)

    Verbal episodic memory is assessed using a digital verbal recognition memory test administered via the 'Health Catcher' application. Participants report whether mixed lists of words were included in a previously presented sequence. Performance is measured by the total score of correct recognitions. The score ranges from a minimum of 0 to a maximum of 24. Higher scores indicate better memory function.

  7. Visual Working Memory Test

    Time frame: Baseline and 9 weeks (post treatment)

    Visuospatial working memory and attention are assessed using a digital visual working memory test administered via the 'Health Catcher' application. Participants memorize and reproduce sequences of illuminated squares in a 4x4 grid. Performance is measured by the total score of correctly identified locations. The score ranges from a minimum of 0 to a maximum of 6. Higher scores indicate better visuospatial working memory, representing a better outcome

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Breaking the Pain Cycle: Implementing a Novel Neuroscience-based Behavioral Therapy for Chronic Pain in a Pain Rehabilitation Setting

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 27, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.