About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

25 Participants

are divided into 1 treatment group

Group A: Pain Reprocessing TherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Retention rate

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%

Time frame

From enrollment to 9 weeks (post treatment).

2

Recruitment rate

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%

Time frame

From study start to recruitment completion, an estimated 6 months

3

Patient treatment satisfaction

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).

Time frame

Post treatment (9 weeks)

4

Adherence to treatment

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.

Time frame

From enrollment to the end of the treatment at 9 weeks

Secondary outcomes

1

Pain Catastrophizing Scale (PCS)

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.

Time frame

Baseline and week 9

2

Tampa Scale of Kinesiophobia (TSK)

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.

Time frame

Baseline and week 9

3

Hospital Anxiety and Depression Scale (HADS)

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.

Time frame

Baseline and week 9

4

EQ-5D

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.

Time frame

Baseline and week 9 (post treatment)

Other outcomes

1

Pressure Pain Threshold (PPT)

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

Time frame

Baseline and 9-week

2

Thermal Pain Thresholds

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.

Time frame

Baseline and week 9 (Post treatment)

3

PrePain Questionnaire

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.

Time frame

Before treatment start and 9 weeks (post treatment)

4

Stroop-test

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.

Time frame

Baseline and 9 weeks (post treatment)

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

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