Keeping It Simple - Implementing Pain Education for All

Study Overview
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Brief Summary
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Pain education has proven difficult to implement into clinical practice. In Denmark 4 out of 10 adults has inadequate health literacy levels. To avoid inequality in health care we need a new and accurate method to provide pain education to all who need it. In this study, existing concept of pain education is implemented into clinical practice for a group of chronic pain patients including those with low degrees of health literacy, and then evaluate its use from both patient and physiotherapist perspective.

Detailed Description
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The focus of this is project is to implement existing knowledge into clinical practice and to adapt and test a tool (i.e., PNE4Kids) that was initially developed to explain pain to children and their parents, for its potential to teach adults in pain about contemporary pain science in a way that takes into consideration those with low degrees of health literacy. Further, we want to test its feasibility in adult pain patients at a community-based rehabilitation center. It is expected that adult patients suffering from chronic pain will find the adapted PNE4Kids, named PNE4Adults, comprehendible, will benefit from this type of pain education in terms of increased pain knowledge and self-efficacy, and decreased pain-intensity and pain catastrophizing thoughts. It is also expected that physiotherapists will find the pain education program easy to engage with and to transfer into a clinical setting.

Official Title
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Keeping It Simple - Implementing Pain Education for All: a Clinical Cross-over Feasibility Study Among Chronic Pain Patients Referred to Community-based Rehabilitation

Conditions
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Chronic Pain

Intervention / Treatment
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* Other: PNE4Adults


Participation Criteria
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Eligibility Criteria
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Eligible patients are; Danish speaking adult patients (≥18 years) Patients with chronic musculoskeletal pain (pain ≥ 3 months).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: After a period of usual care for 2-4 weeks, we want to cross-over and add the pain education intervention. The pain education intervention is an add-on to usual care and consists of an individualized pain education program in the form of Danish PNE4Adults. The education program consists of two session of +/- 1 hour each tailored individually to the needs of the patient. After the pain education, the patient will continue the planned rehabilitation program, but will integrate the knowledge obtained through the pain education, as an integrated part of the PNE4Adults program.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Participants will initially undergo 2 weeks of usual care. | Other: PNE4Adults<br>* It is a clear and concise program, that consists of a manual for the physiotherapist delivering the education and a board game to enhance engagement and participant involvement. It not only provides the physiotherapist with a clear how-to manual but also provides an easy and accessible way for the patient to grasp the difficult and complex concept of pain.<br>|
| Experimental: PNE4Adults<br>Participants will undergo 2 sessions (1-2 weeks) where they will be introduced to the PNE4Adult board. | Other: PNE4Adults<br>* It is a clear and concise program, that consists of a manual for the physiotherapist delivering the education and a board game to enhance engagement and participant involvement. It not only provides the physiotherapist with a clear how-to manual but also provides an easy and accessible way for the patient to grasp the difficult and complex concept of pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of the PNE4Adults | Acceptability of the combined intervention of PNE4Adults and usual care will be measured by a participant acceptability questionnaire on a 7-point Likert scale ranging from very unacceptable, unacceptable, slightly unacceptable, neither unacceptable nor acceptable, slightly acceptable, acceptable, and very acceptable. | During the final consultation, after approximeatly 6 weeks | 
| Comprehensibility of the PNE4Adults | How comprehensible the PNE4Adults is, will be measured by a participant questionnaire on a 7-point Likert scale ranging from very incomprehensible, comprehensible, slightly incomprehensible, neither incomprehensible nor comprehensible, slightly comprehensible, comprehensible, and very comprehensible. | During the final consultation, after approximeatly 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concept of Pain Inventory (COPI-adult) | To assess adults' beliefs and knowledge of pain science, a Danish version of the Concept of Pain Inventory (COPI-adult) is used. It is a 13-item self-reported questionnaire with the following response options; strongly disagree, disagree, unsure, agree, strongly agree. | T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care | 
| Pain Self-Efficacy scale, | A questionnaire which measures how confident a person feels in dealing with everyday life despite having chronic pain. The PSEQ consists of 10 items, rated on a 7-point Likert scale ranging from 0 (not confident at all) to 6 (very confident). | T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care | 
| Pain intensity | Pain intensity is assessed on Numeric Rating Scale (NRS) with answer options ranging from 0 = (no pain) to 10 = (worst imaginable pain). We will collect average pain intensity last 24 hours (NRSavg), worst pain intensity last 24 hours (NRSmax) and current pain intensity (NRScur) as they all seem to convey different aspects of pain and together provide a more accurate measure of pain. | T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care | 
| Pain Catastrophizing Scale | A questionnaire to assess catastrophizing in relation to actual or anticipated pain. The questionnaire has 3 sub-scales (i.e., rumination, magnification, and helplessness) and contains a total of 13-items. Patients use the same 5-point Likert-scale to respond to all 13 items ranging from not at all to very much so | T0: Baseline, T1: at 2-3 weeks of usual care, T2: at one week after two sessions of PNE4Adults, T3: at additional 2-3 weeks of usual care |