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Keeping It Simple - Implementing Pain Education for All

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140031
Enrollment
20
Registered
2021-12-01
Start date
2021-11-04
Completion date
2022-04-01
Last updated
2022-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Brief summary

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

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.

Interventions

OTHERPNE4Adults

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.

Sponsors

Municipality of Koege, Denmark
CollaboratorUNKNOWN
Vrije Universiteit Brussel
CollaboratorOTHER
Aalborg University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Masking description

This study is designed as a cross-over study. As such, all participants will receive usual care before being introduced to the PNE4Adults board.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability of the PNE4AdultsDuring the final consultation, after approximeatly 6 weeksAcceptability 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.
Comprehensibility of the PNE4AdultsDuring the final consultation, after approximeatly 6 weeksHow 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.

Secondary

MeasureTime frameDescription
Concept of Pain Inventory (COPI-adult)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 careTo 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.
Pain Self-Efficacy scale,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 careA 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).
Pain intensityT0: 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 carePain 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.
Pain Catastrophizing ScaleT0: 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 careA 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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026