Skip to main content
OpenTrials
Completed

NCT Number: NCT05140031

Keeping It Simple - Implementing Pain Education for All

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.

Completed

Looking for future studies?

Notify Me

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

Køge Kommune

Køge, Region Zeland, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

PNE4Adults

Other

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.

Primary outcomes

  1. Acceptability of the PNE4Adults

    Time frame: During the final consultation, after approximeatly 6 weeks

    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".

  2. Comprehensibility of the PNE4Adults

    Time frame: During the final consultation, after approximeatly 6 weeks

    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".

Secondary outcomes

  1. Concept of Pain Inventory (COPI-adult)

    Time frame: 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

    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".

  2. Pain Self-Efficacy scale,

    Time frame: 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

    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").

  3. Pain intensity

    Time frame: 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 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.

  4. Pain Catastrophizing Scale

    Time frame: 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

    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"

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Municipality of Koege, Denmark
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 1, 2021
Registry last updated
May 9, 2022

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.