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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Other: PNE4Adults

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Region Zeland
    • Køge, Region Zeland, Denmark, 4600
      • Køge Kommune

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual care; Participants will initially undergo 2 weeks of usual care.	Other: PNE4Adults; 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.
Experimental: PNE4Adults; Participants will undergo 2 sessions (1-2 weeks) where they will be introduced to the PNE4Adult board.	Other: PNE4Adults; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aalborg University
• Collaborators: Vrije Universiteit Brussel; Municipality of Koege, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2021
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): April 1, 2022

Study Registration Dates

• First Submitted: November 6, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): December 1, 2021

Study Record Updates

• Last Update Posted (Actual): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Keeping it simple

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No