Keeping It Simple - Implementing Pain Education for All

Sponsor
Aalborg University (Other)
Overall Status
Completed
CT.gov ID
NCT05140031
Collaborator
Municipality of Koege, Denmark (Other), Vrije Universiteit Brussel (Other)
20
1
2
4.9
4.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: PNE4Adults
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
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.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)
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.
Primary Purpose:
Other
Official Title:
Keeping It Simple - Implementing Pain Education for All: a Clinical Cross-over Feasibility Study Among Chronic Pain Patients Referred to Community-based Rehabilitation
Actual Study Start Date :
Nov 4, 2021
Actual Primary Completion Date :
Apr 1, 2022
Actual Study Completion Date :
Apr 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Acceptability of the PNE4Adults [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 [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 Outcome Measures

  1. 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 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, [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 [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 [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"

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Køge Kommune Køge Region Zeland Denmark 4600

Sponsors and Collaborators

  • Aalborg University
  • Municipality of Koege, Denmark
  • Vrije Universiteit Brussel

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Christian Lund Straszek, Ms.c, Ph.d. student, Aalborg University
ClinicalTrials.gov Identifier:
NCT05140031
Other Study ID Numbers:
  • Keeping it simple
First Posted:
Dec 1, 2021
Last Update Posted:
May 9, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 9, 2022