Keeping It Simple - Implementing Pain Education for All

NCT05140031 | Completed

• 1 other identifier: Keeping it simple
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

• 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

• 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 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

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Participants will initially undergo 2 weeks of usual care.

Other: PNE4Adults

PNE4Adults

EXPERIMENTAL

Participants will undergo 2 sessions (1-2 weeks) where they will be introduced to the PNE4Adult board.

Other: PNE4Adults

Interventions

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.

PNE4Adults; Usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Aalborg University: lead
• Municipality of Koege, Denmark: collaborator
• Vrije Universiteit Brussel: collaborator

Study Sites (1)

Køge Kommune

Køge, Region Zeland, 4600, Denmark

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: This study is designed as a cross-over study. As such, all participants will receive usual care before being introduced to the PNE4Adults board.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ms.c, Ph.d. student

Model Details: 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.

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 1, 2021
• Study Start: November 4, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)