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Clinical Trials/NCT05140031
NCT05140031CompletedNot Applicable

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

Aalborg University1 site in 1 country20 target enrollmentStarted: November 4, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
Comprehensibility of the PNE4Adults

Study Overview

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.

Study Design

Study Type
Interventional
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.

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Usual care

Active Comparator

Participants will initially undergo 2 weeks of usual care.

Intervention: PNE4Adults (Other)

PNE4Adults

Experimental

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

Intervention: PNE4Adults (Other)

Outcomes

Primary Outcomes

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".

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".

Secondary Outcomes

  • 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)

Investigators

Sponsor
Aalborg University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Christian Lund Straszek

Ms.c, Ph.d. student

Aalborg University

Study Sites (1)

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