Development and Evaluation of an Educational Program for the Management of Chronic Musculoskeletal Pain

March 16, 2025 updated by: Konstantina Savvoulidou, University of Thessaly

Development and Evaluation of an Educational Program for the Management of Chronic Musculoskeletal Pain, With an Emphasis on Pain Neuroscience and the Development of Communication Skills for Physiotherapists

A controlled randomized study will be conducted to assess the effectiveness of the educational program before and after its implementation. An invitation to participate will be extended to physiotherapists interested in the training program. More than 64 physiotherapists will be randomly assigned to two equal groups. All participants will sign an informed consent form before the commencement of the study and will be informed about the study's content, duration, and their right to withdraw at any time. A structured educational program consisting of two parts will be developed, encompassing three core modules (Part A) on the management of chronic pain and three core modules (Part B) on communication skills and techniques. The modules in Part A of the educational program will focus on elucidating the neurophysiological mechanisms of pain, performing differential assessments based on chronic musculoskeletal pain phenotypes, and addressing and managing the factors contributing to patients' pain experiences and rehabilitation, with a particular emphasis on pain neuroscience education. The modules in Part B of the educational program will concentrate on the development of communication skills essential for effective interaction between patients and physiotherapists. The first group will complete all modules of the educational program, while the second group (control group) will only participate in the Part A education modules. The effectiveness of the program will be evaluated before and after its implementation by two independent examiners through the administration of an Objective Structured Clinical Examination (OSCE) and the use of reliable and valid questionnaires and scales.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A controlled randomized study will be conducted to assess the effectiveness of the educational program before and after its implementation. An invitation to participate will be extended to physiotherapists interested in the training program. More than 64 physiotherapists will be randomly assigned to two equal groups. All participants will sign an informed consent form before the commencement of the study and will be informed about the study's content, duration, and their right to withdraw at any time. A structured educational program consisting of two parts will be developed, encompassing three core modules (Part A) on the management of chronic pain and three core modules (Part B) on communication skills and techniques. The modules in Part A of the educational program will focus on elucidating the neurophysiological mechanisms of pain, performing differential assessments based on chronic musculoskeletal pain phenotypes, and addressing and managing the factors contributing to patients' pain experiences and rehabilitation, with a particular emphasis on pain neuroscience education. The modules in Part B of the educational program will concentrate on the development of communication skills essential for effective interaction between patients and physiotherapists. The first group will complete all modules of the educational program, while the second group (control group) will only participate in the Part A education modules. The effectiveness of the program will be evaluated before and after its implementation by two independent examiners through the administration of an Objective Structured Clinical Examination (OSCE) and the use of reliable and valid questionnaires/scales. Upon completion of the program and its evaluation, participants in the control group will have the opportunity to complete the communication skills training as well.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Lamia, Greece, 35132
        • University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Physiotherapists registered with the Panhellenic Association of Physiotherapists
  • >2 years of clinical experience with chronic musculoskeletal patients

Exclusion Criteria:

  • Participants who have attended any educational program or seminar related to pain education, pain neuroscience education, or a training program related to improving communication skills lasting more than 6 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chronic Musculoskeletal Pain + Communication skills
Participants will complete both parts of the educational program (assessment and management of chronic musculoskeletal pain and development of communication skills).
Other: Education in Chronic Musculoskeletal Pain
Improving Knowledge and Skills in Chronic Musculoskeletal Pain (Assessment and Management)
Other: Education in Communication Skills
Developing Communication Skills (Empathy, Motivational Interviewing, Shared Decision-making)
Experimental: Chronic Musculoskeletal Pain
Participants will complete only the management of chronic musculoskeletal pain portion of the educational program.
Other: Education in Communication Skills
Developing Communication Skills (Empathy, Motivational Interviewing, Shared Decision-making)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Baseline in Knowledge on Pain (the Knowledge and Perceptions about Pain (KNAP) Questionnaire at Week 5 and Week 12
Time Frame: Baseline, Week 5 and Week 16
The Knowledge and Perceptions about Pain (KNAP) Questionnaire is a 30-item questionnaire. These questions are designed to assess various aspects of pain knowledge and beliefs, including the understanding of pain mechanisms, treatment approaches, and the impact of pain on individuals. It uses a Likert Scale (1 strongly disagree - 6 strongly agree). A higher KNAP score indicates that an individual's knowledge and attitudes about pain align more closely with current pain neuroscience.
Baseline, Week 5 and Week 16
Change on Baseline in Knowledge on Pain (The Revised Neurophysiology of Pain Questionnaire (R-NPQ) at Week 5 and Week 12
Time Frame: Baseline, Week 5 and Week 16
The revised Neurophysiology of Pain Questionnaire (R-NPQ) developed to assess knowledge about the biological and physiological mechanisms of pain. Created by Dr. Lorimer Moseley in 2003 and revised by Ostelo et al. 2013. It evaluates understanding of how the nervous system and brain process pain. The total score is the sum of points from all correctly answered questions.
Baseline, Week 5 and Week 16
Change on Baseline in Empathy (The Toronto Components Empathy Questionnaire (ECQ) at Week 5 and Week 12
Time Frame: Baseline, Week 5 and Week 16
The Toronto Components Empathy Questionnaire (ECQ) is designed to assess different aspects of empathy, particularly in clinical settings (Spreng et al., 2009). Developed to measure how individuals perceive and respond to others' emotions. 26 items are allocated for professional life, with an equal distribution between cognitive and emotional empathy.
Baseline, Week 5 and Week 16
Change on Baseline in using of Share Decision-Making (Shared Decision-Making Questionnaire (SDM-Q-9) at Week 5 and Week 12
Time Frame: Baseline, Week 5 and Week 16
The SDM-Q-9 is a validated 9-item questionnaire designed to evaluate patients' perceptions of shared decision-making (SDM) (Kriston et al., 2010). Each item represents a distinct step in the SDM process and is rated on a 6-point Likert scale from 0 ("completely disagree") to 5 ("completely agree").
Baseline, Week 5 and Week 16
Change on Baseline in communication and clinical skills using an objective structured clinical examination (OSCE) at Week 5 and Week 12
Time Frame: Baseline, Week 5 and Week 16
The Objective Structured Clinical Examination (OSCE) is a comprehensive and structured assessment to evaluate clinical skills and competencies in healthcare professionals. OSCE will be used to assess the following focused clinical skills of participants: history taking, gathering information, information provided in patients, empathy, share decision-making, motivational interviewing.
Baseline, Week 5 and Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Thessaly

Investigators

  • Study Director: Eleni V Kapreli, Prof, University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2024

Primary Completion (Actual)

January 11, 2025

Study Completion (Actual)

January 11, 2025

Study Registration Dates

First Submitted

October 19, 2024

First Submitted That Met QC Criteria

October 19, 2024

First Posted (Actual)

October 22, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 16, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12 (Israel lung Association)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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