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

Not Applicable

Completed

• Conditions: Chronic Musculoskeletal Pain; Clinical Communication

• Registration Number: NCT06653114
• Lead Sponsor: University of Thessaly

Brief Summary

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.

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 Timeline

• Study Start: 2024-10-19
• Study First Submitted: 2024-10-19
• Study First Submitted QC: 2024-10-19
• Study First Posted: 2024-10-22
• Primary Completion: 2025-01-11
• Study Completion: 2025-01-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change on Baseline in Knowledge on Pain (the Knowledge and Perceptions about Pain (KNAP) Questionnaire at Week 5 and Week 12	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.
Change on Baseline in Knowledge on Pain (The Revised Neurophysiology of Pain Questionnaire (R-NPQ) at Week 5 and Week 12	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.
Change on Baseline in Empathy (The Toronto Components Empathy Questionnaire (ECQ) at Week 5 and Week 12	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.
Change on Baseline in using of Share Decision-Making (Shared Decision-Making Questionnaire (SDM-Q-9) at Week 5 and Week 12	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").
Change on Baseline in communication and clinical skills using an objective structured clinical examination (OSCE) at Week 5 and Week 12	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.

Trial Locations

Locations (1)

University of Thessaly; 🇬🇷 Lamia, Greece