Clinical trial NCT06653114: Development and Evaluation of an Educational Program for the Management of Chronic Musculoskeletal Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Clinical Communication
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change on Baseline in Knowledge on Pain (the Knowledge and Perceptions about Pain (KNAP) Questionnaire at Week 5 and Week 12
timeFrame: Baseline, Week 5 and Week 16
measure: Change on Baseline in Knowledge on Pain (The Revised Neurophysiology of Pain Questionnaire (R-NPQ) at Week 5 and Week 12
timeFrame: Baseline, Week 5 and Week 16
measure: Change on Baseline in Empathy (The Toronto Components Empathy Questionnaire (ECQ) at Week 5 and Week 12
timeFrame: Baseline, Week 5 and Week 16
measure: Change on Baseline in using of Share Decision-Making (Shared Decision-Making Questionnaire (SDM-Q-9) at Week 5 and Week 12
timeFrame: Baseline, Week 5 and Week 16
measure: Change on Baseline in communication and clinical skills using an objective structured clinical examination (OSCE) at Week 5 and Week 12
timeFrame: Baseline, Week 5 and Week 16
Secondary outcomes:
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: University of Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni V Kapreli, Prof
role: STUDY_DIRECTOR
References: