Chronic Musculoskeletal PainNCT06653114
Development and Evaluation of an Educational Program for the Management of Chronic Musculoskeletal Pain
A study testing Education in Chronic Musculoskeletal Pain and Education in Communication Skills in people with Chronic Musculoskeletal Pain and Clinical Communication, run by University of Thessaly at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Musculoskeletal Pain, Clinical Communication
- What is being tested?
- Education in Chronic Musculoskeletal Pain and Education in Communication Skills
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteGreece
- Study dates
- 19 Oct 2024to 11 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physiotherapists registered with the Panhellenic Association of Physiotherapists
- >2 years of clinical experience with chronic musculoskeletal patients
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Education in Chronic Musculoskeletal Pain, Education in Communication Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education in Chronic Musculoskeletal PainOther
Improving Knowledge and Skills in Chronic Musculoskeletal Pain (Assessment and Management)
Education in Communication SkillsOther
Developing Communication Skills (Empathy, Motivational Interviewing, Shared Decision-making)
| Study group | Role | What they receive |
|---|---|---|
| Chronic Musculoskeletal Pain + Communication skills | Experimental | Participants will complete both parts of the educational program (assessment and management of chronic musculoskeletal pain and development of communication skills). Receives: Other: Education in Chronic Musculoskeletal Pain; Other: Education in Communication Skills |
| Chronic Musculoskeletal Pain | Experimental | Participants will complete only the management of chronic musculoskeletal pain portion of the educational program. Receives: Other: Education in Communication Skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Baseline in Knowledge on Pain (the Knowledge and Perceptions about Pain (KNAP) Questionnaire at Week 5 and Week 12
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.
Measured: 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
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.
Measured: Baseline, Week 5 and Week 16
Change on Baseline in Empathy (The Toronto Components Empathy Questionnaire (ECQ) at Week 5 and Week 12
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.
Measured: 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
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").
Measured: 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
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.
Measured: Baseline, Week 5 and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start19 Oct 2024
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Konstantina Savvoulidou, University of Thessaly
- Investigators
- Eleni V Kapreli, Prof, Study director, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653114
- Sponsor's protocol ID
- 12
- Status last verified
- Mar 2025
- First submitted
- 19 Oct 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06653114
- Acronym / sponsor ID
- 12
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Study start
- 19 Oct 2024 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 22 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Musculoskeletal Pain + Communication skills | Experimental | Other: Education in Chronic Musculoskeletal Pain, Other: Education in Communication SkillsParticipants will complete both parts of the educational program (assessment and management of chronic musculoskeletal pain and development of communication skills). |
| Chronic Musculoskeletal Pain | Experimental | Other: Education in Communication SkillsParticipants will complete only the management of chronic musculoskeletal pain portion of the educational program. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Physiotherapists registered with the Panhellenic Association of Physiotherapists
- >2 years of clinical experience with chronic musculoskeletal patients
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education in Chronic Musculoskeletal PainImproving Knowledge and Skills in Chronic Musculoskeletal Pain (Assessment and Management) | Other | Chronic Musculoskeletal Pain + Communication skills |
| Education in Communication SkillsDeveloping Communication Skills (Empathy, Motivational Interviewing, Shared Decision-making) | Other | Chronic Musculoskeletal Pain, Chronic Musculoskeletal Pain + Communication skills |
Primary outcome
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.
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.
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.
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").
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleni V Kapreli, Prof study director
University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in Chronic Musculoskeletal Pain and Education in Communication Skills in people with Chronic Musculoskeletal Pain and Clinical Communication, run by University of Thessaly at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025; AzTrials last refreshed its copy on 29 Oct 2026.