Effectiveness of Communication-Focused Pain Neuroscience Education in Chronic Musculoskeletal Pain
NCT ID: NCT07001449
Last Updated: 2025-07-15
Study Results
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Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-06-17
2025-10-30
Brief Summary
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Detailed Description
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Eligible participants will be men and women aged 18 to 65 years, diagnosed with chronic musculoskeletal pain in the lumbar spine, neck, shoulder, or knee for more than 3 months, reporting a pain intensity ≥3/10 on the Numeric Pain Rating Scale (NPRS), and experiencing symptoms on most days of the week. All participants must be fluent in the Greek language. Exclusion criteria include acute pain, neurological or neuromuscular disorders, malignancy, recent surgeries or fractures within the past year, fibromyalgia, pregnancy, corticosteroid use, cognitive impairments that affect communication or questionnaire completion, or participation in other therapeutic programs during the study period.
Participants will be randomized into one of three groups:
Experimental Group 1: Participants will receive individualized PNE-based physiotherapy delivered by physiotherapists who have completed the full "Algo(S)Therapy" program, which includes both pain neuroscience and communication skills training specific to managing patients with chronic pain.
Experimental Group 2: Participants will receive the same PNE-based physiotherapy intervention, but from physiotherapists who have completed only the pain neuroscience component of the "Algo(S)Therapy" program. These therapists will not have received any training in communication skills or related modules.
Control Group will receive standard physiotherapy treatment without any exposure to PNE or communication-focused training.
All therapists in the experimental groups will have at least two year of experience treating patients with chronic musculoskeletal pain and will be selected based on performance in the "Algo(S)Therapy" training program. The intervention for all groups will last five weeks, with two sessions per week (total of 10 sessions).
The study will utilize validated outcome measures to evaluate pain, function, psychosocial variables, and therapeutic alliance. These include:
Numeric Pain Rating Scale (NPRS) Pain drawings (APDs) Central Sensitization Inventory (CSI) Pain Catastrophizing Scale (PCS) Tampa Scale for Kinesiophobia (TSK) Brief Illness Perception Questionnaire (B-IPQ) Pain Self-Efficacy Questionnaire (PSEQ) Pittsburgh Sleep Quality Index (PSQI) State-Trait Anxiety Inventory (STAI) Oswestry Disability Index (ODI) Working Alliance Inventory - Short Revised (WAI-SR) Satisfaction of treatment (Global Rating of Change - GroC) Days with disability (Recorded in an electronic data collection notebook) Adherence to Intervention (Recorded electronically) Adverse Effects (Recorded electronically)
Assessments will be conducted at three time points: baseline (pre-intervention), post-intervention, and 3-month follow-up. Statistical analysis will include repeated measures ANOVA to evaluate within- and between-group differences over time. The required sample size of 90 participants was calculated using G\*Power, accounting for an estimated 10% dropout rate.
The main goal of this study is to determine whether the inclusion of communication training in a PNE-based physiotherapy program can significantly enhance clinical outcomes in patients with chronic musculoskeletal pain, compared to PNE alone or standard care.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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PNE + Communication Skills
Participants in this group will receive an individualized Pain Neuroscience Education (PNE) program plus usual physiotherapy care delivered by physiotherapists who completed the full "Algo(S)Therapy" training. This training included education in the neurophysiology of pain, assessment and management of chronic musculoskeletal pain, as well as the development and application of communication skills. The communication training focused on strategies such as motivational interviewing, empathy, active listening, and patient-centered interaction specifically tailored for individuals with chronic pain. The intervention will be administered over a 5-week period, with 2 sessions per week.
Pain Neuroscience Education with Communication Training
This intervention includes individualized physiotherapy based on a Pain Neuroscience Education (PNE) framework delivered by physiotherapists who completed the full "Algo(S)Therapy" training program. The training includes education in the neurophysiology of pain, clinical reasoning for chronic musculoskeletal pain management, and structured communication skills development (e.g., motivational interviewing, empathy, active listening). The intervention is delivered twice per week over 5 weeks (10 sessions total).
PNE without Communication Training
Participants in this group will receive an individualized Pain Neuroscience Education (PNE) intervention plus usual physiotherapy care, delivered by physiotherapists who completed only the pain neurophysiology and clinical management components of the "Algo(S)Therapy" program. These physiotherapists did not receive any formal training in communication skills, such as motivational interviewing or empathy techniques. The intervention will be administered over a 5-week period, with 2 sessions per week.
Pain Neuroscience Education without Communication Training
A structured PNE program focusing on the neurophysiology and clinical management of chronic musculoskeletal pain. Delivered by physiotherapists trained only in the scientific modules of the "Algo(S)Therapy" program. Does not include communication skills training. Includes 10 sessions (2/week for 5 weeks), alongside standard physiotherapy care.
Usual Physiotherapy Treatment
Participants in this group will receive usual physiotherapy care. Physiotherapists in this group have not received any training in Pain Neuroscience Education or communication techniques related to chronic pain management. No components of the "Algo(S)Therapy" program will be applied in this group.
Usual Physiotherapy Treatment
Usual care based on medical referral and physiotherapy assessment. Delivered by physiotherapists who have not received training in Pain Neuroscience Education or communication techniques. No components of the "Algo(S)Therapy" program are included.
Interventions
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Pain Neuroscience Education with Communication Training
This intervention includes individualized physiotherapy based on a Pain Neuroscience Education (PNE) framework delivered by physiotherapists who completed the full "Algo(S)Therapy" training program. The training includes education in the neurophysiology of pain, clinical reasoning for chronic musculoskeletal pain management, and structured communication skills development (e.g., motivational interviewing, empathy, active listening). The intervention is delivered twice per week over 5 weeks (10 sessions total).
Pain Neuroscience Education without Communication Training
A structured PNE program focusing on the neurophysiology and clinical management of chronic musculoskeletal pain. Delivered by physiotherapists trained only in the scientific modules of the "Algo(S)Therapy" program. Does not include communication skills training. Includes 10 sessions (2/week for 5 weeks), alongside standard physiotherapy care.
Usual Physiotherapy Treatment
Usual care based on medical referral and physiotherapy assessment. Delivered by physiotherapists who have not received training in Pain Neuroscience Education or communication techniques. No components of the "Algo(S)Therapy" program are included.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of chronic musculoskeletal pain in the lumbar spine, cervical spine, shoulder, or knee
* Pain duration longer than 3 months
* Pain intensity ≥3/10 on the Numeric Pain Rating Scale (NPRS)
* Pain present most days of the week
* Able to understand and speak the Greek language
Exclusion Criteria
* Neurological disorders or myopathies
* Chronic pain of non-musculoskeletal origin
* Active cancer diagnosis
* History of trauma, fractures, or surgery in the past year
* Pregnancy
* Diagnosis of fibromyalgia
* Cognitive impairments affecting communication or completion of questionnaires
* Current use of corticosteroid medication
* Participation in other treatment programs or alternative therapies during the study period
* Concurrent enrollment in another clinical trial
18 Years
65 Years
ALL
No
Sponsors
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University of Thessaly
OTHER
Responsible Party
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Konstantina Savvoulidou
PhD Candidate
Principal Investigators
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Eleni Kapreli, Professor
Role: STUDY_CHAIR
Physiotherapy Department, University of Thessaly, Greece
Locations
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Physiotherapy Department, University of Thessaly, Greece
Lamia, Central Greece, Greece
Countries
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Central Contacts
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Other Identifiers
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10841/25
Identifier Type: -
Identifier Source: org_study_id
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