Effectiveness of Communication-Focused Pain Neuroscience Education in Chronic Musculoskeletal Pain

This randomized controlled trial investigates the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in the management of chronic musculoskeletal pain (CMP), with a focus on the added value of physiotherapists' communication skills. The study will be conducted in accordance with the CONSORT guidelines.

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) Pain Disability Index (PDI) 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.

• Central Sensitisation Inventory (CSI) [Срок оценки: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up]
• Pain Catastrophizing Scale (PCS) [Срок оценки: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up]
• Tampa Scale for Kinesiophobia (TSK) [Срок оценки: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up]
• Pain Sensitivity Questionnaire (PSQ) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• Pain Self-Efficacy Questionnaire (PSEQ) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• Brief Illness Perception Questionnaire (B-IPQ) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• State-Trait Anxiety Inventory (STAI) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• Pain Disability Index (ODI) [Срок оценки: Baseline, Week 5, and 3-Month Follow-Up]
• Working Alliance Inventory - Short Revised (WAI-SR) [Срок оценки: Week 5 (Post-intervention only)]
• Satisfaction with Treatment (Global Rating of Change - GROC) [Срок оценки: Post-intervention (Week 5) and 3-Month Follow-Up]
• Pain Medication Consumption [Срок оценки: Weekly during the 5-week intervention and at 3-Month Follow-Up]