Clinical trial NCT07001449: Effectiveness of Communication-Focused Pain Neuroscience Education in Chronic Musculoskeletal Pain
Official title: Effectiveness of the 'Algo(S)Therapy' Pain Neuroscience Education Program Emphasizing Physiotherapists' Communication Skills in Patients With Chronic Musculoskeletal Pain: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Musculoskeletal Pain
Keywords: Pain neuroscience education
Communication skills
Chronic musculoskeletal pain
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2025-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial aims to evaluate the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in patients with chronic musculoskeletal pain. The study will assess whether the integration of communication skills training for physiotherapists enhances the outcomes of PNE. Participants will be randomly assigned to one of three groups: (1) PNE with communication-focused delivery, (2) PNE without communication emphasis, or (3) standard- usual physiotherapy care. The primary objective is to determine whether PNE combined with enhanced communication skills leads to greater improvements in pain, function, and psychosocial outcomes compared to the other interventions.

Detailed description: 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) 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.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 to 65 years
* 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:

* Acute pain in any body region
* 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

Primary outcomes:
measure: Numeric Pain Rating Scale - NPRS
timeFrame: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up
Secondary outcomes:
measure: Central Sensitisation Inventory (CSI)
timeFrame: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up
measure: Tampa Scale for Kinesiophobia (TSK)
timeFrame: Baseline, Post-intervention (Week 5), and 3-Month Follow-Up
measure: Pain Sensitivity Questionnaire (PSQ)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: Pain Self-Efficacy Questionnaire (PSEQ)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: Brief Illness Perception Questionnaire (B-IPQ)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: Oswestry Disability Index (ODI)
timeFrame: Baseline, Week 5, and 3-Month Follow-Up
measure: Working Alliance Inventory - Short Revised (WAI-SR)
timeFrame: Week 5 (Post-intervention only)
measure: Satisfaction with Treatment (Global Rating of Change - GROC)
timeFrame: Post-intervention (Week 5) and 3-Month Follow-Up
measure: Pain Medication Consumption
timeFrame: Weekly during the 5-week intervention and at 3-Month Follow-Up
measure: Days with Disability
timeFrame: Recorded weekly during the 5-week intervention and at 3-Month Follow-Up
measure: Adherence to Intervention
timeFrame: Throughout the 5-week intervention period
measure: Adverse Effects
timeFrame: Monitored continuously throughout the 5-week intervention
Other outcomes:
Locations:
city: Lamia
country: Greece
facility: Physiotherapy Department, University of Thessaly, Greece
state: Sterea Ellada
Study officials:
affiliation: Physiotherapy Department, University of Thessaly, Greece
name: Eleni Kapreli, Professor
role: STUDY_CHAIR
References: