NCT07001449

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

May 22, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 3, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

June 17, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 7, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

May 22, 2025

Last Update Submit

April 30, 2026

Conditions

Keywords

Pain neuroscience educationCommunication skillsChronic musculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • Numeric Pain Rating Scale - NPRS

    Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), where participants rate their average pain on a scale from 0 (no pain) to 10 (worst imaginable pain). The measure will be used to determine the effectiveness of each intervention in reducing chronic musculoskeletal pain.

    Baseline, Post-intervention (Week 5), and 3-Month Follow-Up

Secondary Outcomes (14)

  • Central Sensitisation Inventory (CSI)

    Baseline, Post-intervention (Week 5), and 3-Month Follow-Up

  • Pain Catastrophizing Scale (PCS)

    Baseline, Post-intervention (Week 5), and 3-Month Follow-Up

  • Tampa Scale for Kinesiophobia (TSK)

    Baseline, Post-intervention (Week 5), and 3-Month Follow-Up

  • Pain Sensitivity Questionnaire (PSQ)

    Baseline, Week 5, and 3-Month Follow-Up

  • Pain Self-Efficacy Questionnaire (PSEQ)

    Baseline, Week 5, and 3-Month Follow-Up

  • +9 more secondary outcomes

Study Arms (3)

PNE + Communication Skills

EXPERIMENTAL

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.

Behavioral: Pain Neuroscience Education with Communication Training

PNE without Communication Training

EXPERIMENTAL

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.

Behavioral: Pain Neuroscience Education without Communication Training

Usual Physiotherapy Treatment

ACTIVE COMPARATOR

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.

Behavioral: Usual Physiotherapy Treatment

Interventions

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 + Communication Skills

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.

PNE without Communication Training

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.

Usual Physiotherapy Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBoth men and women aged 18 to 65 years, who meet the inclusion criteria for chronic musculoskeletal pain, are eligible for participation in this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiotherapy Department, University of Thessaly, Greece

Lamia, Central Greece, 35100, Greece

RECRUITING

Study Officials

  • Eleni Kapreli, Professor

    Physiotherapy Department, University of Thessaly, Greece

    STUDY CHAIR

Central Study Contacts

Konstantina Savvoulidou

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Candidate

Study Record Dates

First Submitted

May 22, 2025

First Posted

June 3, 2025

Study Start

June 17, 2025

Primary Completion (Estimated)

August 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 7, 2026

Record last verified: 2026-04

Locations