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Completed

NCT Number: NCT07764848

Physiotherapy Intervention Program for Chronic Pain Associated With Depressive Disorder

This prospective longitudinal pre-post intervention study aims to evaluate the effects of an 8-week physiotherapy program combining face-to-face and asynchronous tele-rehabilitation sessions in individuals with chronic persistent pain and depressive disorder. The intervention is based on pain neuroscience education and therapeutic exercise. Outcomes include pain intensity, psychosocial factors, adherence to treatment, usability of telemedicine, balance, body awareness, and participants' experiences collected through focus groups.

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Key information

Conditions

Chronic Pain Depressive Disorder Mental Disorders Mood Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Persistent Pain Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zaragoza University and San Jorge University

Zaragoza, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 45-75 years
  • User of AFDA and ASAPME
  • Chronic persistent pain
  • Written informed consent provided

Exclusion criteria

  • Severe psychiatric disorders (including schizophrenia)
  • Neurological diseases preventing participation
  • No internet access
  • Mini-Mental State Examination score ≤24
  • Acute musculoskeletal disorders
  • Rheumatic diseases
  • Severe respiratory insufficiency
  • Inability to understand Spanish
  • Pregnancy, immunosuppression, transplantation or active oncological condition

Treatment and study plan

Hybrid Physiotherapy Program

Other

Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise:

Behavioral: Pain Neuroscience Education Eight weekly face-to-face educational sessions complemented by asynchronous telematic educational videos covering pain neurophysiology, biopsychosocial approaches, neuroplasticity, motor imagery and self-management strategies.

Behavioral: Therapeutic Exercise Eight weeks of supervised group exercise. Exercises include strength, aerobic, balance, flexibility, coordination and dual-task activities.

Primary outcomes

  1. Pain Intensity (Numering Rating Scale)

    Time frame: Baseline and Week 8

Secondary outcomes

  1. Pain Catastrophizing Scale

    Time frame: Baseline and Week 8

  2. Chronic Pain Coping Questionnaire

    Time frame: Baseline and Week 8

  3. Tampa Scale for Kinesiophobia (TSK-11)

    Time frame: Baseline and Week 8

  4. Chronic Pain Self-Efficacy Questionnaire

    Time frame: Baseline and Week 8

  5. Depression Anxiety Stress Scale (DASS-21)

    Time frame: Baseline and Week 8

  6. Fear Avoidance Beliefs Questionnaire (FABQ)

    Time frame: Baseline and Week 8

  7. Clinical Global Impression Scale (CGI)

    Time frame: Baseline and Week 8

  8. Qualitative outcomes from focus groups

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria Aragón

Other

Collaborators

  • Universidad San Jorge

Registry information

Official study title

Effects of a Hybrid Physiotherapy Program Based on Pain Neuroscience Education and Therapeutic Exercise in Individuals With Chronic Persistent Pain and Depressive Disorder: A Prospective Longitudinal Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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