NCT07764848

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable chronic-pain

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

February 5, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2.3 years

First QC Date

August 10, 2026

Last Update Submit

August 10, 2026

Conditions

Chronic PainPersistent PainDepressive Disorder

Keywords

Chronic PainPersistent PainDepressive DisorderPhysical therapyTherapeutic exerciseNeuroscience education

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (Numering Rating Scale)

    Baseline and Week 8

Secondary Outcomes (8)

  • Pain Catastrophizing Scale

    Baseline and Week 8

  • Chronic Pain Coping Questionnaire

    Baseline and Week 8

  • Tampa Scale for Kinesiophobia (TSK-11)

    Baseline and Week 8

  • Chronic Pain Self-Efficacy Questionnaire

    Baseline and Week 8

  • Depression Anxiety Stress Scale (DASS-21)

    Baseline and Week 8

  • +3 more secondary outcomes

Study Arms (1)

Hybrid Physiotherapy Program

EXPERIMENTAL

Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise

Other: Hybrid Physiotherapy Program

Interventions

Hybrid Physiotherapy ProgramOTHER

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.

Hybrid Physiotherapy Program

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zaragoza University and San Jorge University

Zaragoza, Spain

Location

MeSH Terms

Conditions

Chronic PainDepressive Disorder

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMood DisordersMental Disorders

Study Officials

  • Sandra S Calvo, Phd

    University Zaragoza

    PRINCIPAL INVESTIGATOR

  • Carolina C Jiménez-Sánchez, Phd

    San Jorge University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
No Masking
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective pre-post study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

August 10, 2026

First Posted

August 14, 2026

Study Start

February 5, 2024

Primary Completion

May 30, 2026

Study Completion

May 30, 2026

Last Updated

August 14, 2026

Record last verified: 2026-08

Locations

ES(1)