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Clinical Trials/NCT07764848
NCT07764848CompletedNot Applicable

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

Instituto de Investigación Sanitaria Aragón1 site in 1 country34 target enrollmentStarted: February 5, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
34
Locations
1
Primary Endpoint
Pain Intensity (Numering Rating Scale)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Masking Description

No Masking

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Hybrid Physiotherapy Program

Experimental

Hybrid Physiotherapy Program consisted of Pain Neuroscience Education and Therapeutic Exercise

Intervention: Hybrid Physiotherapy Program (Other)

Outcomes

Primary Outcomes

Pain Intensity (Numering Rating Scale)

Time Frame: Baseline and Week 8

It is a numerical scale ranging from 1 to 10, where 1 represents the absence of pain and 10 represents the highest intensity.

Secondary Outcomes

  • 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)
  • Fear Avoidance Beliefs Questionnaire (FABQ)(Baseline and Week 8)
  • Clinical Global Impression Scale (CGI)(Baseline and Week 8)
  • Qualitative outcomes from focus groups(Week 8)

Investigators

Sponsor
Instituto de Investigación Sanitaria Aragón
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sandra Calvo Carrión

Phd. Clinical professor

Instituto de Investigación Sanitaria Aragón

Study Sites (1)

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