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Clinical Trials/NCT06145620
NCT06145620
Not Yet Recruiting
N/A

Effects of a Prehabilitation Program Based on Therapeutic Exercise, Back Care Education and Neuroscience Pain Education in Patients Undergoing Lumbar Radiculopathy Surgery

Cardenal Herrera University1 site in 1 country100 target enrollmentApril 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Lumbar Radiculopathy
Sponsor
Cardenal Herrera University
Enrollment
100
Locations
1
Primary Endpoint
Oswestry Disability Index (ODI)
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of the following study is to analyze the effects of a prehabilitation program based on therapeutic exercise, back care education and pain neuroscience education through the visualization of videos, compared to standardized written therapeutic exercise in patients undergoing lumbar radiculopathy surgery.

Detailed Description

So far, there are no previous studies that analyze the effects of a prehabilitation program including therapeutic exercise, back care education and pain neuroscience education through the visualization of videos in patients undergoing lumbar radiculopathy surgery. This is a multicenter randomized clinical trial aimed at analyzing the effects of a 4 weeks prehabilitation program based on video visualization versus the performance of standardized written exercises in patients undergoing lumbar radiculopathy surgery.

Registry
clinicaltrials.gov
Start Date
April 2025
End Date
April 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cardenal Herrera University
Responsible Party
Principal Investigator
Principal Investigator

ARGUISUELAS MARTINEZ MARÍA DOLORES

Professor

Cardenal Herrera University

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 years or older, diagnosed with lumbar radiculopathy, and scheduled for surgery. The symptoms will be predominantly leg pain with or without neurological deficit, with surgical decompression justified.

Exclusion Criteria

  • Patients currently receiving any other non-pharmacological treatment or physical therapy for the management of lumbar radiculopathy.
  • Proposed for surgery with instrumentation (e.g., spinal fusion, arthrodesis).
  • Suffering from a chronic pain-related condition (e.g., fibromyalgia, chronic fatigue syndrome).
  • Symptoms of spinal cord compression.
  • Diagnosed with a malignant tumor.
  • Mental illness.
  • Previously undergone spinal surgery.
  • No access to any internet-enabled device.

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

Time Frame: 4 weeks

Disability score (0-100). Higher score indicates higher disability.

Secondary Outcomes

  • Pain catastrophizing scale (PCS)(4 weeks)
  • SF-McGill Pain Questionnaire (SF-MGPQ)(4 weeks)
  • International Physical Activity Questionnaire (IPAQ)(4 weeks)
  • Numerical Rating Scale (NRS)(4 weeks)
  • EuroQol-5D (EQ-5D)(4 weeks)
  • Hospital Anxiety and Depression Scale (HADS)(4 weeks)
  • Tampa scale for kinesiophobia (TSK-11SV)(4 weeks)
  • Fear avoidance beliefs questionnaire (FABQ)(4 weeks)

Study Sites (1)

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