Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

Not Applicable

Not yet recruiting

• Conditions: Lumbar Radiculopathy
• Interventions: Other: Physiotherapy

• Registration Number: NCT06145620
• Lead Sponsor: Cardenal Herrera University

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.

Study Timeline

• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Study Start: 2025-04
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standarized written exercise group	Physiotherapy	-
Therapeutic exercise, back care and pain neuroscience education group	Physiotherapy	-

Primary Outcome Measures

Name	Time	Method
Oswestry Disability Index (ODI)	4 weeks	Disability score (0-100). Higher score indicates higher disability.

Secondary Outcome Measures

Name	Time	Method
SF-McGill Pain Questionnaire (SF-MGPQ)	4 weeks	Pain score (0-45). Higher score indicates higher pain level
Pain catastrophizing scale (PCS)	4 weeks	pain catastrophizing score (0-52). Higher scores indicate greater pain catastrophizing
International Physical Activity Questionnaire (IPAQ)	4 weeks	Physical activity level (MET minutes a week). Higher scores indicate higher physical activity level
Numerical Rating Scale (NRS)	4 weeks	Pain score 0-10. Higher score indicates higher pain intensity.
EuroQol-5D (EQ-5D)	4 weeks	Quality of life score (-0.5 to 1).Higher score indicates higher health-related quality of life
Hospital Anxiety and Depression Scale (HADS)	4 weeks	Anxiety and depression score (0-21). Hhigher score indicates greater symptoms of anxiety and depression.
Tampa scale for kinesiophobia (TSK-11SV)	4 weeks	kinesiophobia score (11-44). Higher scores indicate greater kinesiophobia
Fear avoidance beliefs questionnaire (FABQ)	4 weeks	FABQ-Work subscale (ranging from 0 to 42) and FABQ-Physical Activity subscale (ranging from 0 to 24). Higher score indicates more signs of fear avoidance

Trial Locations

Locations (1)

Arguisuelas Martinez Maria Dolores; 🇪🇸 Valencia, Spain