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NCT Number: NCT06145620

Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

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.

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Key information

Conditions

Lumbar Radiculopathy Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Radiculopathy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arguisuelas Martinez Maria Dolores

Valencia, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Physiotherapy

Other

The intervention involves the visualization of different videos explaining the performance of lumbar strengthening exercises, measures for back care, and neuroscience pain education.

Primary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: 4 weeks

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

Secondary outcomes

  1. SF-McGill Pain Questionnaire (SF-MGPQ)

    Time frame: 4 weeks

    Pain score (0-45). Higher score indicates higher pain level

  2. Numerical Rating Scale (NRS)

    Time frame: 4 weeks

    Pain score 0-10. Higher score indicates higher pain intensity.

  3. EuroQol-5D (EQ-5D)

    Time frame: 4 weeks

    Quality of life score (-0.5 to 1).Higher score indicates higher health-related quality of life

  4. Fear avoidance beliefs questionnaire (FABQ)

    Time frame: 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

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: 4 weeks

    Anxiety and depression score (0-21). Hhigher score indicates greater symptoms of anxiety and depression.

  6. Pain catastrophizing scale (PCS)

    Time frame: 4 weeks

    pain catastrophizing score (0-52). Higher scores indicate greater pain catastrophizing

  7. Tampa scale for kinesiophobia (TSK-11SV)

    Time frame: 4 weeks

    kinesiophobia score (11-44). Higher scores indicate greater kinesiophobia

  8. International Physical Activity Questionnaire (IPAQ)

    Time frame: 4 weeks

    Physical activity level (MET minutes a week). Higher scores indicate higher physical activity level

Study contacts

Contact information is provided by the study sponsor or research team.

María Dolores Arguisuelas

CONTACT

[email protected]

96 136 90 00

María Dolores Arguisuelas

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cardenal Herrera University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 24, 2023
Registry last updated
Feb 12, 2025

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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