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Not yet recruiting NCT06145620

Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

No phase Interventional Lumbar Radiculopathy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physiotherapy.
Who it may be relevant to
Registry conditions: Lumbar Radiculopathy. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Oswestry Disability Index (ODI) [Time frame: 4 weeks]
Secondary outcome measures (8)
  • SF-McGill Pain Questionnaire (SF-MGPQ) [Time frame: 4 weeks]
  • Numerical Rating Scale (NRS) [Time frame: 4 weeks]
  • EuroQol-5D (EQ-5D) [Time frame: 4 weeks]
  • Fear avoidance beliefs questionnaire (FABQ) [Time frame: 4 weeks]
  • Hospital Anxiety and Depression Scale (HADS) [Time frame: 4 weeks]
  • Pain catastrophizing scale (PCS) [Time frame: 4 weeks]
  • Tampa scale for kinesiophobia (TSK-11SV) [Time frame: 4 weeks]
  • International Physical Activity Questionnaire (IPAQ) [Time frame: 4 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Arguisuelas Martinez Maria Dolores — Valencia

Publications

  • Lindback Y, Tropp H, Enthoven P, Abbott A, Oberg B. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial. Spine J. 2018 Aug;18(8):1347-1355. doi: 10.1016/j.spinee.2017.12.009. Epub 2017 Dec 15. PMID 29253630
  • Louw A, Butler DS, Diener I, Puentedura EJ. Development of a preoperative neuroscience educational program for patients with lumbar radiculopathy. Am J Phys Med Rehabil. 2013 May;92(5):446-52. doi: 10.1097/PHM.0b013e3182876aa4. PMID 23478459
  • Goudman L, Huysmans E, Ickmans K, Nijs J, Moens M, Putman K, Buyl R, Louw A, Logghe T, Coppieters I. A Modern Pain Neuroscience Approach in Patients Undergoing Surgery for Lumbar Radiculopathy: A Clinical Perspective. Phys Ther. 2019 Jul 1;99(7):933-945. doi: 10.1093/ptj/pzz053. PMID 30921465

Identifiers

NCT: NCT06145620 · CEEI23/459

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗