Clinical trial NCT06145620: Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery
Official title: Effects of a Prehabilitation Program Based on Therapeutic Exercise, Back Care Education and Neuroscience Pain Education in Patients Undergoing Lumbar Radiculopathy Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Lumbar Radiculopathy
Lead sponsor: Cardenal Herrera University
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Oswestry Disability Index (ODI)
timeFrame: 4 weeks
Secondary outcomes:
measure: SF-McGill Pain Questionnaire (SF-MGPQ)
timeFrame: 4 weeks
measure: Numerical Rating Scale (NRS)
timeFrame: 4 weeks
measure: EuroQol-5D (EQ-5D)
timeFrame: 4 weeks
measure: Fear avoidance beliefs questionnaire (FABQ)
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 4 weeks
measure: Pain catastrophizing scale (PCS)
timeFrame: 4 weeks
measure: Tampa scale for kinesiophobia (TSK-11SV)
timeFrame: 4 weeks
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Arguisuelas Martinez Maria Dolores
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.