Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery

Lumbar Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06145620
• Other study ID #: CEEI23/459
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2025

Study information

• Verified date: November 2023
• Source: Cardenal Herrera University
• Contact: María Dolores Arguisuelas
• Phone: 96 136 90 00
• Email: doloresarguisuelas[@]uchceu.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

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.

Locations

Country	Name	City	State
Spain	Arguisuelas Martinez Maria Dolores	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Cardenal Herrera University

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oswestry Disability Index (ODI)	Disability score (0-100). Higher score indicates higher disability.	4 weeks
Secondary	SF-McGill Pain Questionnaire (SF-MGPQ)	Pain score (0-45). Higher score indicates higher pain level	4 weeks
Secondary	Numerical Rating Scale (NRS)	Pain score 0-10. Higher score indicates higher pain intensity.	4 weeks
Secondary	EuroQol-5D (EQ-5D)	Quality of life score (-0.5 to 1).Higher score indicates higher health-related quality of life	4 weeks
Secondary	Fear avoidance beliefs questionnaire (FABQ)	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	4 weeks
Secondary	Hospital Anxiety and Depression Scale (HADS)	Anxiety and depression score (0-21). Hhigher score indicates greater symptoms of anxiety and depression.	4 weeks
Secondary	Pain catastrophizing scale (PCS)	pain catastrophizing score (0-52). Higher scores indicate greater pain catastrophizing	4 weeks
Secondary	Tampa scale for kinesiophobia (TSK-11SV)	kinesiophobia score (11-44). Higher scores indicate greater kinesiophobia	4 weeks
Secondary	International Physical Activity Questionnaire (IPAQ)	Physical activity level (MET minutes a week). Higher scores indicate higher physical activity level	4 weeks