Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery

NCT07061067 | Recruiting

• 1 other identifier: KFSIRB200-644
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery.

Conditions

Symptom Duration; Outcomes; Lumbar Spine Surgery

Outcome Measures

Primary Outcomes (1)

• Disability assessment

  Disability assessment will be done by the Oswestry Disability Index (ODI). ODI is a pain-related disability score ranging from 0 (no impairment) to 100 (bedbound).

  6 months postoperatively

Secondary Outcomes (3)

• Degree of pain

  6 months postoperatively

• Musculoskeletal conditions

  6 months postoperatively

• Degree of patient satisfaction

  6 months postoperatively

Study Arms (1)

Study group

Patients undergoing lumbar spine surgery

Procedure: Lumbar Spine Surgery

Interventions

Lumbar Spine Surgery PROCEDURE

Patients undergoing lumbar spine surgery Presenting symptoms include lumbar back pain, lumbar radiculopathy, neurogenic claudication, lower-extremity weakness, bowel or bladder symptoms, and duration of symptoms.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This prospective study will be carried out on 60 patients undergoing lumbar spine surgery admitted in KafrElsheikh University Hospitals over a period of 6 months starting from approval of the Medical Sciences Ethics Committee of KafrElsheikh Faculty of Medicine and all the included patients will provide written informed consent.

You may qualify if:

• Age ≥18 years old.
• Both sexes.
• Patients undergoing lumbar spine surgery
• Presenting symptoms include lumbar back pain, lumbar radiculopathy, neurogenic claudication, lower-extremity weakness, bowel or bladder symptoms, and duration of symptoms.

You may not qualify if:

• Previous spinal surgery.
• Vascular claudication.
• Comorbid pathology affecting walking ability.
• Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).
• Bony metastases.
• Unfit for general anaesthesia.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

RECRUITING

Central Study Contacts

Ayman M Basha, MD

CONTACT

00201063037278; aymanbasha424@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurosurgery, Faculty of Medicine, KafrElsheikh University, KafrElsheikh, Egypt

Study Record Dates

• First Submitted: July 2, 2025
• First Posted: July 11, 2025
• Study Start: July 19, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)