Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery

Not yet recruiting

• Conditions: Outcomes; Symptom Duration; Lumbar Spine Surgery

• Registration Number: NCT07061067
• Lead Sponsor: Kafrelsheikh University

Brief Summary

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

Detailed Description

Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation.

The first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-02
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Study Start: 2025-07-15
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disability assessment	6 months postoperatively	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).

Secondary Outcome Measures

Name	Time	Method
Degree of patient satisfaction	6 months postoperatively	Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied).
Degree of pain	6 months postoperatively	Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents "no pain" while 10 represents "the worst pain imaginable").
Musculoskeletal conditions	6 months postoperatively	Global Perceived Effect (GPE) will be used to assess musculoskeletal conditions like neck pain. The GPE scale has seven steps (1=completely recovered, 2=much improved, 3=somewhat improved, 4=unchanged, 5=somewhat worse, 6=much worse, 7=worse than ever)

Trial Locations

Locations (1)

Kafrelsheikh University; 🇪🇬 Kafr Ash Shaykh, Kafrelsheikh, Egypt