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NCT Number: NCT07061067

Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery

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

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Key information

Conditions

Symptom Duration Lumbar Spine Surgery Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location status: Recruiting

Location contact

Ahmed A Zahra, MD

PRINCIPAL_INVESTIGATOR

Ayman M Basha, MD

CONTACT

[email protected]

00201063037278

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Disability assessment

    Time frame: 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 outcomes

  1. Degree of pain

    Time frame: 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").

  2. Musculoskeletal conditions

    Time frame: 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)

  3. Degree of patient satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Ayman M Basha, MD

CONTACT

[email protected]

00201063037278

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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