Health TrialsbyHealthPanel

Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery

ConditionsSymptom DurationOutcomesLumbar Spine Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKafrelsheikh University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Previous spinal surgery.

Vascular claudication.

Comorbid pathology affecting walking ability.

Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Lumbar Spine Surgery

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Study group1 intervention

Trial outcomes

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).

Time frame
6 months postoperatively

Secondary outcomes

1

Degree of pain

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").

Time frame
6 months postoperatively
2

Musculoskeletal conditions

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)

Time frame
6 months postoperatively
3

Degree of patient satisfaction

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).

Time frame
6 months postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kafrelsheikh University

Lead sponsor

Source ClinicalTrials.gov
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