Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy

Lumbar disc herniations may result in lower limb weakness. In such cases, there is a strong indication for surgical intervention through microdiscectomy. This clinical study aims to investigate preoperative factors that may influence the postoperative outcomes of patients undergoing this procedure.

Study Overview

• Status: Recruiting
• Conditions: Muscle Weakness; Paresis; Lumbar Disc Herniation; Motor Deficits; Lumbar Discectomy

Detailed Description

Background: Motor deficits owing to neural compression caused by lumbar disc herniation are a common problem encountered in spine surgery. Microdiscectomy is considered the preferred procedure for the treatment of limb paresis related to a herniated disc. Nevertheless, there is a restricted number of clinical studies in the literature investigating the role of preoperative factors that could influence the postoperative outcome in these patients.

Aim: To investigate the prognostic factors determining the outcome in patients with lower limb paresis caused by a herniated lumbar disc subjected to microdiscektomy.

Study type: Primary clinical research, observational prognostic study. Materials: Patients suffering from a motor deficit due to lumbar disc herniation to undergo lumbar microdiscectomy in three neurosurgical departments.

Protocol: Prospective multicenter study. This research will discover the prognostic value of two primary and five secondary preoperative factors. Primary factors: a) the severity of paresis, b) the duration of paresis. Secondary factors: a) age, b) body mass index, c) diabetes mellitus, d) anatomic location of the herniated disc, e) morphology of the herniated disc.

Outcomes: The key evaluation criterion is the muscle strength of the most severely affected lower limb muscle according to the six-point (0-5) Medical Research Counsil (MRC) Scale for Muscle Strength. After the comparison between the postoperative and preoperative muscle strength, the outcome of paresis will be recorded as: a) full recovery, b) partial recovery or c) no recovery.

Sample size: Forty (40) patients.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Panagiotis Sarlis; Phone Number: +302513501449; Email: psarlis@gapps.auth.gr

Study Locations

• Greece
  • Kavala, Greece, 65500
    • Recruiting
    • General Hospital of Kavala
    • Contact: Eva Kanelli; Phone Number: +302513501545; Email: pk@kavalahospital.gr
    • Principal Investigator: Panagiotis Sarlis, MSc, MD
    • Sub-Investigator: Stavros Stamatiou
    • Sub-Investigator: Georgios Kalostos
  • Thessaloniki, Greece, 57001
    • Recruiting
    • European Interbalkan Medical Center
    • Contact: Olymbia Semoglou; Phone Number: +302310400342; Email: scientific.director@interbalkan-hosp.gr
    • Principal Investigator: Alkinoos Athanasiou
    • Sub-Investigator: Georgios Psychidis
    • Sub-Investigator: Georgios Antonoglou
  • Thessaloniki, Greece, 54642
    • Recruiting
    • Hippokration General Hospital
    • Contact: Dimitra Emmanouilidou; Phone Number: +302313312690; Email: qre@ippokratio.gr
    • Principal Investigator: Ioannis Magras, Professor
    • Sub-Investigator: Parmenion Tsitsopoulos, Professor
    • Sub-Investigator: Elias Antoniades
    • Sub-Investigator: Emmanouil Kenanoglou
    • Sub-Investigator: Panagiotis Kartsidis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients visiting the three recruitment hospitals, all located in North Greece.

Description

Inclusion Criteria:

• Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
• Age (years) > 17

Exclusion Criteria:

• Age (years) < 18
• Medical history of lumbar spine surgery
• Absence of limb paresis
• Motor deficit caused by other than disk herniation aetiologies
• Reoperation within 6 months after microdiskectomy
• Microdiskectomy at more than one level
• Cauda equina syndrome
• Peripheral neuropathy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with limb paresis due to lumbar disk herniation undergoing microdiskectomy; Patients suffering from motor deficit because of lumbar disk herniation scheduled to undergo single-level microdiskectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength	The strength of lower main muscles will be assessed and will be rated according to the Medical Research Council Scale for Muscle Strength. The scale takes values between 0 and 5, with 5 being the best possible (healthy).	Perioperative
Duration of paresis before surgical treatment	Time between the initiation of paresis and surgical treatment measured in days	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	The age of participant as measured in years	Baseline
Obesity	Body Mass Index (BMI) measured as the ratio between the mass measured in kilograms over the square of height measured in meters. There will be two groups of patients: a) with obesity and b) without obesity.	Baseline
Diabetes Melitus	Participant is diagnosed with diabetes melitus (yes/no)	Baseline
Hernia location	Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal.	Baseline
Hernia morphology	Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation.	Baseline
Level of Pain	The pain level of participants will be measured using the Numeric Rating Scale for Pain which ranges from 0 (no pain) to 10 (worst pain imaginable).	Perioperative
Functionality	The functionality of participants will be measured using the Oswestry Disability Index (ODI) which consists of 10 questions using a 5-level Likert scale with 0 being the best.	Perioperative
Quality of life assessment	This outcome will be measured using the EQ-5D-5L questionnaire. It is using 5-Level Likert scale, with 0 being the best. Also, it includes a self-report of health status using a 0 to 100 scale, 100 being best.	Perioperative

Collaborators and Investigators

• Sponsor: Aristotle University Of Thessaloniki
• Collaborators: Hippocration General Hospital; European Interbalkan Medical Center; General Hospital of Kavala
• Investigators: Principal Investigator: Panagiotis Sarlis, Aristotle University Of Thessaloniki

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: lumbar disc herniation; microdiscectomy; motor deficit; lower limb paresis; prognostic factors microdiscectomy; disc herniation outcome
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathologic Processes; Pathological Conditions, Anatomical; Spinal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations; Intervertebral Disc Displacement; Muscle Weakness; Paresis
• Other Study ID Numbers: 292/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No