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NCT Number: NCT07413302

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.

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Key information

Conditions

Motor Deficits Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Disc Herniation Lumbar Discectomy Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Paresis Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General Hospital of Kavala, Kavala, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Muscle Strength

    Time frame: Perioperative

    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).

  2. Duration of paresis before surgical treatment

    Time frame: Baseline

    Time between the initiation of paresis and surgical treatment measured in days

Secondary outcomes

  1. Age

    Time frame: Baseline

    The age of participant as measured in years

  2. Obesity

    Time frame: Baseline

    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.

  3. Diabetes Melitus

    Time frame: Baseline

    Participant is diagnosed with diabetes melitus (yes/no)

  4. Hernia location

    Time frame: Baseline

    Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal.

  5. Hernia morphology

    Time frame: Baseline

    Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation.

  6. Level of Pain

    Time frame: Perioperative

    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).

  7. Functionality

    Time frame: Perioperative

    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.

  8. Quality of life assessment

    Time frame: Perioperative

    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.

Study contacts

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

Panagiotis Sarlis

CONTACT

[email protected]

+302513501449

Sponsors and collaborators

Lead sponsor

Aristotle University Of Thessaloniki

Other

Collaborators

  • European Interbalkan Medical Center
  • General Hospital of Kavala
  • Hippocration General Hospital

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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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