Lumbar Discectomy, Lumbar Disc Herniation, Motor Deficits, Muscle Weakness, Paresis
Conditions
Keywords
microdiscectomy, lumbar disc herniation, motor deficit, lower limb paresis, prognostic factors microdiscectomy, disc herniation outcome
Brief summary
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.
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.
Interventions
None listed
Sponsors
Aristotle University Of Thessaloniki
Hippocration General Hospital
General Hospital of Kavala
European Interbalkan Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Strength | 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). |
| Duration of paresis before surgical treatment | Baseline | Time between the initiation of paresis and surgical treatment measured in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age | Baseline | The age of participant as measured in years |
| Obesity | 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. |
| Diabetes Melitus | Baseline | Participant is diagnosed with diabetes melitus (yes/no) |
| Hernia location | Baseline | Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal. |
| Hernia morphology | Baseline | Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation. |
| Level of Pain | 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). |
| Functionality | 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. |
| Quality of life assessment | 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. |
Countries
Greece
Contacts
CONTACTPanagiotis Sarlis
PRINCIPAL_INVESTIGATORPanagiotis Sarlis
Aristotle University Of Thessaloniki
Outcome results
None listed