Motor DeficitsNCT07413302
Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
An observational study of Motor Deficits and Lumbar Discectomy, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Deficits, Lumbar Discectomy, Muscle Weakness
- How many people
- 40 participants
- Where
- 3 sitesGreece
- Study dates
- 3 Jul 2024to Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients visiting the three recruitment hospitals, all located in North Greece.
Who may be able to join
- Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
- Age (years) > 17
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece3 sites, 3 recruiting
- Recruiting
General Hospital of Kavala
Kavala, 65500
Eva Kanelli, +302513501545, pk@kavalahospital.gr
Panagiotis Sarlis, MSc, MD
- Recruiting
Hippokration General Hospital
Thessaloniki, 54642
Dimitra Emmanouilidou, +302313312690, qre@ippokratio.gr
Ioannis Magras, Professor
- Recruiting
European Interbalkan Medical Center
Thessaloniki, 57001
Olymbia Semoglou, +302310400342, scientific.director@interbalkan-hosp.gr
Alkinoos Athanasiou
About this study
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.
Read the 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.
- Keywords
- microdiscectomy, lumbar disc herniation, motor deficit, lower limb paresis, prognostic factors microdiscectomy, disc herniation outcome
- Medical subject headings
- Neurologic Manifestations, Muscle Weakness, Paresis, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Perioperative
Duration of paresis before surgical treatment
Time between the initiation of paresis and surgical treatment measured in days
Measured: Baseline
Secondary outcomes (8)
Age
The age of participant as measured in years
Measured: 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.
Measured: Baseline
Diabetes Melitus
Participant is diagnosed with diabetes melitus (yes/no)
Measured: Baseline
Hernia location
Categorisation of hernia location based on Magnetic Resonance Imaging (MRI) to a) central, b) subarticular, c) foraminal, and d) extra-foraminal.
Measured: Baseline
Hernia morphology
Hernia morphology will be categorised based on radiology images to a) central, b) extrusion and c) sequestation.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start3 Jul 2024
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor DeficitsStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Hippocration General Hospital, General Hospital of Kavala, European Interbalkan Medical Center
- Responsible party
- Sponsor
- Investigators
- Panagiotis Sarlis, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413302
- Sponsor's protocol ID
- 292/2024
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Preoperative Factors Influencing the Outcome of Motor Deficits in Patients Undergoing Lumbar Microdiskectomy
- ClinicalTrials.gov ID
- NCT07413302
- Acronym / sponsor ID
- 292/2024
- Keywords
- microdiscectomy, lumbar disc herniation, motor deficit, lower limb paresis, prognostic factors microdiscectomy, disc herniation outcome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Hippocration General Hospital, General Hospital of Kavala, European Interbalkan Medical Center
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the three recruitment hospitals, all located in North Greece.
Key inclusion criteria (2 listed)
- Patients suffering from lower limb paresis (motor deficit) caused by lumbar disk herniation undergoing a single-level microdiskectomy
- Age (years) > 17
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Duration of paresis before surgical treatment
Time frame: Baseline
Time between the initiation of paresis and surgical treatment measured in days
8 secondary outcomes
Age
Time frame: Baseline
Obesity
Time frame: Baseline
Diabetes Melitus
Time frame: Baseline
Hernia location
Time frame: Baseline
Hernia morphology
Time frame: Baseline
Level of Pain
Time frame: Perioperative
Functionality
Time frame: Perioperative
Quality of life assessment
Time frame: Perioperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Motor Deficits
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
Recruiting
Cervical tsDCS on Stroke Patients
Functional Recovery, Motor Rehabilitation
Not yet recruiting
Cognitive-Motor Training With the DextEgg in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
Enrolling by invitation
Treatment of Cognitive and Sensorimotor Deficits in Parkinson's Disease With High Definition Transcranial Direct Current Stimulation
PARKINSON DISEASE (Disorder)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Panagiotis Sarlis principal investigator
Aristotle University Of Thessaloniki
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motor Deficits and Lumbar Discectomy, run by Aristotle University Of Thessaloniki at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Panagiotis Sarlis (+302513501449, psarlis@gapps.auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Strength (time frame: Perioperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.