Symptom DurationNCT07061067
Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery
An observational study of Symptom Duration and Outcomes, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Symptom Duration, Outcomes, Lumbar Spine Surgery
- What is being tested?
- Lumbar Spine Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Jul 2025to 1 Jan 2026
- 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: 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.
Who may be able to join
- 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.
Who cannot join
- Previous spinal surgery.
- Vascular claudication.
- Comorbid pathology affecting walking ability.
- Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).
- Bony metastases.
- Unfit for general anaesthesia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 33516
Ayman M Basha, MD, 00201063037278, aymanbasha424@gmail.com
Ahmed A Zahra, MD
About this study
This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery.
Read the detailed description
Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation.
The first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.
- Conditions
- Symptom Duration, Outcomes, Lumbar Spine Surgery
- Being tested
- Lumbar Spine Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Spine SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Patients undergoing lumbar spine surgery Receives: Procedure: Lumbar Spine Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months postoperatively
Secondary outcomes (3)
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").
Measured: 6 months postoperatively
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)
Measured: 6 months postoperatively
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).
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start19 Jul 2025
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptom DurationStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayman Mohamed Basha, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061067
- Sponsor's protocol ID
- KFSIRB200-644
- Status last verified
- Jul 2025
- First submitted
- 2 Jul 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affection of Symptoms Duration on Outcomes of Lumbar Spine Surgery
- ClinicalTrials.gov ID
- NCT07061067
- Acronym / sponsor ID
- KFSIRB200-644
- Conditions
- Symptom Duration, Outcomes, Lumbar Spine Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 19 Jul 2025 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 11 Jul 2025 (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.
This study aims to evaluate the affection of symptoms duration on outcomes of lumbar spine surgery.
Detailed description
Lumbar spine surgery is a pivotal intervention for a variety of conditions affecting the lower back, such as degenerative disc disease, spinal stenosis, spondylolisthesis, and disc herniation.
The first line of treatment in lumbar spine is usually conservative. If conservative treatment fails to lead to an improvement in symptoms in 3 to 6 months, surgical treatment can be considered as an option for symptom relief. Invasive therapies are considered when neurogenic claudication is present with positive findings from diagnostic imaging. Surgery has been shown to provide better outcomes for at least 4 years in terms of disability and pain with a narrowing of the benefits over time compared with conservative treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Procedure: Lumbar Spine SurgeryPatients undergoing lumbar spine surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Previous spinal surgery.
- Vascular claudication.
- Comorbid pathology affecting walking ability.
- Severe comorbidities that may impact surgery outcomes (e.g., uncontrolled diabetes, cardiovascular disease).
- Bony metastases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar Spine SurgeryPatients 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. | Procedure or surgery | Study group |
Primary outcome
Disability assessment
Time frame: 6 months postoperatively
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).
3 secondary outcomes
Degree of pain
Time frame: 6 months postoperatively
Musculoskeletal conditions
Time frame: 6 months postoperatively
Degree of patient satisfaction
Time frame: 6 months postoperatively
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 22 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Symptom Duration and Outcomes, run by Kafrelsheikh University at 1 site in Egypt.
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 4 inclusion and 6 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 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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 Ayman M Basha, MD (00201063037278, aymanbasha424@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability assessment (time frame: 6 months postoperatively). 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 22 Jul 2025.