Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
November 23, 2023 updated by: Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment.
Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients between 40-85 years old who are hospitalized and treated with the diagnosis of LSS in Physical Medicine and rehabilitation, Orthopedics and Neurosurgery Clinics will be included in the study. The diagnosis of LSS will be made by MR and / or CT and neurogenic claudication history.
Total of 60 patients with a diagnosis of spinal stenosis is planned for 30 patients, with physical therapy modeling and exercise, and 30 patients with surgical treatment, and the duration of the study is considered to be 24 months. Patients will be evaluated by the same physician 5 times, before early primary treatment, 1st month, 3rd month, 6th month and 12th month after treatment.
Clinical evaluation will be done by the same physician. In patients with spinal stenosis, pain (movement, rest, night) VAS, functional status walking distance and ILBDI (Istanbul waist pain disability index) inquiry form, Nottingham Extended Life Profile will be used.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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İstanbul, Turkey, 34100
- Science Health University Şişli Hamidiye Etfal Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 81 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
It is planned to take 60 patients with a diagnosis of spinal stenosis to perform physical therapy models and exercise for 30 patients and surgical treatment for 30 patients.
Patients between the ages of 40-85 will be admitted and no difference will be made in terms of gender.
The child patient will not be included in the study.
Description
Inclusion Criteria:
- To be between 40-85 years old
- Defining neurogenic claudication in patient anamnesis
- Diagnosis of lumbar stenosis in MR and / or CT imaging
- The duration of the symptom should be at least 4 weeks
- Other causes of low back pain have been ruled out
Exclusion Criteria:
- Having had lumbar surgery before
- Physical therapy for lumbar spinal stenosis less than 3 months ago
- Any lumbar injection has been applied before
- Patients with inflammatory low back pain
- Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
- Patients with a history of trauma and suspected Vertebral fracture
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Grup 1: Exercise and physical therapy programme
30 patients with lumbar spinal stenosis will receive hot pack, transcutaneous electrical nerve stimulation and deep warming as a physical therapy modality , and lumber flexion and strengthening exercises were performed for 7 times/week for 3 weeks.
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Decompression operation
Other Names:
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Grup 2: Surgical procedure programme
30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Evaluation VAS (visual analog scale) for pain assessment
Time Frame: 1st month
|
Clinical evaluation will be done by the same physician.
In patients with spinal stenosis, VAS (visual analog scale) for pain assessment will be used.
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1st month
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Clinical Evaluation 2 functional status walking distance
Time Frame: 1st month
|
In patients with spinal stenosis, functional status walking distance will be used.
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1st month
|
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Clinical Evaluation 3 Istanbul waist pain disability index
Time Frame: 1st month
|
In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
|
1st month
|
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Clinical Evaluation 4 Nottingham Extended Life Profile
Time Frame: 1st month
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In patients with spinal stenosis, Nottingham Extended Life Profile will be used.
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1st month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Evaluation 5
Time Frame: 12th month
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In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.
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12th month
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Clinical Evaluation 6
Time Frame: 12th month
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In patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.
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12th month
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Clinical Evaluation 7
Time Frame: 12th month
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In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.
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12th month
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Clinical Evaluation 8
Time Frame: 12th month
|
In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.
|
12th month
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Figen Yılmaz, Prof. Dr., Şişli Hamidiye Etfal Research and Training Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
October 15, 2023
Study Completion (Actual)
October 30, 2023
Study Registration Dates
First Submitted
March 19, 2020
First Submitted That Met QC Criteria
May 4, 2020
First Posted (Actual)
May 7, 2020
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 23, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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