- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04379765
Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Aylin Ayyıldız, Doctor
- Phone Number: +90 538 503 3693
- Email: aylin.mrt93@gmail.com
Study Contact Backup
- Name: Figen Yılmaz, Prof. Dr.
- Phone Number: +90 532 300 7140
- Email: figenyilmaz@yahoo.com
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
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
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In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
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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
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In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.
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12th month
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Collaborators and Investigators
Investigators
- Principal Investigator: Figen Yılmaz, Prof. Dr., Sisli Hamidiye Etfal Research and Training Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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