Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
NCT ID: NCT04379765
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2020-03-01
2023-10-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Exercise and physical therapy
Decompression operation
Grup 2: Surgical procedure programme
30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level.
No interventions assigned to this group
Interventions
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Exercise and physical therapy
Decompression operation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Defining neurogenic claudication in patient anamnesis
3. Diagnosis of lumbar stenosis in MR and / or CT imaging
4. The duration of the symptom should be at least 4 weeks
5. Other causes of low back pain have been ruled out
Exclusion Criteria
2. Physical therapy for lumbar spinal stenosis less than 3 months ago
3. Any lumbar injection has been applied before
4. Patients with inflammatory low back pain
5. Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
6. Patients with a history of trauma and suspected Vertebral fracture
40 Years
85 Years
ALL
No
Sponsors
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Sisli Hamidiye Etfal Training and Research Hospital
OTHER
Responsible Party
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Aylin Ayyıldız
Medical Doctor in Physical Medicine and Rehabilitation
Principal Investigators
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Figen Yılmaz, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Şişli Hamidiye Etfal Research and Training Hospital
Locations
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Science Health University Şişli Hamidiye Etfal Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Tsubosaka M, Kaneyama S, Yano T, Kasahara K, Kanemura A, Takabatake M, Hirata H, Sumi M. The factors of deterioration in long-term clinical course of lumbar spinal canal stenosis after successful conservative treatment. J Orthop Surg Res. 2018 Sep 18;13(1):239. doi: 10.1186/s13018-018-0947-2.
Other Identifiers
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2373
Identifier Type: -
Identifier Source: org_study_id