Clinical trial NCT04379765: Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
Official title: Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Spinal Stenosis
Keywords: Lumbar Spinal Stenosis
Rehabilitation
Surgery
Exercise
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

1. To be between 40-85 years old
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:

1. Having had lumbar surgery before
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

Primary outcomes:
measure: Clinical Evaluation VAS (visual analog scale) for pain assessment
timeFrame: 1st month
measure: Clinical Evaluation 2 functional status walking distance
timeFrame: 1st month
measure: Clinical Evaluation 3 Istanbul waist pain disability index
timeFrame: 1st month
measure: Clinical Evaluation 4 Nottingham Extended Life Profile
timeFrame: 1st month
Secondary outcomes:
measure: Clinical Evaluation 5
timeFrame: 12th month
measure: Clinical Evaluation 6
timeFrame: 12th month
measure: Clinical Evaluation 7
timeFrame: 12th month
measure: Clinical Evaluation 8
timeFrame: 12th month
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Science Health University Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
affiliation: Şişli Hamidiye Etfal Research and Training Hospital
name: Figen Yılmaz, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.