Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis

Lumbar Spinal Stenosis Clinical Trial

Official title:

Long-term Follow-up of Conservative and Surgical Treatment Results of Patients With Lumbar Spinal Stenosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04379765
• Other study ID #: 2373
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: October 30, 2023

Study information

• Verified date: November 2023
• Source: Sisli Hamidiye Etfal Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: October 15, 2023
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Lumbar Spinal Stenosis
• Spinal Stenosis

Intervention

Behavioral:
• Exercise and physical therapy
Decompression operation

Locations

Country	Name	City	State
Turkey	Science Health University Sisli Hamidiye Etfal Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Evaluation VAS (visual analog scale) for pain assessment	Clinical evaluation will be done by the same physician. In patients with spinal stenosis, VAS (visual analog scale) for pain assessment will be used.	1st month
Primary	Clinical Evaluation 2 functional status walking distance	In patients with spinal stenosis, functional status walking distance will be used.	1st month
Primary	Clinical Evaluation 3 Istanbul waist pain disability index	In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.	1st month
Primary	Clinical Evaluation 4 Nottingham Extended Life Profile	In patients with spinal stenosis, Nottingham Extended Life Profile will be used.	1st month
Secondary	Clinical Evaluation 5	In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.	12th month
Secondary	Clinical Evaluation 6	In patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.	12th month
Secondary	Clinical Evaluation 7	In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.	12th month
Secondary	Clinical Evaluation 8	In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.	12th month