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

Completed

• Conditions: Lumbar Spinal Stenosis
• Interventions: Behavioral: Exercise and physical therapy

• Registration Number: NCT04379765
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-07
• Primary Completion: 2023-10-15
• Study Completion: 2023-10-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-23
• Last Update Posted: 2023-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Grup 1: Exercise and physical therapy programme	Exercise and physical therapy	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.

Primary Outcome Measures

Name	Time	Method
Clinical Evaluation 3 Istanbul waist pain disability index	1st month	In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
Clinical Evaluation 4 Nottingham Extended Life Profile	1st month	In patients with spinal stenosis, Nottingham Extended Life Profile will be used.
Clinical Evaluation VAS (visual analog scale) for pain assessment	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.
Clinical Evaluation 2 functional status walking distance	1st month	In patients with spinal stenosis, functional status walking distance will be used.

Secondary Outcome Measures

Name	Time	Method
Clinical Evaluation 5	12th month	In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.
Clinical Evaluation 6	12th month	In patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.
Clinical Evaluation 8	12th month	In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.
Clinical Evaluation 7	12th month	In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.

Trial Locations

Locations (1)

Science Health University Şişli Hamidiye Etfal Training and Research Hospital; 🇹🇷 İstanbul, Turkey