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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04379765
Enrollment
40
Registered
2020-05-07
Start date
2020-03-01
Completion date
2023-10-30
Last updated
2023-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal Stenosis, Rehabilitation, Surgery, Exercise

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.

Interventions

BEHAVIORALExercise and physical therapy

Decompression operation

Sponsors

Sisli Hamidiye Etfal Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Clinical Evaluation 3 Istanbul waist pain disability index1st monthIn patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.
Clinical Evaluation VAS (visual analog scale) for pain assessment1st monthClinical 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 distance1st monthIn patients with spinal stenosis, functional status walking distance will be used.
Clinical Evaluation 4 Nottingham Extended Life Profile1st monthIn patients with spinal stenosis, Nottingham Extended Life Profile will be used.

Secondary

MeasureTime frameDescription
Clinical Evaluation 612th monthIn patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.
Clinical Evaluation 512th monthIn patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.
Clinical Evaluation 712th monthIn patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.
Clinical Evaluation 812th monthIn patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026