Skip to main content
OpenTrials
Completed

NCT Number: NCT04379765

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Science Health University Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • To be between 40-85 years old
  • Defining neurogenic claudication in patient anamnesis
  • Diagnosis of lumbar stenosis in MR and / or CT imaging
  • The duration of the symptom should be at least 4 weeks
  • Other causes of low back pain have been ruled out

Exclusion criteria

  • Having had lumbar surgery before
  • Physical therapy for lumbar spinal stenosis less than 3 months ago
  • Any lumbar injection has been applied before
  • Patients with inflammatory low back pain
  • Patients with spinal stenosis due to spondylolysis and / or spondylolisthesis
  • Patients with a history of trauma and suspected Vertebral fracture

Treatment and study plan

Exercise and physical therapy

Behavioral

Decompression operation

Other names: Surgery

Primary outcomes

  1. Clinical Evaluation VAS (visual analog scale) for pain assessment

    Time frame: 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.

  2. Clinical Evaluation 2 functional status walking distance

    Time frame: 1st month

    In patients with spinal stenosis, functional status walking distance will be used.

  3. Clinical Evaluation 3 Istanbul waist pain disability index

    Time frame: 1st month

    In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used.

  4. Clinical Evaluation 4 Nottingham Extended Life Profile

    Time frame: 1st month

    In patients with spinal stenosis, Nottingham Extended Life Profile will be used.

Secondary outcomes

  1. Clinical Evaluation 5

    Time frame: 12th month

    In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.

  2. Clinical Evaluation 6

    Time frame: 12th month

    In patients with spinal stenosis, functional status walking distance will be used in 3rd , 6th and 12th month.

  3. Clinical Evaluation 7

    Time frame: 12th month

    In patients with spinal stenosis, ILBDI (Istanbul waist pain disability index) form will be used in 3rd , 6th and 12th month.

  4. Clinical Evaluation 8

    Time frame: 12th month

    In patients with spinal stenosis, Nottingham Extended Life Profile will be used in 3rd , 6th and 12th month.

Sponsors and collaborators

Lead sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 7, 2020
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.