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

November 23, 2023 updated by: Aylin Ayyıldız, Sisli Hamidiye Etfal Training and Research Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34100
        • Science Health University Şişli Hamidiye Etfal Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Grup 1: Exercise and physical therapy programme
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.
Behavioral: Exercise and physical therapy
Decompression operation
Other Names:
  • Surgery
Grup 2: Surgical procedure programme
30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1st month
Clinical Evaluation 2 functional status walking distance
Time Frame: 1st month
In patients with spinal stenosis, functional status walking distance will be used.
1st month
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.
1st month
Clinical Evaluation 4 Nottingham Extended Life Profile
Time Frame: 1st month
In patients with spinal stenosis, Nottingham Extended Life Profile will be used.
1st month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Evaluation 5
Time Frame: 12th month
In patients with spinal stenosis, VAS will be used in 3rd , 6th and 12th month.
12th month
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.
12th month
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.
12th month
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.
12th month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Investigators

  • Principal Investigator: Figen Yılmaz, Prof. Dr., Şişli Hamidiye Etfal Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Actual)

October 15, 2023

Study Completion (Actual)

October 30, 2023

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

May 4, 2020

First Posted (Actual)

May 7, 2020

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 23, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2373

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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