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

NCT04379765 | Completed

• 1 other identifier: 2373
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Keywords

Lumbar Spinal Stenosis; Rehabilitation; Surgery; Exercise

Outcome Measures

Primary Outcomes (4)

• 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

• Clinical Evaluation 2 functional status walking distance

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

  1st month

• 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

• Clinical Evaluation 4 Nottingham Extended Life Profile

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

  1st month

Secondary Outcomes (4)

• Clinical Evaluation 5

  12th month

• Clinical Evaluation 6

  12th month

• Clinical Evaluation 7

  12th month

• Clinical Evaluation 8

  12th month

Study Arms (2)

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

Grup 2: Surgical procedure programme

30 patients with lumbar spinal stenosis underwent decompression operation of the relevant level.

Interventions

Exercise and physical therapy BEHAVIORAL

Decompression operation

Also known as: Surgery

Grup 1: Exercise and physical therapy programme

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sisli Hamidiye Etfal Training and Research Hospital: lead

Study Sites (1)

Science Health University Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, 34100, Turkey (Türkiye)

Location

Related 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):239. doi: 10.1186/s13018-018-0947-2.

  PMID: 30227869 RESULT

MeSH Terms

Conditions

Spinal Stenosis; Motor Activity

Interventions

Exercise; Physical Therapy Modalities; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation

Study Officials

• Figen Yılmaz, Prof. Dr.

  Şişli Hamidiye Etfal Research and Training Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor in Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: May 7, 2020
• Study Start: March 1, 2020
• Primary Completion: October 15, 2023
• Study Completion: October 30, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Locations

TU (1)