Investigating the effective causes in the improvement of pain and disability caused by low back pain, as well as the improvement of imaging findings after lumbar spine surgery, which includes the first sacral vertebra, in patients with lumbar canal stenosis

Phase 2

Recruiting

• Conditions: M99.53; umbar canal stenosis.; Intervertebral disc stenosis of neural canal of lumbar region

• Registration Number: IRCT20110829007441N4
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 7 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Patient consent to participate in the research project
Age> 18 years
Confirmation of the diagnosis of lumbar spinal stenosis based on clinical examinations and imaging findings by neurosurgeon and spine and radiologist colleagues.
Chronic low back pain for more than six months, persistent low back pain with or without shooting pains to the upper leg, neurogenic claudication, focal tenderness above the lumbar vertebral joint, and hyperextension pain leading to sensory or motor neurological deficit or inability to perform daily tasks
Lumbar canal stenosis patients with indications for lumbosacral spine fixation and decompression surgery including: radicular syndrome, failure to respond to non-surgical treatments (rest, medical treatment, physical therapy), foraminal and lateral recess stenosis without central canal stenosis, pain related to disc herniation with radicular symptoms based on radiological or neurological tests (neurological tests include straight-leg raising test, suppress of reflex, motor weakness, sensory dysfunction), cauda equina syndrome, deformity (scoliosis) with an angle of less than 25 degrees in lumbosacral spine, grade I and II spondylolisthesis
Evidence of lumbar spinal stenosis based on MRI according to Boden criteria
Fixation and fusion have been done in maximum 5 levels for the patient
The patient has an indication for screw fixation at S1 level (S1 screw), including L5-S1discectomy, L5-S1 spondylolisthesis, Kissing facet that requires facetectomy.
The patient has undergone interbody fusion with Posterior lumbar interbody fusion (PLIF) method
More than 50% of the graft used in the operation area should be autograft
Iranian citizenship
It is possible to follow up the patient and be available to participate in routine follow-up sessions

Exclusion Criteria

Response to non-surgical treatments
Vertebral fracture, tumor or infection in the lumbosacral spine, inflammatory spondylopathy and grade III and IV spondylolisthesis.
Suspicion of osteoporosis based on lumbosacral radiography (bone densitometry is done to prove the disease in suspected cases and the loss of bone density (T score less than -2.5) which is average for a healthy and adult person of the same age as osteoporosis Considered to be)
Use of triparatide (Sinopar)
Scoliosis with a Cobb angle of more than 25 degrees
Sagittal imbalance with Sagittal vertical axis (SVA) greater than 9 cm
Hip flexion contracture based on Thomas test
L5-S1 disc height is not suitable before the operation and this space is collapse and fuse
Unilateral L5-S1 instrument
Revision surgery

pregnant women
contraindications for MRI
People who do not want to participate in the study despite explaining the benefits of the project and the efforts of the study team to participate
People who are not able to communicate in order to respond, such as deaf, blind people, speech problems, etc.
People suffering from mental disorders, mental retardation and any psychiatric disorder in the acute stage such as psychosis, who are not treated and are unable to cooperate.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiological fusion rate of the spine at L5-S1 level. Timepoint: 6 month after operation. Method of measurement: Standing lateral and flexion-extension lumbosacral X-ray and determination of fusion rate according to Brantigan-Steffee classification.

Secondary Outcome Measures

Name	Time	Method
Post-operative complications. Timepoint: After the operation and during the follow-up. Method of measurement: Based on the observations of the surgeon and the patient's medical record and imaging findings after the operation and during the follow-up.;The patient's pain level based on Visual Analogue Scale (low back pain and lower limb pain) after the operation. Timepoint: Before the operation, 2 weeks and 6 months after the operation. Method of measurement: Visual analog scale (Low back pain, Lower limb pain).;Functional outcome of patient according to Oswestry disability index (ODI) after the operation. Timepoint: Before the operation, 2 weeks and 6 months after the operation. Method of measurement: Oswestry disability index (ODI).;Patient satisfaction with postoperative recovery. Timepoint: 2 weeks and 6 months after the operation. Method of measurement: Satisfaction questionnaire (Asking 4 questions to the patient).