Condition 1: sacroiliac joint pain. Condition 2: Spondylosis, arthrosis or osteoarthritis of spine, degeneration of facet joints. Condition 3: Spondylolisthesis. Condition 4: spondylosis with myelopathy. Condition 5: spondylosis with radiculopathy. Condition 6: Other spondylosis. Condition 7: Spondylosis, unspecified. Condition 8: Spinal stenosis. Condition 9: Spondylopathy, unspecified. Sacroiliitis, not elsewhere classified Spondylosis Subluxation and dislocation of lumbar vertebra Other s
Conditions
Interventions
Intervention 1: The first intervention group: lumbosacral spine surgery with fusion.Patients undergo surgery in one of two ways. Decompression group without fusion and decompression group plus fusion
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Obtaining written informed consent from the patient to participate in the study Age over 18 years Age below 75 years Patients suffering from lumbar spinal canal stenosis along with low grade degenerative spondylolisthesis of the lumbar spine which has been examined by clinical examinations and imaging methods and their disease has been confirmed by a neurosurgeon and spine specialist and a radiologist Ineffectiveness of non-surgical conservative methods in controlling the patient's symptoms and pain and disability No history of lumbar spine surgery Presence of a clear indication for decompression with or without fusion in the patient Having Iranian citizenship It is possible to follow up the patient and be available to participate in routine follow-up sessions
Exclusion criteria
Exclusion criteria: Vertebral fracture tumoral or metastatic lesions of vertebrae Infection in the lumbosacral spine Inflammatory spondylopathy Presence of SIJ disease Patients who have already undergone lumbosacral spine surgery, including revision cases Interior fusion indication (insertion of interbody cage) Chronic pain problems, such as Fibromyalgia and other Rheumatological diseases, chronic pain associated with inflammation or irritation of the muscle or fascia around the muscle Suspicion of Osteoporosis based on simple lumbosacral radiography (Bone Densitometry is performed to prove the disease in suspected cases) People who have Scoliosis with a Cobb angle of more than 25 degrees Sagittal Imbalance with (Sagittal Vertical Axis - SVA) more than 9 cm Presence of Hip flexion contracture based on examination with Thomas test Simultaneous surgical indication of lumbar canal stenosis and cervical canal stenosis Pregnant women Presence of contraindications for MRI The patient's unwillingness to participate in the study despite explaining the benefits of the plan and the efforts of the study team to attract their participation People who are unable to communicate in order to answer study questions, such as Deaf, Blind, Speech problems People suffering from Mental and Psychological disorders, Mental retardation and any Psychiatric disease in the acute stage such as Psychosis, who have not been treated and are unable to cooperate Sciatica pain radiating below the knee, work injury, litigation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in SF-36 Quality of life index summary score. Timepoint: One month and 3 months after surgery. Method of measurement: Quality of life Criteria: The patients' perception of their health status in life and their level of satisfaction with this situation will be recorded and stored in the study plan database in three stages according to the items listed in the above measurement and for final analysis. In this study, the 36-question quality of life questionnaire (SF-36) will be used, which has 36 questions and consists of 8 subscales, and each subscale consists of 2 to 10 items. The eight subscales of this questionnaire are: 1) Physical function (PF) 2) Role disruption due to physical health (RP) 3) Role disruption due to emotional health (RE) 4) Energy/fatigue (EF) 5) Emotional well-being (EW) 6 ) social function (SF) 7) pain (P) 8) general health (GH). Due to the complexity of scoring this questionnaire, its full scoring takes place in several stages. Also, at the end of scoring, two general subscales will be obtained for this questionnaire, which are: 1) physical health subscale, 2) mental health subscale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in ODI Disability Index score. Timepoint: One month and 3 months after surgery. Method of measurement: The degree of disability caused by back pain will also be measured in three stages according to the above mentioned times and will be recorded and stored in the database software of the study plan. The Oswestry Disability Index (ODI) questionnaire will be used to measure the level of patients' inability to perform daily activities, which includes 10 sections and each section has a score between 0 and 5, where a score of 0 equals "no pain" and a score of 5 equals " "The worst pain imaginable for the patient", so the first sentence in each section has zero points and the last sentence has 5 points. Therefore, the total raw score will be between zero and 50 points, and a higher score indicates more disability in the patient. To express the test result as a percentage, multiplying the raw score by 2 will be used. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactToufigh Mohaddes Javadi
Tehran University of Medical Sciences
Outcome results
None listed