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IRCT20231127060204N1 IRCT 2024-05-07 Tehran University of Medical Sciences Investigating the effect of lumbosacral spine fusion in the occurrence of sacroiliac joint syndrome (SIJS) after lumbar surgery. Comparison of the incidence of chronic sacroiliac joint pain (SIJP) following lumbar surgeries with and without lumbosacral spine fusion in spinal stenosis patients with low-grade lumbar degenerative spondylolisthesis using a non-randomized clinical trial study method. 2024-05-04 anticipated 106 Complete https://irct.ir/trial/74218 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A 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. 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 (instrumental using screw and titanium rod). In the first intervention group, patients diagnosed with low-grade lumbar spondylolisthesis with lumbar stenosis and neurogenic lameness with or without lumbar radiculopathy and lumbar instability in flexion-extension radiography of the lumbar spine (movement of more than 3 to 14 mm at the level of listhesis) are included. Decompression and fusion surgery group. In all fusion patients, autogenous bone graft with the origin of lamina and spinous process was used. After surgery, patients enter the follow-up phase for three months and are monitored after one month and three months in terms of the occurrence of new back pain that is different from preoperative pain that is consistent with the criteria of sacroiliac joint syndrome (SIJS). And if SIJS occurs and is confirmed, they enter the next intervention phase (anesthetic block of the SIJ joint). Intervention 2: The second intervention group: lumbosacral spine decompression surgery without fusion.Patients undergo surgery in one of two ways. Decompression group without fusion and decompression group plus fusion (instrumental using screw and titanium rod). In the second intervention group, patients diagnosed with low-grade lumbar spondylolisthesis with lumbar stenosis and neurogenic lameness with or without lumbar radiculopathy without lumbar instability in flexion-extension radiography of the lumbar spine (movement less than 3 mm at the level of listhesis) are included in the surgical group. Decompression without fusion. After surgery, these patients enter the follow-up phase for three months and are monitored after one month and three months in terms of the occurrence of new back pain that is different from preoperative pain that is consistent with the criteria of sacroiliac joint syndrome (SIJS). and if SIJS occurs and is confirmed, they enter the next intervention phase (anesthetic block of the SIJ joint). Intervention 3: The third intervention group: Sacroiliac joint anesthetic block in lumbosacral spine surgery patients with fusion who have sacroiliac joint syndrome after surgery.After surgery, patients in the intervention groups of decompression with fusion and decompression without fusion enter the follow-up phase for three months. In the third intervention group, at each stage of follow-up (first and third month after surgery), each of the patients of the first and second intervention groups who have persistent back pain and new point tenderness whose pain is unilateral (or with unilateral spread) ; with diffusion topography consistent with sacroiliac origin, without diffusion below the knee, sacroiliac groove tenderness to palpation; positive at least 3 sacroiliac joint provocative examinations (thigh thrust, FABER, compression, Gaenslen's, distraction) and the absence of lumbar causality evidence (especially the absence of destruction of the adjacent disc in MRI and the absence of pseudarthrosis) with the diagnosis of sacroiliac joint syndrome (SIJS) ) enter the next intervention phase and are placed under the SIJ block. At each stage, the outcome is measured based on ODI and SF-36 criteria in the stage before injection and block and VAS criteria after injection.The criteria for positive provocative maneuvers to diagnose SIJ as the main source of pain includes the possibility of reproducing the patient's typical pain in the SIJ region; A positive test as a possible case and a positive 3 or more tests as a very likely case of SIJS is considered as a pain generator.In the detailed description of the intervention to perform the block, the skin over the sacroiliac joint is anesthetized with 1% lidocaine using a short needle. Carefully avoiding anesthetizing the periarticular ligaments, a 20-gauge 50mm needle is inserted into the lower part of the joint. One milliliter of non-ionic contrast material is injected to confirm the placement of the needle inside the joint, and then the joint is anesthetized with 2.5 milliliters of lidocaine 2% + 1 milliliter of triamcinolone + 1.5 milliliters of distilled water (5 milliliters in total). The amount of pain before the block was based on the VAS scale with the question "How much was your average pain this morning?" It was measured and measured again 15 minutes after the block and after 5 minutes of walking and sitting. The criteria for a positive block will include accurate injection of contrast inside the joint, as well as pain relief of the patient up to 75%. A positive block will be considered to confirm the diagnosis of sacroiliac syndrome. 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Where to obtain: Mailbox: Toufighmj@gmail.com Telegram: @toufighmj Cell: 00989143118540 Toufigh Muhaddes Javadi How to obtain: 1- Authentication as a medical researcher 2- Introducing a study that needs to use the reports of this study. 3- Send an e-mail request with the above documents, stating the reasons for the need for access and agreeing to comply with all the conditions listed in the conditions and objectives section of the subscription and using the results of this study in other clinical and research studies. Comments:
public Toufigh Mohaddes Javadi
No.10, 8th Alley, North Mosaddegh St, Mirdamad Blvd, postal code 1918885553
Tehran Iran (Islamic Republic of) 1918885553 +98 21 2222 1875 toufighmj@gmail.com Tehran University of Medical Sciences scientific Toufigh Mohaddes Javadi
No.10, 8th Alley, North Mosaddegh St, Mirdamad Blvd, postal code 1918885553
Tehran Iran (Islamic Republic of) 1918885553 +98 21 2222 1875 toufighmj@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 75 years Both 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 M46.1 M47 S33.1 M47.1 M47.2 M47.8 M47.9 M48.0 M48.9 Sacroiliitis, not elsewhere classified Spondylosis Subluxation and dislocation of lumbar vertebra Other spondylosis with myelopathy Other spondylosis with radiculopathy Other spondylosis Spondylosis, unspecified Spinal stenosis Spondylopathy, unspecified Treatment - Surgery Treatment - Surgery Diagnosis 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 (instrumental using screw and titanium rod). In the first intervention group, patients diagnosed with low-grade lumbar spondylolisthesis with lumbar stenosis and neurogenic lameness with or without lumbar radiculopathy and lumbar instability in flexion-extension radiography of the lumbar spine (movement of more than 3 to 14 mm at the level of listhesis) are included. Decompression and fusion surgery group. In all fusion patients, autogenous bone graft with the origin of lamina and spinous process was used. After surgery, patients enter the follow-up phase for three months and are monitored after one month and three months in terms of the occurrence of new back pain that is different from preoperative pain that is consistent with the criteria of sacroiliac joint syndrome (SIJS). And if SIJS occurs and is confirmed, they enter the next intervention phase (anesthetic block of the SIJ joint). The second intervention group: lumbosacral spine decompression surgery without fusion.Patients undergo surgery in one of two ways. Decompression group without fusion and decompression group plus fusion (instrumental using screw and titanium rod). In the second intervention group, patients diagnosed with low-grade lumbar spondylolisthesis with lumbar stenosis and neurogenic lameness with or without lumbar radiculopathy without lumbar instability in flexion-extension radiography of the lumbar spine (movement less than 3 mm at the level of listhesis) are included in the surgical group. Decompression without fusion. After surgery, these patients enter the follow-up phase for three months and are monitored after one month and three months in terms of the occurrence of new back pain that is different from preoperative pain that is consistent with the criteria of sacroiliac joint syndrome (SIJS). and if SIJS occurs and is confirmed, they enter the next intervention phase (anesthetic block of the SIJ joint). The third intervention group: Sacroiliac joint anesthetic block in lumbosacral spine surgery patients with fusion who have sacroiliac joint syndrome after surgery.After surgery, patients in the intervention groups of decompression with fusion and decompression without fusion enter the follow-up phase for three months. In the third intervention group, at each stage of follow-up (first and third month after surgery), each of the patients of the first and second intervention groups who have persistent back pain and new point tenderness whose pain is unilateral (or with unilateral spread) ; with diffusion topography consistent with sacroiliac origin, without diffusion below the knee, sacroiliac groove tenderness to palpation; positive at least 3 sacroiliac joint provocative examinations (thigh thrust, FABER, compression, Gaenslen's, distraction) and the absence of lumbar causality evidence (especially the absence of destruction of the adjacent disc in MRI and the absence of pseudarthrosis) with the diagnosis of sacroiliac joint syndrome (SIJS) ) enter the next intervention phase and are placed under the SIJ block. At each stage, the outcome is measured based on ODI and SF-36 criteria in the stage before injection and block and VAS criteria after injection.The criteria for positive provocative maneuvers to diagnose SIJ as the main source of pain includes the possibility of reproducing the patient's typical pain in the SIJ region; A positive test as a possible case and a positive 3 or more tests as a very likely case of SIJS is considered as a pain generator.In the detailed description of the intervention to perform the block, the skin over the sacroiliac joint is anesthetized with 1% lidocaine using a short needle. Carefully avoiding anesthetizing the periarticular ligaments, a 20-gauge 50mm needle is inserted into the lower part of the joint. One milliliter of non-ionic contrast material is injected to confirm the placement of the needle inside the joint, and then the joint is anesthetized with 2.5 milliliters of lidocaine 2% + 1 milliliter of triamcinolone + 1.5 milliliters of distilled water (5 milliliters in total). The amount of pain before the block was based on the VAS scale with the question "How much was your average pain this morning?" It was measured and measured again 15 minutes after the block and after 5 minutes of walking and sitting. The criteria for a positive block will include accurate injection of contrast inside the joint, as well as pain relief of the patient up to 75%. A positive block will be considered to confirm the diagnosis of sacroiliac syndrome. 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. 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. Tehran University of Medical Sciences Approved 2023-07-16 Educational, Research and Treatment Center of Dr. Shariati Hospital - Tehran University of Medical S No.10, 8th Alley, North Mosaddegh St, Mirdamad Blvd. Tehran Tehran Iran (Islamic Republic of)