Methods
neurogenic claudication, low back pain, lumbar spinal stenosis, scoliosis, neuropathy, infection, canal stenosis
LUMBAR SPINAL STENOSIS, SCOLIOSIS, NEUROPATHY, DIABETES MELLITUS, SPONDYLOLISTHESIS, KNEE OSTEOARTHRITIS, CAUDA EQUINA SYNDROME, INFECTION, BLIND, COAGULOPATHY
This randomized, double-blind, parallel-group clinical trial in a 1:1 allocation ratio was conducted on patients with lumbar spinal stenosis requiring intervention referred to Shahid Modarres Hospital in Tehran, Iran, from September 2019 to December 2020. All patients signed written informed consent before enrollment. The Ethics Committee approved the study protocol of Shahid Beheshti University of Medical Sciences. The trial was registered on the Iranian Clinical trial Registry with identification number IRCT IRCT20090704002117N2 (registration date: 07/08/2019). Patients were able to leave the study at any time if they were reluctant to continue the trial. This study conforms to all CONSORT guidelines and reports the required information accordingly.In simple randomization with a 1:1 allocation ratio, 50 patients were randomly divided into two groups of 25, selected using a computer-generated list of random numbers. A physical medicine and rehabilitation resident generated the allocation sequence, enrolled patients, and assigned them to interventions. Participants and assessors were blinded to type of treatment. Due to the presence of ozone gas, there was no way to blind the physician. Inclusion criteria in this study were duration of symptoms more than 1 month and less than 1 years, Visual Analog Scale (VAS) score equal to or greater than 7, age between 50 and 70 years, body mass index (BMI) between 20 and 32 kg/m2, neurogenic claudication and magnetic resonance imaging (MRI) confirmation of lumbar spinal stenosis. The presence of neurogenic claudication was mandatory for inclusion criteria. Patients with low back pain without neurogenic claudication were not included in the study. Exclusion criteria were uncontrolled diabetes mellitus, neuropathy, spondylolisthesis, extruded disc, grade 4 knee osteoarthritis, history of previous lumbar spine surgery, scoliosis, pregnancy, clinical or laboratory evidence of infection, coagulopathy, and symptoms of cauda equina syndrome. In addition, we decided to exclude patients whose symptom duration was less than 1 month since we still hoped that they could recover with other treatments. Regarding the increase in duration of symptoms to more than 12 months, even though there is no contraindication for injection, we also excluded this group from the study. It is due to the possibility of non-response to caudal injection and depriving patients of surgical treatment.In addition, both groups were given similar therapeutic exercises for lumbosacral canal stenosis. The purpose of these exercises was to reduce extension forces on the lumbar spine. These exercises include hip flexor, hamstring, and lumbar paraspinal muscles stretching along with abdominal (pelvic tilts and trunk raise) and gluteal strengthening. Frequency, dose, and instruction of these exercises were prescribed based on Bodack’s study entitled “therapeutic exercise in the treatment of patients with lumbar spinal stenosis” [