The efficacy of vitamin D and oral alendronate in patients with low back pain and modic changes who underwent lumbar fusion surgery.

The effecacy of vitamin D and oral alendronate in patients with low back pain and modic changes who underwent lumbar fusion surgery.

The effecacy of vitamin D and oral alendronate in patients with low back pain and modic changes who underwent lumbar fusion surgery.

This clinical trial was performed on 90 patients aged 20-65 years old referred to an Sari neurosurgeon clinic who needed laminectomy surgery and lumbar vertebrae fusion with pedicular scrow up to 4 vertebral levels. Then, for patients, a checklist filled with demographic characteristics, smoking, occupation, type of treatment, and type of disease is filled up. Then, the radiologist will be aware of the patient's clinical picture of the MRI scan. Modic changes are reported in dominant in any disk variation .  At the beginning of the study, the severity of pain was completed on the basis of the Visual Analogue Scale and the individual's ability to perform daily tasks based on the Oswestry Disability Index. The levels of vitamin D in preoperative patients are taken. According to the "random sample table", the patients are divided into 3 randomized groups of 30, including the Fusion group and the fusion group and alendronate, and the fusion group and vitamin D group. After 6 months, the lumbar magnetic resonance imaging (MRI) and clinical parameters of pain are recorded based on VAS, (ODI) in months 1, 3, and 6, and then recorded .

Entry criteria: Patients with degenerative diseases include lumbar spinal disk opathy, spinal stenosis, lumbar spinal listesis, requiring laminectomy and lumbar fusion with pedicles scrow up to 4 vertebral levels, and surgical identification is determined by a neurosurgeon . Patients with traumatic lesions ,neoplastic,infectious and the history of surgery ,diabetic,disabling background and rheumatic disorders are not included in the study. People who do not modic change in MRI are not included in the study. Patients with renal failure and GFR below 40 will not receive alendronate.

Patients were divided into 3 groups of 30, including fusion (control), fusion and alendronate (interventional), fusion and vitamin D (interventional) groups. The fusion group needs laminectomy and lumbar spine sciatica with up to 4 vertebral vertebrae. The alendronate group, in addition to fusion surgery, received 70 mg oral alendronate for 6 months as an adjunct therapy every 2 weeks. In group 3, in addition to fusion surgery, 50,000 units of vitamin D are received monthly for 6 months.

Pain severity;Modic change

Randomize numbers table

After taking surgery and treatment informed consent of patients, just patients surgeon as main project researcher will informed about the kind of drug investigation and follow up of the patients.

The total data of the participants in the test and analysis of the test will be available upon completion of the study if patients are satisfied.

Start the access period 6 months after printing the results

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For systematic review studies and after permission from patients

Kaveh Haddadi k.haddadi@mazums.ac.ir

After sending the email, the data will be provided to the applicant within 5 months