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IRCT20190831044650N1 IRCT 2020-03-02 Islamic Azad University Qaemshahr Branch The Effects of spinal stabilization and Vitamin D on the tumor necrosis factor-α and interleukin-10 in women with Chronic Low Back Pain The Effects of spinal stabilization exercise and Vitamin D intake on the levels of tumor necrosis factor-α and interleukin-10 in women with Chronic Low Back Pain 2019-12-30 anticipated 48 Complete https://irct.ir/trial/45116 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects will be divided into four groups of control, exercise, vitamin D and combination (exercise + vitamin D) using simple randomization table. First a number is assigned to each person. Then, using the random number table of each selected number, it is assigned to one of the groups at random and will continue until the number of individuals in each group is completed. Therefore, the researcher will have no option to change or predict the status of individuals. Random concealment will be done by a third person who does not participate in other stages of intervention, Blinding description: Participants, evaluators, and analysts will be blind. The researcher will administer vitamin D capsules (50,000 units) to vitamin D and combination (vitamin D + exercise) individuals as well as placebo to control and exercise groups. N/A chronic low back pain. Intervention 1: Intervention group 1: Exercise group will perform 8 weeks of spinal stabilization exercises consisting of 3 sets of 8 stretching and isometric exercises with one minute rest between exercises, three sessions per week. Each exercise session starts from 3 seconds in the first week to 18 seconds in the fifth week, continuing through the eighth week (with a gradual increase of 3 seconds per week).Also, they will also take a placebo capsule weekly. Intervention 2: Intervention group II: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks in a single blind manner. Intervention 3: Intervention group 3: Subjects in this group will have 8 weeks of spinal stabilization exercises similar to the exercise group and will consume 50,000 IU of vitamin D capsules once a week in a single blind manner. Intervention 4: Control group: There is no intervention in the control group and they are given placebo in a single blind manner. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Masoumeh Habibian
7 kilometers from Allameh Tabari Street, Islamic Azad University of Ghaemshahr Branch, Ghaemshahr, Iran.
Qaemshahr Iran (Islamic Republic of) 4765161964 +98 11 4224 1041 habibian_m@yahoo.com Qaemshahr branch, Islamic Azad University scientific masoumeh habibian
7km Allameh Tabarasi street, Qaemshahr Branch, Islamic Azad University, Qaemshahr
Qaemshahr Iran (Islamic Republic of) 4765161964 +98 11 4224 1041 habibian_m@yahoo.com Qaemshahr branch, Islamic Azad University Iran (Islamic Republic of) Having chronic low back pain for more than three months Pain score (based on visual analogue scale) moderate Not having regular exercise for the past six months 30 years 50 years Female Use of specific drugs smoking Pregnancy Treatment - Other Treatment - Other Treatment - Other N/A Intervention group 1: Exercise group will perform 8 weeks of spinal stabilization exercises consisting of 3 sets of 8 stretching and isometric exercises with one minute rest between exercises, three sessions per week. Each exercise session starts from 3 seconds in the first week to 18 seconds in the fifth week, continuing through the eighth week (with a gradual increase of 3 seconds per week).Also, they will also take a placebo capsule weekly. Intervention group II: Vitamin D group, who take 50,000 IU of vitamin D capsules once a week for 8 weeks in a single blind manner Intervention group 3: Subjects in this group will have 8 weeks of spinal stabilization exercises similar to the exercise group and will consume 50,000 IU of vitamin D capsules once a week in a single blind manner. Control group: There is no intervention in the control group and they are given placebo in a single blind manner. Tumor necrosis factor-α. Timepoint: Prior and after interventions. Method of measurement: Using the ELISA method. Interleukin-10. Timepoint: Prior and after interventions. Method of measurement: Using the ELISA method. C reactive protein. Timepoint: Prior and after interventions. Method of measurement: Using the ELISA method. 25- hydroxy vitamin D. Timepoint: Prior and after interventions. Method of measurement: Using the ELISA method. Pain level. Timepoint: Prior and after interventions. Method of measurement: Visual Analogue Scale. Severity of disability. Timepoint: Prior and after interventions. Method of measurement: the oswestry disability Questionnaire. Sleep quality. Timepoint: Prior and after interventions. Method of measurement: Petersburg Sleep Questionnaire. Quality of Life. Timepoint: Prior and after interventions. Method of measurement: SF-36 Quality of Life Questionnaire. Aspartate aminotransferase. Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Alkaline phosphatase. Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Alanine aminotransferase. Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Urea. Timepoint: Before and after interventions. Method of measurement: Urease method. Uric acid. Timepoint: Before and after interventions. Method of measurement: Automatic colorimetric method. Creatinine. Timepoint: Before and after interventions. Method of measurement: Jaffe methods. Triglyceride. Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Total cholesterol. Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Low-density lipoprotein cholesterol (LDL-C). Timepoint: Before and after interventions. Method of measurement: Enzymatic method. High-density lipoprotein cholesterol (HDL-C). Timepoint: Before and after interventions. Method of measurement: Enzymatic method. Islamic Azad University Qaemshahr Branch Approved 2020-01-14 Ethics Committee of Babol branch, Islamic Azad University Department of physical education, Qaemshahr branch, Islamic Azad University, Qaemshahr, Iran Qeamshahr Mazandaran Iran (Islamic Republic of)