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IRCT20200819048460N1 IRCT 2020-11-04 Ahvaz University of Medical Sciences Evaluation of the effect of hydrotherapy in lumbar disc herniation The effect of hydrotherapy in the treatment of patients with lumbar disc herniation 2018-04-23 anticipated 96 Complete https://irct.ir/trial/50520 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study computerized block randomization (block sizes of 4 and 6) will be carried out. An independent clinical epidemiologist, who will not be involved in the conduct of the study, uses a computerized block randomization program (STATA14 software) to produce the allocation codes. The randomization sequences will be concealed in lightproof, sealed envelopes. The research assistant opens sealed, numbered, opaque envelopes containing allocation codes. The eligible participants will be randomly divided into two equal groups (Hydrotherapy or control) according to the randomization list after signing informed consent form, Blinding description: Due to the allocation of a group to hydrotherapy, it is not possible to blind patients. But the second investigator of the research project who is blinded to the assignment of patients, will complete the questionnaire at the end of the treatment. Also the data will be analyzed without any information about group selection. N/A Disc bulging. Intervention 1: Intervention group: Patients assigned to this group undergo Hydrotherapy sessions, which include walking in a pool filled with water with a depth of 1.5 meters, twice a week, with each session lasting for two hours, for a duration of three to six months. Treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) is used twice a day. Naproxen capsules (500 mg, Twice a day Tolid Daru Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease. Intervention 2: Control group: Patients in this group will undergo daily treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) used twice a day. Naproxen capsules (500 mg, Twice Daily Tolid Daro Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Payam Mohammad Hosseini
Imam Khomeini hospital, 24m street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 3818 Payam_m_h@yahoo.com Ahvaz University of Medical Sciences scientific Payam Mohammad Hoseeini
Imam Khomeini Hospital, 24m street
Ahvaz Iran (Islamic Republic of) 6193673166 +98 61 3222 3818 Payam_m_h@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with lumbar disc herniation confirmed by an orthopedic specialist Consent to enter the study Absence of Cardiac disease (due to the possibility of complications of celecoxib consumption in coronary artery disease patients) Absence of gastrointestinal disease(like peptic ulcer disease) Absence of Mental Disorders related to water (like phobias) no limit no limit Both Hypersensitivity to naproxen or celecoxib that patients can not use any of these two drugs. M51.16 Intervertebral disc disorders with radiculopathy, lumbar region Treatment - Other Treatment - Drugs Intervention group: Patients assigned to this group undergo Hydrotherapy sessions, which include walking in a pool filled with water with a depth of 1.5 meters, twice a week, with each session lasting for two hours, for a duration of three to six months. Treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) is used twice a day. Naproxen capsules (500 mg, Twice a day Tolid Daru Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease. Control group: Patients in this group will undergo daily treatment with 500 mg Celecoxib capsules (Dr Aabidi Pharmaceutical Company) used twice a day. Naproxen capsules (500 mg, Twice Daily Tolid Daro Pharmaceutical Company, Tehran) is used instead of Celecoxib if the patients suffer from coronary artery disease. Back and lower limb pain score in patients with lumbar disc herniation based on Visual Analogue Scale. Timepoint: At the beginning of the intervention and 3 to 6 months after hydrotherapy and medication. Method of measurement: Visual Analogue Scale questionnaire. Daily quality of life score based on Oswestry low back pain disability questionnaire. Timepoint: En At the beginning of the intervention and 3 to 6 months after hydrotherapy and medication. Method of measurement: The Oswestry low back pain disability questionnaire. Ahvaz University of Medical Sciences Approved 2019-10-05 Ethics Committee of Ahwaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)