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IRCT20210919052522N1 IRCT 2021-10-10 Tehran University of Medical Sciences The Effect of topical Henna oil on pain in chronic sciatica patients The Effect of topical Henna (Lawsonia inermis L.) oil on pain in chronic sciatica patients; A double-blind randomized clinical trial 2021-10-11 anticipated 81 Complete https://irct.ir/trial/58917 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation to groups is done by balance block randomization method with triple blocks(using the related table to random permutations). The randomized list is provided by a statistical consultant. In this way, the group code of each patient who enters the study (in the order of patient admission) is determined based on a randomized list. These codes, which belong to the three groups of henna oil(in sesame oil base) group and sesame oil group and the placebo group(mineral oil) have been determined by a statistical consultant; and in addition to patients, the researcher will not be informed until the end of the study, Blinding description: Drugs and the placebo are packed in similar bottles with the same shape, color and smell. The proprietary codes set by the pharmacist on the bottle of drugs and the placebo. Patients and the researcher are not aware of codes. 3 Chronic sciatica. Intervention 1: First intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of henna oil(in sesame oil base) on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Intervention 2: Second intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of sesame oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Intervention 3: Control group: Chronic sciatica patients use topically 10 drops(half a cc) of mineral oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Narges Lavari
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 n-lavari@razi.tums.ac.ir Tehran University of Medical Sciences scientific Narges Lavari
No.27, School of Traditional Medicine, Sarparast St., Taleghani Ave.
Tehran Iran (Islamic Republic of) 1416663361 +98 21 8899 3656 n-lavari@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients with chronic unilateral sciatica pain (lumbar radiculopathy in this study defined chronic back pain that spread to a leg. Pain described as sharp, burning with numbness and/or tingling.) For at least 3 months and more Age 18 to 65 years Pain score of 1 or more on visual analog scale (VAS) of 0 to 10 Willingness of patients to participate in the study Patients without communication problems (vision, hearing, speaking and understanding) Pain not attributable to malignancy, inflammatory arthritis such as rheumatoid arthritis, or blood diseases and coagulation and infectious diseases Patients without congenital spinal abnormalities, bone fractures, scoliosis, kyphosis and spondylosis Patients are not candidate for surgery No history of surgery in the lower back No history of alcohol and narcotic abuse Body mass index(BMI) between 18.5 to 34.9 18 years 65 years Both Pregnancy or lactation Severe allergy to any of the medications used in the study Severe side effects Unwillingness to continue participating in the study No use of oils more than twice in a row Occurring acute illness or accident during the study Patients with G6PD Aggravation of pain Use of other complementary and alternative therapies Use of analgesics out of the study during the study Cauda equine syndrome symptoms include numbness and weakness in both legs, pain in the anal area, perineal numbness, paralysis of the sphincters Symptoms require further investigation during the study M00-M99 Diseases of the musculoskeletal system and connective tissue Treatment - Drugs Treatment - Drugs Placebo First intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of henna oil(in sesame oil base) on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Second intervention group: Chronic sciatica patients use topically 10 drops(half a cc) of sesame oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Control group: Chronic sciatica patients use topically 10 drops(half a cc) of mineral oil on the low back and unilateral painful area from gluteal to middle posterior of thigh without massage, 3 times a day, for 4 weeks. Pain intensity. Timepoint: At the beginning of the study (before the intervention) and 7, 14 and 28 days after the start of the study. Method of measurement: Visual Analogue Scale. Diclofenac tablets taken daily. Timepoint: during study. Method of measurement: Number. Disability. Timepoint: Before the start of the study and 4 weeks after the start of the study(the end of the study). Method of measurement: Oswestry disability questionnaire. Quality of Life. Timepoint: Before the start of the study and 4 weeks after the start of the study(the end of the study). Method of measurement: The Short form health survey 36 questionnaire (SF-36). Skin side effects. Timepoint: Days 3, 7, 14 and 28 days after the start of the study. Method of measurement: Form of skin side effects based on CTCAE(Common Terminology Criteria for Adverse) version 5. Tehran University of Medical Sciences Approved 2021-09-19 Ethics committee of Tehran University of Medical Sciences Sixth Floor, Central Office of Tehran University of Medical Sciences, Ghods Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)