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IRCT20241004063253N1 IRCT 2024-10-13 Karaj University of Medical Sciences Investigating the local effectiveness of ordinary gadim scorpion oil on the pain of patients with chronic sciatica - Investigating the topical application of Hemiscorpius lepturus oil prepared based on the sources of Iranian traditional medicine on the pain of chronic sciatica patients: A double-blind randomized clinical trial 2024-11-01 anticipated 84 Complete https://irct.ir/trial/79436 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Due to compliance with ethical principles and not depriving patients of common treatments, study participants (both groups) can take diclofenac 25 mg tablets up to 2 times a day, one at a time, if they feel the need and have severe pain. As much as medicinal ointment is more effective than placebo on the pain intensity of patients, the amount of oral pain reliever (diclofenac) should be lower in the first group than in the second group (placebo ointment recipient). Accordingly, the participants are asked to write down the number of diclofenac consumed per day and finally inform the presenter, Randomization description: Random block method is used to divide people into two groups. The first group uses oleogel containing scorpion oil and placebo (oleogel without scorpion oil) is used on the second group. Simple Random Sampling (Simple Random Sampling) is one of the statistical sampling methods in which people in the community have an equal chance of being selected. In this method, each element of the desired statistical population has an equal chance to be selected. In this method, the needed people or objects are randomly selected from the list of the statistical population that is numbered and prepared for this purpose. According to the law of probability, the selected people should have the same characteristics as the society from which they were selected. The advantage of the authentication block method is the balance of the number of participants in two groups, Blinding description: Medicines and placebo are in similar tubes with the same shape, color and smell. The specific codes are written by the pharmacist on the label of the medicine container and the placebo so that the patients and the researcher do not know the meaning of the codes. 3 Chronic Sciatica. Intervention 1: Intervention group: Recipient of topical ointment containing scorpion oil: 3 times a day (morning, noon, night) each time in the size of 2 knuckles in the lumbar area (from L1 down), buttock area to the middle of the back of the thigh on the side that hurts, for 4 The week will be rubbed along with the massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time. Intervention 2: Control group: recipient of topical ointment containing liquid paraffin: 3 times a day (morning, noon, night) each time the size of 2 knuckles in the lumbar region (from L1 down), buttock region to the middle of the back of the thigh on the side that has pain. It will be applied for 4 weeks along with massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time. 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 further information.
public Amir hossein Kia
Faculty of Pharmacy, Alborz University of Medical Sciences.,Valiasr Blvd.,Shura Blvd.,Azimieh.,Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3256 7175 amirhosseinkia78@gmail.com Karaj University of Medical Sciences scientific Amir hossein Kia
Faculty of Pharmacy, Alborz University of Medical Sciences.,Valiasr Blvd.,Shura Blvd.,Azimieh.,Karaj
Karaj Iran (Islamic Republic of) 3149779453 +98 26 3256 7175 amirhosseinkia78@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) 1- A patient with chronic sciatica pain (chronic lumbar radiculopathy, which is defined in this study as low back pain (from the L1 region and below it in the lower back region) which spreads unilaterally to one leg and sharp, burning pain with numbness and with or without tingling.) to continue for at least 12 weeks or more.2- Age above 18 years3- Pain equivalent to 1 or more based on VAS criteria4- Willingness of patients to cooperate in the study5- People without communication problems (sight, hearing, speaking and understanding).6- Pain that is not due to malignancies, inflammatory joint and rheumatic diseases such as rheumatoid arthritis, blood diseases and coagulation and infectious diseases.7- Don't have congenital abnormalities of the spine, bone fractures, scoliosis, kyphosis and spondylosis.8- Not a candidate for surgery.9- Absence of any history of surgery in the back area10- Not having a history of alcohol and narcotic drugs11-18.4 <BMI<35 18 years no limit Both 1- Pregnancy or breastfeeding2- causing severe side effects3- Severe sensitivity to any of the drugs used in the study4- Lack of consent to continue participating in the study5- Patients with a history of lumbar disc surgery6- Concurrent acute illness or accident during the study7- People suffering from favism8- Intensification of the patient's pain and its lack of control9- Using non-pharmacological pain relief treatments from any medical school such as acupuncture, massage, yoga, etc.10- Use of painkillers outside the study program during the study11- Symptoms of horse tail syndrome include numbness and weakness of both legs, numbness of the perineum, pain in the anal area, paralysis of the sphincters.12- Occurrence of clinical symptoms during the treatment that, in the doctor's opinion, require further investigation. M00-M99 Disease of the musculoskeletal system and connective tissue Treatment - Drugs Placebo Intervention group: Recipient of topical ointment containing scorpion oil: 3 times a day (morning, noon, night) each time in the size of 2 knuckles in the lumbar area (from L1 down), buttock area to the middle of the back of the thigh on the side that hurts, for 4 The week will be rubbed along with the massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time. Control group: recipient of topical ointment containing liquid paraffin: 3 times a day (morning, noon, night) each time the size of 2 knuckles in the lumbar region (from L1 down), buttock region to the middle of the back of the thigh on the side that has pain. It will be applied for 4 weeks along with massage. If they feel the need and have severe pain, they can take diclofenac 25 mg tablets up to 2 times a day, one at a time. Severity of leg and back pain. Timepoint: at the beginning of the study (before the start of the intervention) and 7, 14, 21 and 28 days after the start of the study. Method of measurement: Visual Analogue Scale for leg and back pain intensity. The degree of disability of patients. Timepoint: before the start of the study and 4 weeks after the start of the study (end of the study). Method of measurement: Questionnaire Oswestry Disability Index. The number of diclofenac tablets taken daily. Timepoint: Length of study. Method of measurement: number. Skin Adverse effect. Timepoint: Days 3, 7, 14, 21 and 28 after the start of the study. Method of measurement: Skin side effects form based on CTCAE version 5 (Common Terminology Criteria for Adverse effects). Karaj University of Medical Sciences Approved 2024-09-18 Research Ethics Committees of Alborz University of Medical Sciences Deputy Research Building., Shahid Safarian Alley., 45-meter Golshahr St., Karaj Karaj Alborz Iran (Islamic Republic of)