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IRCT20230919059473N1 IRCT 2023-10-09 Rafsanjan University of Medical Sciences effect of topical Boswellia oil on pain severity in patients with lumbar disc herniation Investigating the effect of topical Boswellia oil on pain severity in patients with lumbar disc herniation 2023-10-17 anticipated 60 Complete https://irct.ir/trial/72755 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The sampling method was accessible and randomly assigned to groups, classified based on important intervening variables, including pain score at the time of entering the study and gender. The number of samples in the groups was equal. In order to control the confounding factors and ensure the same number of samples in the groups, the random minimization method was used (table below). The first and second samples were randomly entered into the groups, and in the rest of the cases, attention was paid to the sum of the indicators in the groups. Sampling continued until the desired sample volume was reached, Blinding description: The patients were completely unaware of which intervention group they were in. But they were aware of participating in the intervention. 1 Patients with lumbar disc herniation. Intervention 1: In the intervention group, 30 ml droppers containing 10% frankincense oil (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use were provided to the patients. The patients were taught to use 10 drops (Razavi et al., 2019) of frankincense oil topically, twice a day for 6 weeks. It was explained to the patients that they should first massage the pain area a little and when they feel heat, put the oil on the massage area for a maximum of one minute. If the patient himself is not able to use the oil in the pain area, the second person should do it for him. Intervention 2: In the control group, olive oil was used as a placebo in the pain area. 30 ml droppers containing olive oil, in the same packaging, (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use, were provided to patients in the placebo group. The method of use is similar to the conditions of using frankincense oil. It was emphasized to the patient to use the drops without interruption and at specified intervals. To reduce the possibility of forgetting, the patients were asked to use the oil at the same times and set a reminder on their mobile phones to remind them when to use the drops. The number of times and how the oil was consumed was tracked by the researcher once a week by phone and recorded in the relevant form. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fatemeh Tavakoli
Central organization - Imam Ali Boulevard - Rafsanjan
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 fatemetavakoli1998@gmail.com Rafsanjan University of Medical Sciences scientific Dr. Shahin Heidari
Central organization - Imam Ali Boulevard - Rafsanjan University of Medical Sciences
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 kermanshah3252@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Age between 20 and 60 years Not suffering from nervous and mental diseases Lumbar disc herniation based on neurologist and MRI diagnosis Lack of sensitivity to frankincense oil Not having wounds and lesions at the place of use Absence of diabetes mellitus Absence of absolute rest Absence of immune system problems in a person such as lupus erythematosus, multiple sclerosis (MS) Not having a history of surgery in the back area Absence of alcohol and drug addiction Not using other complementary methods for pain relief Not taking anticoagulants Absence of pregnancy and breastfeeding The amount of pain is more than 3 on the numerical-visual scale of VAS 20 years 60 years Both Desire to quit studying The need for surgery during the study The need to inject coronet during the study Not performing intervention for more than two consecutive days or one alternate week Change or exacerbation of back pain Incidence of sensitivity and allergy during the implementation of the study, which is characterized by symptoms such as skin rashes. M51.86 Other intervertebral disc disorders, lumbar region Treatment - Other Treatment - Other In the intervention group, 30 ml droppers containing 10% frankincense oil (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use were provided to the patients. The patients were taught to use 10 drops (Razavi et al., 2019) of frankincense oil topically, twice a day for 6 weeks. It was explained to the patients that they should first massage the pain area a little and when they feel heat, put the oil on the massage area for a maximum of one minute. If the patient himself is not able to use the oil in the pain area, the second person should do it for him. In the control group, olive oil was used as a placebo in the pain area. 30 ml droppers containing olive oil, in the same packaging, (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use, were provided to patients in the placebo group. The method of use is similar to the conditions of using frankincense oil. It was emphasized to the patient to use the drops without interruption and at specified intervals. To reduce the possibility of forgetting, the patients were asked to use the oil at the same times and set a reminder on their mobile phones to remind them when to use the drops. The number of times and how the oil was consumed was tracked by the researcher once a week by phone and recorded in the relevant form. Evaluation of the effect of frankincense oil on pain: This study can show whether the local consumption of frankincense oil makes a significant change in the pain intensity of lumbar disc herniation patients. Timepoint: Immediately after the end of the intervention. Method of measurement: Visual Pain Scale Questionnaire (VAS). Rafsanjan University of Medical Sciences Approved 2023-05-03 Research Ethics Committees of Rafsanjan University of Medical Sciences Rafsanjan University of Medical Sciences - Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)