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IRCT20210718051931N1 IRCT 2022-04-30 Shiraz University of Medical Sciences Effect of acupuncture in relieving fatigue of multiple sclerosis Comparison study between the effect of amantadine and acupuncture in relieving fatigue in multiple sclerosis patients (randomized controlled trial) 2022-05-23 anticipated 60 Complete https://irct.ir/trial/57659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization, 6 blocks performed by sealed envelope site by a statistician. Based on the presented list, which includes a random sequence of letters A and B, eligible patients are included in the list in groups A and B, respectively. Group A then receives control treatment and group B receives intervention treatment, Blinding description: Patients fatigue status is determined with some questionnaires before and after the treatment, the person who assesses these questionnaires doesn't know about patients treatment group, also data analyzer doesn't know about patients' treatment group. N/A Multiple sclerosis. Intervention 1: Intervention group: This group is treated with 10 sessions of acupuncture by the researcher physician. The patient is lying on his side and lying down in a relaxed environment. After topical application with an alcohol swab, 14 sterile needle size 0.25*25mm manufactured by Huan-Qiu company placed on the desired points (on the head, neck, back and legs) obtained by various studies and clinical experience, patients lie still for 30 minutes, then the needles are taken out by the researcher physician. Number of sessions per week: 3 sessions. Before the sessions begin, patients are given the necessary training to improve bruising and possible pain. Intervention 2: Control group: 120 capsules of amantadine hydrochloride 100 mg, used twice a day for 2 months. One capsule in the morning after breakfast and one capsule in the afternoon after lunch with plenty of water, drug manufacturer: Fatek Shimi Pars Semnan - Iran. Yes - There is a plan to make this available What will be shared: Age and sex of patients, type of medication used for MS Questionnaires related to fatigue and general patient function before and after the intervention Informed consent form Statistical results When: one year after result publication To whom: All physicians and medical researchers Conditions: To use the results in other studies and for medical purposes Where to obtain: Correspondence with Dr. Mohammadjavad Hadianfard via email hadianj@sums.ac.ir How to obtain: Send an email and provide the relevant ID card Comments:
public Mohammadjavad Hadianfard
Zand St., Central Building of Shiraz Medical Science
Shiraz Iran (Islamic Republic of) 7194684334 +98 71 3628 6418 hadianj@sums.ac.ir Shiraz University of Medical Sciences scientific Mohammadjavad Hadianfard
Zand St., Central Building of Shiraz Medical Sciences
Shiraz Iran (Islamic Republic of) 7194684334 +98 71 3628 6418 hadianj@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with definite or possible multiple sclerosis and suffer from fatigue Patients suffering from fatigue of multiple sclerosis for more than 6 months and confirmed with FSS score more than 30 Age range between 18-50 Not consuming any other fatigue relieving drugs except amantadine in control group 18 years 50 years Both Probable cases of multiple sclerosis Pregnancy- lactating Acute fracture or trauma Patients with other chronic disease Patients with coagulation disorders Tobacco products use Refuse to continue the treatment Death Treatment - Devices Treatment - Drugs Intervention group: This group is treated with 10 sessions of acupuncture by the researcher physician. The patient is lying on his side and lying down in a relaxed environment. After topical application with an alcohol swab, 14 sterile needle size 0.25*25mm manufactured by Huan-Qiu company placed on the desired points (on the head, neck, back and legs) obtained by various studies and clinical experience, patients lie still for 30 minutes, then the needles are taken out by the researcher physician. Number of sessions per week: 3 sessions. Before the sessions begin, patients are given the necessary training to improve bruising and possible pain. Control group: 120 capsules of amantadine hydrochloride 100 mg, used twice a day for 2 months. One capsule in the morning after breakfast and one capsule in the afternoon after lunch with plenty of water, drug manufacturer: Fatek Shimi Pars Semnan - Iran Fatigue with FSS more than 30, quality of life improvement with SF-36. Timepoint: before treatment, immediately after treatment, 2 months post treatment. Method of measurement: FSS, SF-36 questionnaires. Shiraz University of Medical Sciences Approved 2021-07-18 Ethics committee of Shiraz University of Medical Sciences Zand Blvd Shiraz Fars Iran (Islamic Republic of)