]>
IRCT20210308050630N1 IRCT 2021-06-10 Shiraz University of Medical Sciences Studying therapeutic effects of Methylprednisolone Acetate and Lidocaine injection in patients with Fibromyalgia Studying the therapeutic effects of Methylprednisolone Acetate and lidoaine injection at GB-20 acupuncture point compared to oral Duloxetine in patients with Fibromyalgia 2021-03-09 anticipated 30 Complete https://irct.ir/trial/54893 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, block randomization method is used. Blocking is usually used to balance the number of samples assigned to each of the study groups. The size of all blocks is equal and, in this study, we will have blocks with size of 4, including 2 patient in the duloxetine group and 2 patient in the methyl group. Randomization is done by computer using Random allocation software version 1.0.0. For concealment, we use random allocation concealment using opaque sealed and sequentially numbered envelopes, so that the assigned group is not known before the individual is assigned. In this method, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the envelopes are glued and placed in a box, respectively. Based on the order of entry of eligible patients into the study, one of the envelopes is opened in order and their assigned group is revealed. 3 Fibromyalgia. Intervention 1: Intervention group: for this group only once injection of the mixture of Methylprednisolone acetate and Lidocaine 2% will be performed ,to each GB-20 accupoint ,each side 3 cc with needle gauge 23-(Methylprednisolone acetate is from Iran Hormon Pharmaceutical and Lidocaine is from Caspian Tamin Pharmaceutical). Intervention 2: Control group:for this group Duloxetine cap 30 mg is given once daily which after 1 week it will be two times daily.duloxetine is a drug from SNRI group which has FDA approval for treatment of firomyalgia.the medication well be given for 8 weeks. duloxetine is from Abidi pharmaceutical. Yes - There is a plan to make this available What will be shared: all available data can be shared after making people unidentifiable. When: access period starts one year after publiushing the results To whom: Every one can have access to this information Conditions: If the information in this study improves the scientific process. Where to obtain: dr.navidahmadi.pmr@gmail.com 00989122415918 How to obtain: after sending the desired message ,all authors of this study will be consulted if permitted ,all information will be sent within 3 weeks maximum. Comments:
public Navid Ahmadi
No.4 abaeeyan street,abaeeyan,zand street
Shiraz Iran (Islamic Republic of) ۷۱۳۴۸-66676 +98 71 3230 9473 dr.navidahmadi.pmr@gmail.com Shiraz University of Medical Sciences scientific Navid Ahmadi
ٔNo.4Abaeeyan street,Abaeeyan street,Zand street
Shiraz Iran (Islamic Republic of) 71348-66676 +98 71 3230 9473 dr.navidahmadi.pmr@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) patient diagnosed with fibromyalgia base on American College of Rheumatology guideline. Completing and signing the conscious consent form Abdominal pain, depression and headache for the last 6 mounths. pain in dfferent parts of body like Neck-Jaw-Shoulder-upper Arm-lower Arm-Chest-Abdomen-Back-upper Thigh at both sides of the body for the last week problems like weakness ,after sleep fatigue, impaired thought and memory for the last week no limit no limit Female Patients with Diabetes mellitus-Thyroid disease-Neuropathy-Lyme disease-Hepatitis patients who use medications like ASA-Metoclopramide-Tamoxiphen-TCA-alfa agonists-Beta cyprotrone uncontroled mental illness M79.7 Fibromyalgia Treatment - Drugs Treatment - Drugs Intervention group: for this group only once injection of the mixture of Methylprednisolone acetate and Lidocaine 2% will be performed ,to each GB-20 accupoint ,each side 3 cc with needle gauge 23-(Methylprednisolone acetate is from Iran Hormon Pharmaceutical and Lidocaine is from Caspian Tamin Pharmaceutical) Control group:for this group Duloxetine cap 30 mg is given once daily which after 1 week it will be two times daily.duloxetine is a drug from SNRI group which has FDA approval for treatment of firomyalgia.the medication well be given for 8 weeks. duloxetine is from Abidi pharmaceutical. Body pain. Timepoint: Before treatment-2-4-8 weeks later. Method of measurement: Visual Analogue Scale. Functional status. Timepoint: Before treatment -2-4-8 weeks after treatment. Method of measurement: FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ ). Shiraz University of Medical Sciences Approved 2020-10-26 Ethics committee of Shiraz University of Medical Sciences No.11,Ansar Ave,Koohbar Blvd,Zerehi Shiraz Fars Iran (Islamic Republic of)