Studying the therapeutic effects of Methylprednisolone Acetate and lidoaine injection at GB-20 acupuncture point compared to oral Duloxetine in patients with Fibromyalgia
Studying the therapeutic effects of injection of methylprednisolone acetate and lidocaine in gallbladder-20 (GB-20)acupuncture point in reducing pain of patients with Fibromyalgia
Design
Clinical trial in phase 3 with 2 parallel groups randomized with block randomization method(with same block length) on 30 patients.
Settings and conduct
visiting fibromyalgia patients will take place in clinic of rajaee hospital of shiraz city.
after filling out the informed consent form and fibromyalgia impact questionnaire and visual analog scale one of the methylprednisolone injection or oral duloxetine will be given to the patient .on follow up 2,4,8 weeks later all the questionnaires will be filled again .
Participants/Inclusion and exclusion criteria
inclusion criteria:1-diffuse body pain in different body parts both side of the body during the last week.2-problems like weakness-after sleep fatigue-Impaired thought and memory.3-abdominal pain ,depression and headache in the last 6 mouths
exclusion criteria:1-patinets who have Diabetes- thyroid dysfunction-Neuropathy-Lyme disease-hepatitis C.2-patient with uncontrolled psychiatrics disease 3.individuals who use medications which have drug interaction with duloxetine
Intervention groups
Intervention group :patient with fibromyalgia who will receive methylprednisolone and lidocaine injection at GB-20 accupoint.
control group :patient with fibromyalgia who will receive oral duloxetine.
Main outcome variables
Body pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210308050630N1
Registration date:2021-06-10, 1400/03/20
Registration timing:registered_while_recruiting
Last update:2021-06-10, 1400/03/20
Update count:0
Registration date
2021-06-10, 1400/03/20
Registrant information
Name
Navid Ahmadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3230 9473
Email address
dr.navidahmadi.pmr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-09, 1399/12/19
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the therapeutic effects of Methylprednisolone Acetate and lidoaine injection at GB-20 acupuncture point compared to oral Duloxetine in patients with Fibromyalgia
Public title
Studying therapeutic effects of Methylprednisolone Acetate and Lidocaine injection in patients with Fibromyalgia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
No.11,Ansar Ave,Koohbar Blvd,Zerehi
City
Shiraz
Province
Fars
Postal code
7184747811
Approval date
2020-10-26, 1399/08/05
Ethics committee reference number
IR.SUMS.MED.REC.1399.330
Health conditions studied
1
Description of health condition studied
Fibromyalgia
ICD-10 code
M79.7
ICD-10 code description
Fibromyalgia
Primary outcomes
1
Description
body pain
Timepoint
Before treatment-2-4-8 weeks later
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
functional status
Timepoint
Before treatment -2-4-8 weeks after treatment
Method of measurement
FIBROMYALGIA IMPACT QUESTIONNAIRE (FIQ )
Intervention groups
1
Description
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)
Category
Treatment - Drugs
2
Description
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.