The effect of acupuncture on the pain of patients with acute low back pain referring to the emergency department.
Design
Two arm parallel group randomized trial and outcome assessment
Settings and conduct
In this study, patients with patient satisfaction before randomization in this way, patients from studying Emam Reza Hospital of Mashhad Emergency Hospital are selected by sampling if they have entry requirements and personal satisfaction. The selection of individuals to the intervention and control group will be randomized with the help of numbers in sealed envelopes. In this case, envelopes will be provided to the number of participants and arranged in each group with the help of random numbers in each envelope. To be With the arrival of patients, the relevant envelope is opened and the patient group is identified. Patients are divided into two equal groups of NSAID recipients who are taking ibuprofen 600 mg four times a day for two weeks and another being treated with ankle-acupuncture with ibuprofen.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 25 to 55 years old
Exclusion criteria: pregnancy
With trauma
Disability
Acute low back pain with red flags: history of cancer, risk factors of cancer, abnormal Physical nerve examination, Evidence of infection such as fever, Intravenous drug users, Recent bacterial infection, Immunodeficiency, Embedding the inside of the spinal
Lower back pain for more than six weeks
Contraindication to receive NSAIDs
Intervention groups
The control group consisted of forty patients who receive the usual drug treatment.
The intervention group 2 consists of forty patients who receive interventional acupuncture supplementation.
Main outcome variables
The pain rate of patients at the moment of entry and two hours later and the next day after acupuncture.
Patient pain rate at the time of entry and two weeks after ibuprofen treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190521043662N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Payman Delavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3821 6646
Email address
delavarp941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-10, 1396/10/20
Expected recruitment end date
2019-02-06, 1397/11/17
Actual recruitment start date
2018-01-10, 1396/10/20
Actual recruitment end date
2019-02-06, 1397/11/17
Trial completion date
2019-04-15, 1398/01/26
Scientific title
The effect of acupuncture supplement on the pain of patients with acute low back pain referring to the emergency department
Public title
Effect of acupuncture in low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with acute low back pain referring to the emergency department
Exclusion criteria:
Age less than 25
Age over 55
Age
From 25 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation to the intervention and control group by the random allocation method with help of numbers in sealed envelopes. acupuncture in a group is added to the standard treatment of a specified dose of ibuprofen.
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 Mashhad University of Medical Sciences
Street address
Namaz 11
City
Mashhad
Province
Razavi Khorasan
Postal code
917 735 6993
Approval date
2018-02-28, 1396/12/09
Ethics committee reference number
Ir.mums.fm.rec.1396.784 که به ایمیل admin ارسال شده است
Health conditions studied
1
Description of health condition studied
Acute low back pain
ICD-10 code
M00-M99
ICD-10 code description
بیماریهای سیستم اسکلتی عضلانی و بافت همبند
Primary outcomes
1
Description
Pain score
Timepoint
The moment of arrival (zero hour) and two hours later (2 hours) and the day (24 hours) after acupuncture in forty patients and Patient pain at the time of entry and two weeks after treatment with ibuprofen in forty patients.
Method of measurement
Numeric rating scale questionare
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The effect of an ankle acupuncture treatment Comes with Ibuprofen.
Category
Treatment - Other
2
Description
Control group: Ibuprofen drug recipients
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Payman.Delavar
Street address
Namaz 11
City
Mashhad
Province
Razavi Khorasan
Postal code
917 735 6993
Phone
+98 51 3821 6646
Email
Paydelavar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ehsab.Bolverdi
Street address
Saberi Blvd, Imam reza hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
917 735 6993
Phone
+98 51 3852 5312
Fax
+98 51 3852 5312
Email
Bolvardie@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?