Evaluation of different methods of acupuncture in the treatment of low back pain
Design
In this study, 30 patients with low back pain who have been referred by orthopedic surgeon or neurosurgeon to the clinic of Ghaem hospital, are selected. Participants are divided into two treatment groups using a computer program that select an odd or even number.
Settings and conduct
Background: Low back pain is one of the problems of civilized life, and many people of different ages tend to suffer from this disease, in which case the patients will suffer not only a lot of suffering, but also his work and his everyday life and affection. On the other hand, various studies have shown that acupuncture has a significant effect on reducing the pain and suffering of the patient.
Place: Qaem Hospital, Acupuncture Section
In two groups of 15, in one group, acupuncture is administered by injecting vitamin B and in the other without vitamin B injection.
Participants/Inclusion and exclusion criteria
Patients are selected from both sexes; Non drug use; Age between 18 and 60 years; No cardiovascular disease; No diabetic disease.
Exclusion Criteria: Pregnancy; Breastfeeding; Cardiovascular diseases; Older than 18 years old; High Blood Pressure; The presence of illness-induced severe illness; There is a backache other than stretch or disco-pathetic.
Intervention groups
The first group consists of 15 patients with low back pain which in the standard acupuncture points; the needle will be pulled and then attached to an electro acupuncture device for 20 minutes. This treatment will last 3 times a week and a total of 12 sessions of 20 minutes.
The second group consists of 15 patients with low back pain who will undergo small injections of vitamin B in amount of one tenth of the cc in the standard acupuncture points and this treatment will last 3 times a week and a total of 12 sessions which this action will be based on Chinese medicine references.
Main outcome variables
low back pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171017036839N3
Registration date:2018-02-11, 1396/11/22
Registration timing:retrospective
Last update:2018-02-11, 1396/11/22
Update count:0
Registration date
2018-02-11, 1396/11/22
Registrant information
Name
Hamid Abdi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 8931
Email address
abdih1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Mashhad University of Medical Sciences.
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-21, 1396/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of classical acupuncture and injection acupuncture on similar points on reducing pain in discopathy low back pain.
Public title
Comparing the Worth of Using the Needle or Micro Injection in Similar Acupoints in Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are selected from both sexes
No drug use
Age between 18 and 60 years
No cardiovascular disease
No diabetic disease
Exclusion criteria:
Pregnancy
Breastfeeding
Cardiovascular diseases
Older than 18 years old
High Blood Pressure
The presence of illness-induced severe illness
There is a backache other than stretch or disco-pathetic
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided into two treatment groups using a computer program that select an odd or even number.
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
Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.MUMS.REC.1396.188
Health conditions studied
1
Description of health condition studied
Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Back Pain
Timepoint
Before and after the intervention.
Method of measurement
Questionnaire
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
2
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
consists of 15 patients with low back pain who will undergo small injections of vitamin B in amount of one tenth of the cc in the standard acupuncture points.
Category
Treatment - Drugs
2
Description
The first group consists of 15 patients with low back pain which in the standard acupuncture points; the needle will be pulled and then attached to an electro acupuncture device for 20 minutes. This treatment will last 3 times a week and a total of 12 ses
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Acupuncture Clinic, Special Clinic, Ghaem Hospital
Full name of responsible person
Hamid Abdi
Street address
Ahmadabad St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3801 2490
Email
abdih1@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghodi
Street address
Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Email
Ramresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamid Abdi
Position
PhD in Acupuncture
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3884 8931
Fax
Email
abdih1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Hamid Abdi
Position
PhD in Acupuncture
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3884 8931
Fax
Email
abdih1@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Abdi
Position
Researcher
Latest degree
Bachelor
Other areas of specialty/work
researcher
Street address
Administration Center (Qoreishi Building), Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
9176699199
Phone
+98 51 3802 2632
Fax
Email
abdis1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only the possibility of sharing information about the main consequence exists
When the data will become available and for how long
At the end of the project
To whom data/document is available
Research leader and colleagues and related organizations such as Mashhad University of Medical Sciences
Under which criteria data/document could be used
Currently, except for the implementer and its colleagues, individuals and institutions do not have permission to use new analysis on the data.
From where data/document is obtainable
The data is available to the research leader
What processes are involved for a request to access data/document
It will only be possible to use data in coordination with the research leader