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The effect of Basilic phlebotomy on sciatalgia and its comparison with classical medical treatment

Protocol summary

Study aim
The effect of Basilic phlebotomy on sciatalgia and its comparison with classical medical treatment
Design
Clinical practice Patients were randomly assigned to each other in two groups of control and case respectively   Are included. One blind spot   The two groups did not have any other knowledge of the other group Projected sample size: 50
Settings and conduct
Patients with Sciatic pain requiring non-surgical treatment referred to the health center of Shahed University of Medical Sciences were selected randomly and one blinded.   A group of 100 and the second group are treated with diclofenac tablets
Participants/Inclusion and exclusion criteria
Sciatica pain requires non-surgical treatment Major reasons for not entering the study before randomization  35> BMI> 18 Fixed weight The desire to participate in a patient's study There is no history of surgical dislocations of the spine and severe sensory and motor pain Inflammatory back pain, rheumatism, ganglion and metabolic disorders, bad breaths, blood diseases and coagulation diseases, and pelvic abnormalities due to CDH or other spinal diseases such as scoliosis, kyphosis, spondylolisthesis, etc. Do not have anemia Not being treated with morphine or drug addiction Pregnant or lactating women. There is no history of fracture or surgery in the last three months. There is no history of any inflammatory disease of the joints, such as rheumatoid arthritis, rheumatic fever, and ankylosing spondylitis. The patient should not be cold and dry in a less than warm, dry environment No significant mental illness (such as schizophrenia). Do not stop taking Diclofenac tablets Not being treated with anticoagulants
Intervention groups
Sciatica pain requires non-surgical treatment
Main outcome variables
Evaluation of pain intensity in the two groups and their comparison before and after the study Evaluation of patients' quality of life in two groups and their comparison before and after study Assessing the disability of patients in two groups and comparing them before and after study

General information

Reason for update
Acronym
Fasd
IRCT registration information
IRCT registration number: IRCT20180131038575N1
Registration date: 2018-02-27, 1396/12/08
Registration timing: registered_while_recruiting

Last update: 2018-02-27, 1396/12/08
Update count: 0
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
Mohammad Hasan Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3225 3374
Email address
mhassan.amini@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-20, 1396/12/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Basilic phlebotomy on sciatalgia and its comparison with classical medical treatment
Public title
The effect of Basilic phlebotomy on sciatalgia and its comparison with classical medical treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sciatica pain requires non-surgical treatment 35 > BMI >18 Fixed weight The desire to participate in a patient's study There is no history of surgical dislocations of the spine and severe sensory and motor pain Inflammatory back pain, rheumatism, ganglion and metabolic disorders, bad breaths, blood diseases and coagulation diseases, and pelvic abnormalities due to CDH or other spinal diseases such as scoliosis, kyphosis, spondylolisthesis, etc. Do not have anemia Not being treated with morphine or drug addiction Pregnant or lactating women. There is no history of fracture or surgery in the last three months. There is no history of any inflammatory disease of the joints, such as rheumatoid arthritis, rheumatic fever, and ankylosing spondylitis. The patient should not be cold and dry in a less than warm, dry environment No significant mental illness (such as schizophrenia). Do not stop taking Diclofenac tablets Not being treated with anticoagulants
Exclusion criteria:
Possible side effects of treatment Unwillingness to continue to participate in the plan. Irreparable aggravation of pain and disability.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly assigned to each other in two groups of control and case respectively Are included.
Blinding (investigator's opinion)
Single blinded
Blinding description
The two groups did not have any other knowledge of the other group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahed University
Street address
University of Shahed University، facing the shrine Imam Khomeini، Persian Gulf Highway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
IR.Shahed.REC.1396.27

Health conditions studied

1

Description of health condition studied
Sciatica pain
ICD-10 code
M00-M99
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue

Primary outcomes

1

Description
Intensity of pain
Timepoint
Before, one day, three days, ten days and four weeks after the scheduled time
Method of measurement
VAS questionnaire

Secondary outcomes

1

Description
Quality of Life
Timepoint
Before the start of the project and one month later (the end of the project)
Method of measurement
SF36 questionnaire

2

Description
Disability
Timepoint
Before the start of the project and one month later (the end of the project)
Method of measurement
Ronaldomiris questionnaire

3

Description
Generic temper
Timepoint
Before the start of the project and one month later (the end of the project)
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: phlebotomy
Category
Treatment - Other

2

Description
Control group: Taking 50 to 100 mg of diclofenac tablets based on patient weight (less than 60 kg), Alborz Medication will be placed twice a day for 7 to 10 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Traditional Medicine, Shahed University
Full name of responsible person
Mohammad Hasan Amini
Street address
No. 17، Arman Avenue، Dashtestan 3 Ave، Below Hoseinieh Ershad، Dr. Shariati Avenue، Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 2288 2596
Email
hasanamini78@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Zahra Kyasalari
Street address
University of Shahed University، facing the shrine Imam Khomeini، Persian Gulf Highway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Fax
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mohammad Hasan Amini
Position
Assistant Specialist in Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
University of Shahed University، facing the shrine Imam Khomeini، Persian Gulf Highway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 51210
Email
mhassan.amini@shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Seyyed Saeed Esmaeili Saber
Position
Iranian medicine specialist
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
University of Shahed University، facing the shrine Imam Khomeini، Persian Gulf Highway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 51210
Email
mhassan.amini@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mohammad hasan Amini
Position
Assistant Specialist in Iranian Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
University of Shahed University، facing the shrine Imam Khomeini، Persian Gulf Highway, Tehran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 51210
Email
mhassan.amini@shahed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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