Protocol summary

Summary
The aim of this study was to compare the effect of diclofenac and phlebotomy of Al-nesa vein on the pain spread to the lower extremities. Patients with complaints of pains spread to lower extremities were enrolled in this study. Inclusion criteria included age 20 to 60 years, mechanical low back pain, a herniated disc between the vertebrae (including sciatic pain), osteoarthritis, spinal stenosis, spinal fractures, bad sit, scoliosis. Exclusion criteria included surgery for low back pain, infection, rheumatism, endocrine or metabolic-induced low back pain, tumors, hematologic diseases, mental illnesses, coagulation disease, surgery indication, referral pain from other organs, abnormal severity of pain, patient dissatisfaction, a history of faint subsequent to phlebotomy or wet cupping, contraindications of phlebotomy, BMI over 35. Patients will be randomly assigned in to two groups. The control group treated with diclofenac 100 mg (Albrzdaru company ) for two weeks. Study group is treated with phlebotomy of "Al-nesa" vein.The used bistury blade is NO. 11, induced gap is 1-2 mm, volume of taken blood is 100-150 cc. The questionnaires including personal information and history of diseases, VAS, quality of life and standard of Roland Morris. The questionnaires are filled before treatment, two week, and one month after treatment. At the end of the study the results obtained from both groups are compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015101724557N1
Registration date: 2015-11-16, 1394/08/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-11-16, 1394/08/25
Registrant information
Name
Mohamad Reza Morovati
Name of organization / entity
Tehran university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 83 3722 7104
Email address
mreza13461346@yahoo.com
Recruitment status
Recruitment complete
Funding source
Tehran university of medical sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-01-21, 1394/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of phlebotomy of "Al-Nesa" vein with diclofenac on the pain spread to the lower extremities
Public title
Effect of phlebotomy on the pain spread to the lower extremities
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 20 to 60 years old; mechanical low back pain: a herniated disc between the vertebrae (including sciatic pain); osteoarthritis; spinal stenosis; spinal fractures; bad sit; scoliosis. Exclusion criteria: surgery for low back pain; infection; rheumatism; endocrine or metabolic-induced low back pain; tumors; hematologic diseases; mental illnesses; coagulation disease; surgery indication; referral pain from other organs; abnormal severity of pain; patient dissatisfaction; a history of faint subsequent to phlebotomy or wet cupping; contraindications of phlebotomy; BMI over 35.
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv.
City
Tehran
Postal code
Approval date
2015-09-24, 1394/07/02
Ethics committee reference number
IR.TUMS. REC.1394

Health conditions studied

1

Description of health condition studied
Pain radiating into the lower extermity (sciatica)
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
low back pain
Timepoint
Baseline and two months later
Method of measurement
Wu Roland Morris questionnaire using VAS scale

Secondary outcomes

1

Description
Failure
Timepoint
Baseline and two months later
Method of measurement
Quality of life and standard questionnaire of Roland Morris

Intervention groups

1

Description
Phlebotomy group: phlebotomy "Al-nesa" vein on the lateral malleolus
Category
Treatment - Surgery

2

Description
Control group Tablets Alfen XL (diclofenac 100 mg) Alborz drug, twice a day
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kermanshah University of Medical Sciences' Clinic
Full name of responsible person
Street address
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Reza Morovati
Street address
Tehran University of Medical Sciences, Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Reza Morovati
Position
MD, Assistant traditional medicine
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 83 3722 7104
Fax
Email
mreza13461346@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohamad Reza Morovati
Position
MD, Assistant traditional medicine
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Postal code
Phone
+98 83 3722 7104
Fax
Email
mreza13461346@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohamad Hossein Farzai
Position
Assistant Professor
Other areas of specialty/work
Street address
School of Pharmacy, Kermanshah
City
kermanshah
Postal code
Phone
Fax
Email
mh.farzaei@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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