Objectives: To assess the effect of small saphenous phlebotomy on pain due to sciatic neuropathy in patients with sciatic radicular pain Design: a randomized clinical trial. Setting and conduct: The eligible patients with sciatic radicular pain who will refer to a private clinic during the study period will be enrolled into the trial. Inclusion criteria: (a) having neuropathy; (b) having degenerative disorder in vertebral column; (c) age of 18 to 65 years. Exclusion criteria: (a) having inflammatory, infective, psychiatry, hemorrhagic disorders of malignancy; (b) not being candidate for surgery. Intervention: small saphenous phlebotomy in the area between the external malleolus and the achilles tendon for 10 to 20 ml plus non-steroidal anti-inflammatory drugs three times a day for one month. Control: non-steroidal anti-inflammatory drugs three times a day for one month. Primary outcome: measuring the radicular pain severity before and one month after intervention using Neuropathic Pain Questionnaire (NPQ) and Neuropathic Pain Scale (NPS). Secondary outcome: measuring inflammatory gen activity (IL-1β, IL-6, TNFR1, and TNF-α) before and one month after intervention using PCR
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501029014N51
Registration date:2015-01-07, 1393/10/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-07, 1393/10/17
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2015-01-21, 1393/11/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of small saphenous phlebotomy on pain due to sciatic neuropathy in patients with sciatic radicular pain: a randomized clinical trial
Public title
Effect of small saphenous phlebotomy on pain due to sciatic neuropathy in patients with sciatic radicular pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: (a) having neuropathy; (b) having degenerative disorder in vertebral column; (c) age of 18 to 65 years.
Exclusion criteria: (a) having inflammatory, infective, psychiatry, hemorrhagic disorders of malignancy; (b) not being candidate for surgery.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
230
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: random assignment of the patients systematically one at a time to intervention and control groups.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor of Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan
City
Hamadan
Postal code
6517838695
Approval date
2014-12-30, 1393/10/09
Ethics committee reference number
P/16/35/9/4973
Health conditions studied
1
Description of health condition studied
sciatic radicular pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
measuring the radicular pain severity
Timepoint
before and one month after intervention
Method of measurement
using Neuropathic Pain Questionnaire (NPQ) and Neuropathic Pain Scale (NPS).
Secondary outcomes
1
Description
measuring inflammatory gen activity (IL-1β, IL-6, TNFR1, and TNF-α)
Timepoint
before and one month after intervention
Method of measurement
Using PCR
Intervention groups
1
Description
small saphenous phlebotomy in the area between the external malleolus and the achilles tendon for 10 to 20 ml plus non-steroidal anti-inflammatory drugs three times a day for one month
Category
Treatment - Surgery
2
Description
non-steroidal anti-inflammatory drugs three times a day for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
A Private clinic
Full name of responsible person
Dr Hossein Mirzaei
Street address
A Private clinic, Rokni Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Non gvermental
Full name of responsible person
Dr Hossein Mirzaei
Position
General Pgysician
Other areas of specialty/work
Street address
A Private clinic, Rokni Ave.
City
Hamadan
Postal code
Phone
+98 81 3823 0212
Fax
Email
drhosseinmirzaei@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Non govermental
Full name of responsible person
Dr Hossein Mirzaei
Position
General Pgysician
Other areas of specialty/work
Street address
A Private clinic, Rokni Ave.
City
Hamadan
Postal code
Phone
+98 81 3823 0212
Fax
Email
drhosseinmirzaei@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)