This study is a non-randomized clinical trial with parallel control group that conducted in cupping clinic and private office of a neurologist in Shahroud city, Iran. Early-stage sampling will be from July 2009 to late January 2011 that 45 patients enrolled in the study. The target population is patients with primary headache. Sampling is purposive, and assignment to two groups (drug therapy and leech therapy) was non- random. Inclusion criterion: diagnosis of primary headache by neurologist based on diagnostic parameters. Major exclusion criteria: patients with brain tumors and other brain diseases; patients with hemorrhagic disorders .
Objective: To determine and compare the intensity and duration of headache in patients with primary headaches before and after leech therapy and drug therapy.
Methods: In leech therapy group, the severity and duration of the patient’s headache were recorded and then 1-3 leeches were placed behind the patient's ear according to the physician‘s order. The session of leech therapy lasted about 50-30 minutes. Drug therapy group were patients with symptoms of headache who referred to neurologist and after documentation of the severity and duration of headache were discharged with medication. Patients in this group used one of medication regimens for primary headaches that mainly included a combination of propranolol 40 mg twice a day, nortriptyline 25 mg twice a day, or citalopram 20 mg daily used for 3 months. After first visit, the severity and duration of patients’ headache in two groups were followed up for 3 months.The instruments for data collection included forms for demographic characteristics, Visual Analogue Scale for measuring severity of headache, and checklists designed for following up and documentation of severity and duration of patients’ headache and drug consumption.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014032717090N1
Registration date:2014-06-07, 1393/03/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-06-07, 1393/03/17
Registrant information
Name
Mahmoud Bakhshi
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1859 1511
Email address
bakhshim881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Islamic Azad University of Sharoud
Expected recruitment start date
2009-06-24, 1388/04/03
Expected recruitment end date
2011-01-18, 1389/10/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of leech therapy on primary headache in patients referring to Cupping unit
Public title
The effect of leechtherapy on headache
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: diagnosis of primary headache by neurologist based on diagnostic parametres.
Exclusion criteria: patients with brain tumors and other brain diseases; patients with sinusitis and anemia (Hb<10 g/dl); pregnant or breastfeeding women; patients with hemorrhagic disorders ; using anticoagulant drugs ; patients with acute medical conditions such as cardiac, renal and hepatic diseases.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not 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
Ethics Committee of Islamic Azad University of Shahroud
Street address
Beside Police Station, after traveling terminal
City
Shahroud
Postal code
Approval date
2009-04-14, 1388/01/25
Ethics committee reference number
88/088
Health conditions studied
1
Description of health condition studied
Primary headache
ICD-10 code
G43, G44
ICD-10 code description
Migraine, other headache syndromes
Primary outcomes
1
Description
Severity of headache
Timepoint
Before and after intervention at first week , first month, second month and third month subsequently
Method of measurement
visual analogue scale
2
Description
duration of headache
Timepoint
Before and after intervention at first week , first month, second month and third month subsequently
Method of measurement
time by hours in day
Secondary outcomes
1
Description
duration of disease
Timepoint
First visit
Method of measurement
interview
2
Description
drug consumption
Timepoint
Before and after intervention at first week , first month, second month and third month subsequently
Method of measurement
self-reporting
Intervention groups
1
Description
Leech therapy:1-3 leeches were placed behind the patient s ear. Each session lasted approximately 30-50 minutes. in average, each patient undertook leechtherapy, 1 to 3 session every 3 weeks.
Category
Other
2
Description
Drug therapy (propranolol 40 mg, Nortriptyline 50 mg or citalopram 20 mg)daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Cupping Center
Full name of responsible person
Mr Hossein Taheri
Street address
Opposite Traffic office, Tehran Avenue
City
Shahroud
2
Recruitment center
Name of recruitment center
Private Office
Full name of responsible person
Dr Babak Jalalian
Street address
Bahar medical building, 22 Bahman Avenue
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancelor for research of Islamic Azad University of Shahroud
Full name of responsible person
Dr Behzad Chahcandi
Street address
Islamic Azad University, Shahroud
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancelor for research of Islamic Azad University of Shahroud
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
Islamic Azad University of Shahroud
Full name of responsible person
Mr Mahmoud Bakhshi
Position
Faculty member
Other areas of specialty/work
Street address
Nursing faculty, Islamic Azad University, Shahroud
City
Shahroud
Postal code
Phone
+98 27 3339 4342
Fax
Email
bakhshi_mahmoud@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Mr Mahmoud Bakhshi
Position
Master of Science
Other areas of specialty/work
Street address
Islamic Azad University, Shahroud
City
Shahroud
Postal code
Phone
+98 27 3339 4342
Fax
Email
bakhshi_mahmoud@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic azad university of Shahroud
Full name of responsible person
Mr Mahmoud Bakhshi
Position
Master of science
Other areas of specialty/work
Street address
No 39, Shaghayegh Avenue, Novin suburb
City
Shahroud
Postal code
Phone
Fax
Email
bakhshim881@mums.ac.ir; bakhshi_mahmoud@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)