Objectives of the study:
An investigation on the effect of acupuncture on the symptoms of patients infected with HTLV-1 associated myelopathy (HAM) / tropical spastic Paraparesis (TSP).
The main outcome variables include spastic paraparesis, urinary incontinence, back pain, disability, and peripheral blood viral load.
Intervention:
In this study, the intervention is semi-experimental with pretest and posttest measure design. The patients will be neurologically examined in clinic and their peripheral blood samples will be evaluated for detection of viral load. Subsequently, the patients will receive acupuncture treatment three sessions a week for four weeks. The patients will be neurologically reexamined and for the second time the blood viral loads will be measured immediately after the intervention. Then, the same evaluation is planned to be performed three months after initial therapy using the described criteria.
Inclusion criteria:
Informed consent, and confirmation of HAM / TSP according to World Health Organization (WHO) criteria
Exclusion criteria:
Patients who have contraindications for acupuncture such as wound or skin infection at the time of acupuncture therapy or bleeding diathesis; patients who suffer from other illness that may exacerbate the paraparesis such as vitamin B12 deficiency.
The intervention is acupuncture.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031327036N1
Registration date:2017-05-05, 1396/02/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-05-05, 1396/02/15
Registrant information
Name
Amirali Ghahremani
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2648
Email address
ghahremaniaa921@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Mashhad university of medical sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of acupuncture in the control of patients’ symptoms with HTLV1 Associated Myelopathy/Tropical Spastic Paraparesis (HAM/TSP(
Public title
efficacy of acupuncture on symptoms of htlv1 patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent, and confirmation of HAM / TSP according to World Health Organization (WHO) criteria
Exclusion criteria:
Patients who have contraindications for acupuncture such as wound or skin infection at the time of acupuncture therapy or bleeding diathesis; patients who suffer from other illness that may exacerbate the paraparesis such as vitamin B12 deficiency.
The intervention is acupuncture.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Township health knowledge, Fakury boulevard,Mashhad University of Medical Sciences, Mashhad, Iran
Before the intervention and After the intervention then three months after the intervention.
Method of measurement
on basis of Criterion ashworth
2
Description
incontinency
Timepoint
Before the intervention and After the intervention then three months after the intervention.
Method of measurement
on basis of Criterion ICIQ-SF
3
Description
back pain
Timepoint
Before the intervention and After the intervention then three months after the intervention.
Method of measurement
on basis of Criterion VAS
4
Description
Disability
Timepoint
Before the intervention and After the intervention then three months after the intervention.
Method of measurement
on basis of Criterion OMDS
5
Description
viral load
Timepoint
Before the intervention After the intervention, three months after the intervention.
Method of measurement
DNA copy number of virus per mononuclear cells
Secondary outcomes
1
Description
-
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention:
In this study, the intervention is semi-experimental with pretest and posttest measure design. The patients will be neurologically examined in clinic and their peripheral blood samples will be evaluated for detection of viral load. Subsequently, the patients will receive acupuncture treatment three sessions a week for four weeks. The patients will be neurologically reexamined and for the second time the blood viral loads will be measured immediately after the intervention. Then, the same evaluation is planned to be performed three months after initial therapy using the described criteria.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Ghaem Hospital
Full name of responsible person
Dr Amirali Ghahremani
Street address
Ghaem Hospital, Dr. Shariati Square, beginning of Ahmadabad Avenue, Mashhad-Iran,
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Mashhad university of medical sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran
City
Mashahd
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,Mashhad 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
Mashahd university of medical
Full name of responsible person
Dr Amirali Ghahremani
Position
Resident of Neurology
Other areas of specialty/work
Street address
Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran
City
Mashhad
Postal code
99191-91778
Phone
+98 51 38049
Fax
+98 38453239
Email
ghahremaniaa921@mums.ac.ir؛ shoeibia@gmail.com
Web page address
http://mums.ac.ir/newmums/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of medical
Full name of responsible person
Dr Ali Shoeibi
Position
Associate Professor of neurology
Other areas of specialty/work
Street address
Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran
City
Mashhad
Postal code
9919191778
Phone
+98 51 38049
Fax
+98 51 3845 3239
Email
shoeibia@mums.ac.ir؛ shoeibia@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad university of medical
Full name of responsible person
Dr Amirali Ghahremani
Position
Resident of Neurology
Other areas of specialty/work
Street address
Knowledge and Health City,In the end of Shahid Fakouri Blvd, Mashhad,Iran