1. Home
  2. Approved trials
  3. » فارسی

The study of effectiveness of dry Cupping Therapy on fatigue and quality of life in patients with Multiple Sclerosis

Protocol summary

Study aim
Determine of the effect of dry Cupping Therapy on fatigue and quality of life in patients with Multiple Sclerosis
Design
This study is a clinical trial with two groups (intervention and control), single blinded (the data analyst) and randomized, with 30 patients in each group.
Settings and conduct
This single blinded study (the data analyst), will be done in the Kerman Medical Center of the Special Diseases. In the intervention group, 8 sessions of dry Cupping Therapy will be performed. The variables will be measured before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ability to communicate in Persian language, diagnosis of Multiple Sclerosis according to neurologist confirmation, the severity of mental fatigue at the beginning of the research on the Fatigue Severity Scale (FSS) is equal to or greater than thirty six, the absence of chronic diseases and other conditions that affect the fatigue and quality of life of people, such as diabetes, cancer, etc, Not having surgery for the last six months, abnormal wound and redness from the scapula to the waist. Exclusion criteria: Use of anticoagulants, coagulopathy, getting severe psychological disorders that are inappropriate for participation in this study, a change in the course of the disease that causes the patient to be hospitalized, failure to follow the Dry Cupping Therapy program by the patient for any reason and some cases of recurrence of symptoms during the intervention so that it can affect our intervention.
Intervention groups
In the intervention group, 8 sessions of Dry Cupping Therapy will be performed in 4 weeks and two sessions per week, While patients in the control group will receive routine fatigue reduction methods. The severity of fatigue and the quality of life score will be measured before and after the intervention.
Main outcome variables
fatigue and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151107024919N8
Registration date: 2019-07-06, 1398/04/15
Registration timing: prospective

Last update: 2019-07-06, 1398/04/15
Update count: 0
Registration date
2019-07-06, 1398/04/15
Registrant information
Name
Batoul Tirgari
Name of organization / entity
Kerman Medical University of Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3132 5207
Email address
b_tirgari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-23, 1398/05/01
Expected recruitment end date
2019-09-06, 1398/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of effectiveness of dry Cupping Therapy on fatigue and quality of life in patients with Multiple Sclerosis
Public title
Effect of dry Cupping on fatigue and quality of life in patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to communicate in Persian language. Diagnosis of Multiple Sclerosis according to neurologist confirmation. The severity of mental fatigue at the beginning of the research on the Fatigue Severity Scale (FSS) is equal to or greater than thirty six. The absence of chronic diseases and other conditions that affect the fatigue and quality of life of people, such as diabetes, cancer, etc. Not having surgery for the last six months, abnormal wound and redness from the scapula to the waist.
Exclusion criteria:
Use of anticoagulants coagulopathy Getting severe psychological disorders that are inappropriate for participation in this study A change in the course of the disease that causes the patient to be hospitalized Failure to follow the Dry Cupping Therapy program by the patient for any reason Some cases of recurrence of symptoms during the intervention so that it can affect our intervention
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In order to allocate the subjects to the intervention and control groups, a randomized classification method is used, so that people in terms of severity of fatigue, quality of life score, drug use by patients, type of disease, duration of illness, etc. are divided into groups. Subsequently, through the use of a simple method and using Excel software from each group, half of the subjects are placed in the intervention group and the other half are in the control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst does not know which data is related to the intervention group and which data is related to the control group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Medical Center of the Special Diseases, No. 78 Alley, Shahid Rajaee Street,
City
kerman
Province
Kerman
Postal code
7619875994
Approval date
2019-06-24, 1398/04/03
Ethics committee reference number
IR.KMU.REC.1398.168

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Fatigue severity
Timepoint
The severity of fatigue will be measured before and after the intervention at the end of the fourth week.
Method of measurement
Fatigue Severity Scale

2

Description
Quality of Life
Timepoint
The quality of life score will be measured before and after the intervention at the end of the fourth week.
Method of measurement
Multiple Sclerosis Quality of Life- 54 Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the intervention group, 8 sessions of dry Cupping therapy will be performed in 4 weeks and two sessions per week, on Saturday and Tuesday. The intervention will be carried out by the researcher and for this purpose. First, from the scapular to the waist, with 4 to 5 drops of Noshad branded chamomile oil, massage will be carried out for 3 to 4 minutes. Then the Cold dry Cupping, using silicone cups, which can be 6 to 10 numbers depending on the person's body, on the site (on the sides of the spine, around the inter-vertebral line, from the scapula to the waist) will be done.
Category
Other

2

Description
Control group: Patients in the control group receive received routine fatigue reduction methods such as exercise, relaxation techniques, etc..
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical Center of the Special Diseases
Full name of responsible person
Batool Tirgari
Street address
Medical Center of the Special Diseases, No. 78 Alley, Shahid Rajaee Street,
City
Kerman
Province
Kerman
Postal code
7619875994
Phone
+98 34 3271 2001
Fax
+98 34 3271 2127
Email
b_tirgari@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/snm

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhti
Street address
No 2, Research and Technology Dept., Ibnsina Ave., Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3121 7213
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa/vcrt
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
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
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft- Bagh- Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Batool Tirgari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft-Bagh-Alavi Highway, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5207
Fax
+98 34 3132 5184
Email
b_tirgari@kmu.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
Not applicable
Loading...