Protocol summary

Summary
Multiple sclerosis (MS) is a chronic, progressive neurological disease that results in a set of environmental factors, genetic and autoimmune occurs. This study investigated the effect of acupressure in reducing fatigue and pain that patients with MS. METHODS: A sample of 100 women (18-40 years) of the MS Society in Tehran have inclusion criteria (female, they have a week of pain, fatigue are mentioned, the use of lack of acupressure) are selected. Patients randomized in the acupressure group (n = 50) and controls (n = 50). Pain is measured with visual analog scale and fatigue is measured with FSS questionnaire.Interventions in this study is to educate patients for intervention.In groups of three points LI4, SP6, ST36, each for two minutes on each side of the body three times a day for two weeks to do by themselves. In control group instead of just pushing the points they are touched.The FSS questionnaire and visual analog scale of pain completed once before the first intervention, immediately after the intervention, two weeks and four weeks after they completed the intervention. Patients who do not want to do and don't a quarter days are excluded.

General information

Acronym
multiple sclerosis(MS)
IRCT registration information
IRCT registration number: IRCT201108276247N2
Registration date: 2011-08-29, 1390/06/07
Registration timing: prospective

Last update:
Update count: 0
Registration date
2011-08-29, 1390/06/07
Registrant information
Name
Farideh Bastani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8857 2278
Email address
f-bastani@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nursing Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2011-09-01, 1390/06/10
Expected recruitment end date
2011-12-01, 1390/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of acupressure on severity of fatigue and pain of multiple sclerosis patients.
Public title
The Effect of Acupressure on Severity of Fatigue and Pain of Multiple Sclerosis (MS) disease in female members of MS Association.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with stable vital signs; lack of wounds and deformity in the LI4( When the thumb is in full extension, the middle point of the angle between the first and second metacarpal), ST36(The width of a finger tip to the side with the lower edge of the tibia 3 cun below the knee), SP6(or sanyingiao 3 cun above the inner ankle to the back edge of the posterior tibia); being able to read and write; confirmed fatigue related to MS; no history of using acupressure; no history of smoking, using drugs or pills; age between18-40 and EDSS is between 0-5.5. Exclusion criteria: unwillingness to continue participation in the trial; complications during the procedure; known physical and mental disorders; being perform the acupressure point 4LI, ST36, SP6 and don't have any sense of warmth, heaviness, swelling or numbness and not performing more than a quarter of days.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
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, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2011-07-25, 1390/05/03
Ethics committee reference number
13783

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
Pain reduction
Timepoint
Before the intervention, immediately after, two weeks after the first two weeks after the last intervention
Method of measurement
Visual analog scale

2

Description
Fatigue reduction
Timepoint
Before the intervention, immediately after, two weeks after the first two weeks after the last intervention
Method of measurement
Fatigue Severity Scale

Secondary outcomes

1

Description
Severity of pain
Timepoint
Before the intervention, immediately after, two weeks after the intervention and four weeks after the first intervention
Method of measurement
Visual analog scale

2

Description
Severity of fatigue
Timepoint
Before the intervention, immediately after, two weeks after the intervention and four weeks after the first intervention
Method of measurement
Fatigue Severity Scale

Intervention groups

1

Description
Patients in the intervention group or individual instruction for acupressure points (LI4, SP6, ST36) for two minutes on each side, three times a day for two weeks
Category
Treatment - Other

2

Description
Control group: same the intervention group rather than just do the palpation.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Society in Tehran
Full name of responsible person
Dr.Allaie
Street address
No. 35, Shams St., Taleghani Avenue, Vesal Shirazi street, Enqelab Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz 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, School of Nursing and Midwifery
Full name of responsible person
Dr.Farideh Bastani
Position
Associate Professor
Other areas of specialty/work
Street address
School of Nursing,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
f-bastani@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Farideh Bastani
Position
PhD
Other areas of specialty/work
Street address
School of Nursing,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
f-bastani@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzyieh Sobhani
Position
Graduate Nursing Student
Other areas of specialty/work
Street address
School of Nursing,Tohid Square
City
Tehran
Postal code
Phone
+98 21 6692 2700
Fax
Email
m-sobhani@razi.tums.ac.ir
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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