Aim: This study aim is to investigate the effect of massage therapy on fatigue in patients with multiple sclerosis in Samenolhojaj Special diseases center of Kerman City.
Design: Clinical trial with random allocation of patients in case and control groups
Participants: 80 patients with Multiple Sclerosis are introduced to the study based on the inclusions and exclusions criteria. Main inclusion criteria are no history of massage therapy, score of 36 and higher with fatigue severity scale and disease duration of more than six months. Main exclusion criteria are affliction with other physical and mental disorders and increase the severity of MS during the study.
Intervention: Patients in intervention group will receive massage therapy and the control group receive usual care of treatment center.
Outcome: Evaluation of fatigue severity score and the effectiveness of massage therapy, before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201611217844N11
Registration date:2017-09-03, 1396/06/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-03, 1396/06/12
Registrant information
Name
Mansour Arab
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1320 5179
Email address
marab@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kerman University of Medical Sciences
Expected recruitment start date
2013-05-22, 1392/03/01
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigate the effect of massage therapy on fatigue in patients with Multiple Sclerosis (MS)
Public title
The effect of massage therapy on fatigue of patients with Multiple Sclerosis (MS)
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: No history of massage therapy; Score of 36 and higher with fatigue severity scale; Disease duration of more than six months
Main exclusion criteria: Affliction with other physical and mental disorders; Increase the severity of MS during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The random allocation method is roll of a dice
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Science
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
Postal code
Approval date
2013-04-06, 1392/01/17
Ethics committee reference number
k/92/487
Health conditions studied
1
Description of health condition studied
Fatigue
ICD-10 code
R53
ICD-10 code description
Malaise and fatigue
Primary outcomes
1
Description
Fatigue severity
Timepoint
Before and after of massage therapy
Method of measurement
Fatigue Severity Scale
Secondary outcomes
1
Description
The effectiveness of massage therapy
Timepoint
Before and after of each massage therapy session
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Patients in intervention group received massage therapy. Masseur is a family member who is trained by a physiotherapist.
Massage therapy sessions are provided for 20 minutes, 3 times a week, over a period of four weeks.
Category
Other
2
Description
Patients in the control group received usual care of treatment center
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Samenolhojaj Special Diseases Center of Kerman City
Full name of responsible person
Mr Ganjali Khani
Street address
Samenolhojaj Special Diseases Center, Shahid Rajaee St, Qaem Crossroads, Shariaati St, Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kerman University of Medical Sciences
Full name of responsible person
Dr Malek Pour Afshar
Street address
Vice chancellor for research, Kerman University of Medical Sciences, Jahad Blvd, Somayye Crossroads, Shariaati St, Kerman
City
Kerman
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 of Kerman 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
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 3132 5000
Fax
Email
marab112004@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
Razi Nursing and Midwifery School, Haft Bagh Alavi Highway, Kerman
City
Kerman
Postal code
Phone
+98 34 3132 5000
Fax
Email
marab112004@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Razi Nursing and Midwifery School
Full name of responsible person
Mansour Arab
Position
MSN/ Lecturer of Nursing
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)