Effect of massage therapy on mental-health co-morbidity and complications related to quality of life in people with MS-a randomized controlled clinical trial
Investigating the effect of massage therapy on psycho-physical complications and co-morbidity related to quality of life in people with MS.
Design
A unblinded community-based, randomized, controlled clinical trial with a parallel groups. Participants in this Phase III of clinical trial study included 70 patients with MS.
Settings and conduct
The present study will be carried out at the Neuromuscular Rehabilitation Center of Semnan University of Medical Sciences. Because of the nature of the study, the participants are not blind to the division into groups, but statisticians and evaluators split the participants into groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age over 16 years; At least the reading and writing skills; Confirmation of a recurrent or secondary progressive MS disease by a specialist; EDSS scores ranging from 0/3 to 0/7; Ability to stand without assistance for at least 60 seconds (if necessary with auxiliary equipment); The ability to walk 10 meters safely with or without auxiliary equipment.
Exclusion criteria: Deep vein thrombosis (DVT) Uncontrolled; Uncontrolled high blood pressure (systolic blood pressure 180 mm Hg on diastolic 100 mm Hg); Confirmation of unstable angina and / or heart attack (myocardial infarction) during the past month; Diabetes.
Intervention groups
Intervention group: The participants in this group receive the Swedish standard massage by trained physiotherapists. The program provides massage therapists for approximately 70 minutes each week for two session, for a period of 6 weeks, in a quiet room, on a massage table, they will receive a massage therapist.
Control group: They receive their routine treatments
Main outcome variables
Health-related quality of life; Pain; Fatigue; Muscular spasticity; Stress, anxiety and depression; Sleep quality
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170114031942N7
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
Registrant information
Name
Aynollah Naderi
Name of organization / entity
Shahrood University of Technology
Country
Iran (Islamic Republic of)
Phone
+98 917 721 7462
Email address
ay.naderi@shahroodut.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-06-07, 1397/03/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of massage therapy on mental-health co-morbidity and complications related to quality of life in people with MS-a randomized controlled clinical trial
Public title
Massage therapy and MS
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 16 years
At least the reading and writing skills
Confirmation of a recurrent or secondary progressive MS disease by an specialist
EDSS scores ranging from 0/3 to 0/7
Ability to stand without assistance for at least 60 seconds (if necessary with auxiliary equipment)
The ability to walk 10 meters safely with or without auxiliary equipment
Exclusion criteria:
Deep vein thrombosis (DVT) Uncontrolled
Uncontrolled high blood pressure (systolic blood pressure 180 mm Hg on diastolic 100 mm Hg)
Confirmation of unstable angina and / or heart attack (myocardial infarction) during the past month
Diabetes
Arthritis, injuries or non-fixed fractures of the lower limbs
Other injuries or neurological diseases
Pregnancy or intending to get pregnant
Get a massage in the past six months or get physical therapy program before the start of the study
Inability to easily get out of the wheelchair and go to the massage table
Lack of regular participation in massage sessions
Age
From 16 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are firstly enrolled by one of the research colleagues. Then, an independent assessor, blinded person who has no further involvement in the study creates a random allocation sequence using a computer Software prior to the initiation of the study that use to randomize participants with 1:1 allocation ratio. A block randomization design (block size of 2,4,6) are applied to ensure an equal number of participants in each group. Group allocation are concealed in sequentially numbered, opaque, sealed envelopes, and corresponding envelopes are opened after enrolled participants complete all baseline assessments.
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
Semnan University of Medical Sciences And Health Services
Street address
No. 2, Damghan road, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
99951- 35198
Approval date
2018-02-06, 1396/11/17
Ethics committee reference number
IR.SEMUMS.REC.1396.215
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
Health-related quality of life
Timepoint
Health-related quality of life is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
Health-related quality of life measured by MSQoL Multiple Sclerosis Quality of Life-54
2
Description
Pain
Timepoint
Pain is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
The pain is measured by visual analog scale.
3
Description
Fatigue
Timepoint
Fatigue is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
Fatigue is measured by the fatigue intensity index
4
Description
Muscular spasticity
Timepoint
Muscular spasticity is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
Muscular spasticity measured by the Modified Ashors Scale.
5
Description
Stress, anxiety and depression
Timepoint
Stress, anxiety and depression is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
Stress, anxiety and depression are measured by the short scale of depression, anxiety and stress.
6
Description
Sleep quality
Timepoint
Sleep quality is measured at beginning of the study and 6 weeks after starting the massage therapy
Method of measurement
Sleep quality is assessed by the Pittsburgh Sleep Quality Index.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The participants in this group receive the Swedish standard massage by trained physiotherapists. The program provides massage therapists for approximately 70 minutes each week for two session, for a period of 6 weeks, in a quiet room, on a massage table, they will receive a massage therapist.
Category
Rehabilitation
2
Description
Control group: They receive their routine treatments
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan University of Medical Sciences and Health Services
Full name of responsible person
Atefe Aminian far
Street address
No. 2, Damghan road, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3344 1022
Email
ay.naderi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Technology
Full name of responsible person
Aynollah Naderi
Street address
Tehran avenue, Shahroud, Semnan province
City
Shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
ay.naderi@yahoo.com
Grant name
Shahroud University of Technology
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud University of Technology
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Atefe Aminian Far
Street address
No. 2, Damghan road, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
99951- 35198
Phone
+98 23 3344 1022
Email
ay.naderi@yahoo.com
Grant name
Semnan University of Medical Sciences and Health Services
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan University of Medical Sciences
Proportion provided by this source
50
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
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Science
Street address
Tehran Avenue, Shahroud, Semnan Province
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran Avenue, Shahroud, Semnan Province
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahrood University of Technology
Full name of responsible person
Aynollah Naderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education and Sports Science
Street address
Tehran Avenue, Shahroud, Semnan Province
City
shahroud
Province
Semnan
Postal code
3619995161
Phone
+98 23 3239 2204
Email
Ay.naderi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD