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IRCT20170114031942N7 IRCT 2018-05-29 Shahroud University of Technology Massage therapy and MS 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 2018-05-22 anticipated 70 Complete https://irct.ir/trial/31271 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, 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. 3 Multiple sclerosis. Intervention 1: 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. Intervention 2: Control group: They receive their routine treatments. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information.
public Aynollah Naderi
Tehran Avenue, Shahroud, Semnan Province
shahroud Iran (Islamic Republic of) 3619995161 +98 23 3239 2204 Ay.naderi@yahoo.com Shahrood University of Technology scientific Aynollah Naderi
Tehran Avenue, Shahroud, Semnan Province
shahroud Iran (Islamic Republic of) 3619995161 +98 23 3239 2204 Ay.naderi@yahoo.com Shahrood University of Technology Iran (Islamic Republic of) 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 16 years no limit Both 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 G35 Multiple sclerosis Rehabilitation Other 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 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. 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. 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. 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. 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. 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. Semnan University of Medical Sciences Shahroud University of Technology Semnan University of Medical Sciences Approved 2018-02-06 Semnan University of Medical Sciences And Health Services No. 2, Damghan road, Basij Blvd, Semnan Semnan Semnan Iran (Islamic Republic of)