Determine the effect of foot reflexology on constipation in patients with MS
Design
Clinical trial with control group, Blind, randomized, with 54 patients
Settings and conduct
Janbazan Clinic of Arak
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18 to 50 years; informed consent, EDSS Expanded Disability Status Scale that measures the severity of MS patient disability less or equal to 4 . Constipation according to Rome IV criteria and doctor's approval.
Exclusion criteria: the presence of deformity or ulcer in the areas of massage on the palms of the feet; burn, use of hypnotic and antipyretic drugs, the presence of obstructive diseases of the gastrointestinal tract, inflammatory intestinal diseases, hypothyroidism, hyperparathyroidism, hypopituitarism expressed by the patient, irritable bowel syndrome according to physician confirmation, use of other complementary and alternative methods during the study.
Intervention groups
In the intervention group, patients takes 12 reflexology sessions twice a week for 6 weeks. Each session is 15 minutes massage for each leg, and includes 5 minutes for general massage of the foot and 10 minutes for massage on the gastrointestinal tract (stomach, liver, small intestine) and affecting the constipation.
in the control group, Patients do not receive any reflexology intervention. To unify the interventions, the caregiver of patient is required to touch on the feet for total of 12 sessions twice a week for 6 weeks without pressure.
Main outcome variables
Constipation and quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180103038211N5
Registration date:2018-10-20, 1397/07/28
Registration timing:registered_while_recruiting
Last update:2018-10-20, 1397/07/28
Update count:0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Fahime Davodabady
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 7610
Email address
F_davodabady@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of foot reflexology on constipation in patients with MS
Public title
The effect of reflexology on constipation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with MS who have Expanded Disability Status Scale (EDSS) equal or less than 4.
Patients with MS aged 18 to 50 years old
Informed consent
Exclusion criteria:
Use of other complementary and alternative methods during the study
History of Hypothyroidism, hyperparathyroidism, hypopituitarism declared by the patient
Sleeping and sedative medications, antidepressants and analgesics during the study
Having problems with the legs, including problems with blood flow (confirmed by the cardiologist)
The presence of burn, fungal infection, varicose veins, warts, corns and any kind of numbness in the leg
The presence of deformity or ulcer in the area of massage on the plantar area
Irritable bowel syndrome confirmed by a doctor
Gastrointestinal obstructive diseases, inflammatory digestive diseases
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Study population consists of patients who were registered in the MS center. Subjects were invited in the study with invitation letter. The Subjects with entry criteria were selected by simple sampling methods. Each person was given a number from 1 to n and then were assigned with using random numbers randomly to either an experimental or a control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Individuals with entry criteria are divided into intervention and control groups according to the random numbers table. One of the groups is A and the other is called B. Before and after the intervention, the information is collected by the evaluator of the outcome that is unaware of the Classification of the groups. Data analysis is also done by someone who is unaware of the allocation of groups. The control group also receive similar (but not effective) intervention so are unaware of the allocation to the intervention or 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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Approval date
2018-05-06, 1397/02/16
Ethics committee reference number
IR.ARAKMU.REC.1397.038
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35-G37
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Constipation
Timepoint
At the beginning of the study and at the end of the sixth week after the intervention began
Method of measurement
Constipation Assessment Scale (CAS)
2
Description
Quality of Life
Timepoint
At the beginning of the study and at the end of the sixth week after the intervention began
Method of measurement
Quality of life SF36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The study group receives 12 reflexology sessions for 30 minutes, twice a week for 6 weeks. Reflexology massage time is for 15 minutes, for each leg and includes general massage of the feet, and then massage the points related to the digestive tract (stomach, liver, small intestine and large) and affecting constipation. The reflexology is taught to the patient's caregiver and the accuracy of reflexology is ensured. Then reflexology is performed by the patient's caregiver at home for this period. We communicate with patients and follows through telephone and SMS.
Category
Treatment - Other
2
Description
Control group: Patients do not receive any reflexology intervention from the researcher. To unify the interventions, patient's caregiver touches the patient's foot surface for 30 minutes, twice a week for 6 weeks and also this patientes takes routine constipation treatment by the doctor.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Janbazan clinic
Full name of responsible person
Fahimeh Davodabady
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
arjomandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
Fahimedavodabady@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fahimeh Davodabady
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Province
Markazi
Postal code
6941-7-38481
Phone
+98 86 3417 3503
Email
fahimedavodabady@gmail.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