The objective of the following research is to determine and compare the effect of reflexology of metatarsus and stretching on the excessiveness of pain in patients afflicted by rheumatoid arthritis. The mentioned research is a clinical trial and the environment of the trial is the rheumatology clinic of Yasouj Medical Science University. As the public of interest is limited the eligible samples would be selected applying random sampling procedure and they would be divided into 3 groups randomly. The number of the samples is 25 for each group and 75 in total. The criteria for entering the trial include patient's tendency for participating in the trial, being older than 18, definite diagnosis of rheumatoid arthritis by the specialist, owning pain degree of (4-7), pain measurement and total fatigue degree 50 and above 50 based on the questionnaire, lack of experience in participating at any regular exercise program in the last six months and being allowed to participate at exercise program according to the specialist. Criteria for existing from the trial include: lack of tendency to continue cooperation after the trial. On one group of the trial, reflexology and for the other, starching exercises would be performed for 12 30-minute sessions 3 times a week for a month. The trial would be performed based on the significance of reduction of pain and fatigue due to inflammation of the bones and joints and being informed about the fact that which one of these procedure is more effective in reducing symptoms in rheumatoid arthritis patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016112931166N1
Registration date:2017-01-30, 1395/11/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-30, 1395/11/11
Registrant information
Name
Majid Sadeghi
Name of organization / entity
Yasuj University of Medical Sciences Kohgiloyeh and Boyerahmad
Country
Iran (Islamic Republic of)
Phone
+98 74133337251
Email address
majidsadeghi100@gmail.com
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2016-12-15, 1395/09/25
Expected recruitment end date
2017-01-14, 1395/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of foot reflexology massage and stretching exercises on pain and fatigue of patients with rheumatoid arthritis
Public title
The effect of foot reflexology massage and stretching exercises in patients with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for entering trials include: patient's tendency for participating in the trial; being older than 18; definite diagnosis of rheumatoid arthritis by the specialist; at least a year must have passed from the diagnosis; owning pain degree of (4-7) and above average based on MFI-20 questionnaire; pain measurement and total fatigue degree 50 and above 50 based on numerical scale; lack of known psychological problems including depression; not being under medication with psychochemical drugs prior to the disease; not being afflicted by other chronic and hazardous diseases; not being afflicted by dermatological disease in feet and sensual disorders in feet; lack of experience of reflexology of metatarsus; lack of wound; fracture and dermatological and movement disorders in feet; passage of at least 4 hours from taking pain killers; not being addicted to drugs; lack of cardiovascular diseases in lower limbs; lack of experience in participating at any regular exercise program in the last six months and being allowed to participate at exercise programs with the specialist's confirmation.
Criteria for existing from the trial include: lack of tendency to continue the cooperation after the trial starts; alteration in any requirements of entering the trial; not being able to perform exercise program due to any reason; taking a new medication during the trial; being absent 4 cessions of the 12 cessions of the trial.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
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
Yasuj University of Medical Sciences
Street address
Yasuj, Motahari Boulevard, Yasuj University of Medical Sciences
City
Yasuj
Postal code
7591741417
Approval date
2016-10-29, 1395/08/08
Ethics committee reference number
IR.YUMS.REC.1395.151
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified
Primary outcomes
1
Description
Pain
Timepoint
Once the first day of the intervention and before intervention And again on the last day and within 10 minutes after intervention
Method of measurement
Numerical Pain Scale
Secondary outcomes
1
Description
Fatigue
Timepoint
Once the first day of the intervention and before intervention And again on the last day and within 10 minutes after intervention
Method of measurement
Multidimensional Fatigue Inventory
Intervention groups
1
Description
For trial group (1), reflexology of metatarsus would be performed in 3 levels including: preparation (5 minutes), warm up (10 minutes) and reflexology of metatarsus techniques (15 minutes) which last for a month, 3 30-minute sessions a week. The reflexive point starts from the end of the first knuckle of the finger and it ends in the sole. Preparation and warm up include warming up the feet by hands by determined movements, holding the foot from back and front by two hands and forming bending backwards movements, bending the metatarsus, rotation toward outside and movements in the sole. For stimulating reflexive points, massage would be performed using the fingers moving back and forth and by exerting a pressure about 0/5 centimeters.
Category
Other
2
Description
The patients of the trial would only receive the routine treatment for a month and no intervention would happen during this period. Before proceeding to any intervention, the excessiveness of pain and fatigue would be assessed in every 3 groups utilizing visual-criterion scale and MFI-20 fatigue multi-dimensional questionnaire.
Category
Other
3
Description
In trial group (2), stretching exercises would be used for intervention. Stretching exercises include 10 minutes of warm up, 15 minutes stretching and 5 minutes cooling down. Stretching exercises include 33 movements and have been chosen according to Bob Anderson stretching exercises in a way that no particular physical preparation is needed other than a simple warm up.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Doctor Mofateh Medical and Teaching Clinic affiliated to Yasuj University of Medical Sciences
Full name of responsible person
Shokrollah Behrozi
Street address
Yasuj, Montazeri Street, Adjacent to the Beheshti hospital
City
Yasouj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Dr Mohammad Malek Zadeh
Street address
Yasuj, Motahhari Boulevard, Yasuj University of Medical Sciences
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasuj 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
Yasuj University of Medical Sciences
Full name of responsible person
Shahla Najafi
Position
Faculty Member and Trainer
Other areas of specialty/work
Street address
Zeinab School of Nursing and Midwifery, Adjacent to the Imam Sajjad haspital
City
Yasuj
Postal code
7591741417
Phone
+98 74133234115
Fax
Email
Shahlaiss@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Shahla Najafi
Position
Faculty Member and Trainer
Other areas of specialty/work
Street address
Yasuj, Zeinab School of Nursing and Midwifery, Adjacent to the Imam Sajjad hospital
City
Yasuj
Postal code
7591994799
Phone
+98 74133234115
Fax
Email
shahlaiss@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zeinab School of Nursing and Midwifery
Full name of responsible person
Majid Sadeghi
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Yasuj, Zeinab School of Nursing and Midwifery
City
Yasuj
Postal code
7351819667
Phone
+98 71 4252 6047
Fax
Email
majidsadeghi100@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)