Protocol summary
-
Study aim
-
The aim of this study is to evaluate the effectiveness of Kermanshahian Persian massage in relation to knee osteoarthritis.
-
Design
-
Blocked Randomization Clinical trial study
Sample size 42 for each of the treatment and control groups
-
Settings and conduct
-
Patients in the orthopedic clinic of Imam Hossein Hospital,diagnosed mild to moderate arthritis
The treatment group undergoes massage therapy by the researcher once a week and daily by the individual. In the control group, liquid paraffin is supplied to patients for daily use.
The duration of the study is 6 weeks and the WOMC and VAS questionnaires are completed at the beginning and after 3 and 6 weeks and 2 weeks after the completion of the treatment.
-
Participants/Inclusion and exclusion criteria
-
lnclusion:40 to 80 year old patients with mild to moderate osteoarthritis
Exclusion: Secondary osteoarthritis to rheumatoid diseases, History of Surgery on the knee, BMI higher than 35,Intra-articular or oral corticosteroid ingestion in the 3 months before and 2 weeks before,Pregnancy and breastfeeding
-
Intervention groups
-
The treatment group undergoes Kermanshahi's massage style
The control group,uses liquid paraffin for daily rubbing on the knee
-
Main outcome variables
-
VAS; WOMAC Pain; WOMAC Stiffness; WOMAC Physical Function; WOMAC Total; Number of Acetaminophen 500 per day
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20190121042438N1
Registration date:
2019-09-21, 1398/06/30
Registration timing:
registered_while_recruiting
Last update:
2019-09-24, 1398/07/02
Update count:
1
-
Registration date
-
2019-09-21, 1398/06/30
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2019-01-10, 1397/10/20
-
Expected recruitment end date
-
2020-01-10, 1398/10/20
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Study of the effect of Iranian traditional massage (Kermanshahi style) on clinical signs of knee osteoarthritis
-
Public title
-
Study of the effect of traditional massage on the symptoms of knee osteoarthritis
-
Purpose
-
Supportive
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
All 40 to 80 year old patients with mild to moderate osteoarthritis (according to ACR criteria) referring to Imam Hossein Orthopedic Clinic
Exclusion criteria:
Secondary osteoarthritis due to rheumatologic diseases
History of Surgery on the affected knee
BMI higher than 35
Intra-articular or oral corticosteroid ingestion in the 3 months before and 2 weeks before
Pregnancy and breastfeeding
-
Age
-
From 40 years old to 80 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
84
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Blocked Randomization with the help of computer software
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-01-08, 1397/10/18
-
Ethics committee reference number
-
IR.SBMU.RETECH.REC.1397.829
Health conditions studied
1
-
Description of health condition studied
-
knee Osteoarthritis
-
ICD-10 code
-
M17.0
-
ICD-10 code description
-
Bilateral primary osteoarthritis of knee
2
-
Description of health condition studied
-
Knee Osteoarthritis
-
ICD-10 code
-
M17.1
-
ICD-10 code description
-
Unilateral primary osteoarthritis of knee
Primary outcomes
1
-
Description
-
Score of knee pain intensity
-
Timepoint
-
Before the intervention,weeks 3 and 6 , and 2 weeks after the intervention
-
Method of measurement
-
Visual Analogue Scale and Western Ontario and McMaster universities osteoarthritis questionnaire
2
-
Description
-
Score of knee Stiffness intensity
-
Timepoint
-
Before the intervention,weeks 3 and 6 , and 2 weeks after the intervention
-
Method of measurement
-
Western Ontario and McMaster universities osteoarthritis questionnaire
Secondary outcomes
1
-
Description
-
score of daily physical activity
-
Timepoint
-
Before the intervention,weeks 3 and 6 , and 2 weeks after the intervention
-
Method of measurement
-
Western Ontario and McMaster universities osteoarthritis questionnaire
2
-
Description
-
Number of Acetaminophen tab 500mg used
-
Timepoint
-
At the beginning of the intervention, weeks 3 and 6
-
Method of measurement
-
Question from patient
Intervention groups
1
-
Description
-
Intervention group: Six weeks of weekly massage with chamomile oil by the researcher and daily massage by the patient
-
Category
-
Rehabilitation
2
-
Description
-
Control group: Six weeks of daily oil rubbing with liquid paraffin
-
Category
-
Rehabilitation
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shahid Beheshti 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
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
-
Patients have been given consent for information confidentiality.
-
Study Protocol
-
No - There is not a plan to make this available
-
Statistical Analysis Plan
-
No - There is not a plan to make this available
-
Informed Consent Form
-
No - There is not a plan to make this available
-
Clinical Study Report
-
No - There is not a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available