Protocol summary

Summary
Goal: This study with the goal of determination of the effectiveness of olive oil, Paraffin, Pyroxicom and dry massage on controlling of morning inflammatory pain of phalanges and knees among women with Rheumatoid Arthritis was accomplished. Inclussion criteria: to be Volunteer; At least one year passed from their disease diagnosis Exclusion criteria: Suffering from Osteoartheritis; Inability for hand and foot massage by herself Intervention: After selecting 60 women with rheumatoid arthritis based on convenience sampling method from Ami-Al Momenin hospital and taking consent forms, they randomly allocated in to 5 groups. Then the demographic, Disease Activity Score (DAS 28) and visual analogue scales related to their arthralgia were complete. For 12 weeks routine drugs (prednisolon tab. 5-7.5 mg/daily; Hydrochlorokine tab. 200mg/daily; Metotraxate tab. 7.5 mg/daily and Folic Acid tab. 5 mg/daily) + knee massage with olive oil to G1( 5 ml/ q8h), routine drugs + Paraffin oil to G2( 5 ml/ q8h), only routine drugs to G3, routine drugs + dry massage of knee to G4, and routine drugs + Pyroxicam jel to G5( 5 cm/ q8h) will be given.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201110134519N3
Registration date: 2013-02-02, 1391/11/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-02, 1391/11/14
Registrant information
Name
Davood Hekmatpou
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1417 3645
Email address
dr_hekmat@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2012-05-16, 1391/02/27
Expected recruitment end date
2012-08-17, 1391/05/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of olive oil, Paraffin, Pyroxicom and dry massage on controlling of morning inflammatory pain of phalanges and knees among women with rheumatoid arthritis (R.A): A Clinical Trial
Public title
The effectiveness of olive oil on controlling of morning inflammatory pain of phalanges and knees among women with rheumatoid arthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: to be Volunteer ; At least one year passed from their disease diagnosis and be under consideration of one rheumatologist ; without neuromuscular diseases ; to be able to massage their own hands and knees Exclusion Criteria: Suffering from Osteoartheritis; Inability for hand and foot massage by herself; suffering from incurable diseases
Age
From 39 years old to 66 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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
Basij Sq. Arak
City
Arak
Postal code
Approval date
2011-10-17, 1390/07/25
Ethics committee reference number
114-90-7

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M05.9
ICD-10 code description
Seropositive , unspecified

Primary outcomes

1

Description
pain
Timepoint
3 months
Method of measurement
VAS

Secondary outcomes

1

Description
Disease Activity Score
Timepoint
3 months
Method of measurement
DAS 28

Intervention groups

1

Description
G 2: routine drugs + Paraffin oil ( 5 ml/ q8h)
Category
Treatment - Other

2

Description
G1: routine drugs (prednisolon tab. 5-7.5 mg/daily; Hydrochlorokine tab. 200mg/daily; Metotraxate tab. 7.5 mg/daily and Folic Acid tab. 5 mg/daily) + knee massage with olive oil (5 ml/ q8h)
Category
Treatment - Other

3

Description
G5: routine drugs + Pyroxicam jel ( 5 cm/ q8h)
Category
Treatment - Other

4

Description
G3 (control group): only routine drugs
Category
Treatment - Drugs

5

Description
G4: routine drugs + dry massage of knee
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir Almomenin Hospital
Full name of responsible person
Dr. Davood Hekmatpou
Street address
Basij Sq.
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Street address
Basij Sq.
City
Arak
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
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
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D /Research Manager
Other areas of specialty/work
Street address
Basij Sq.
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
dr_hekmat@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Basij Sq.
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
dr_hekmat@arakmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Davood Hekmatpou
Position
Ph.D/ Research Manager
Other areas of specialty/work
Street address
Basij Sq
City
Arak
Postal code
Phone
+98 86 1417 3645
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...