Protocol summary

Summary
This study set out to examine the effects of Swedish massage on knee Osteoarthritis. This study is a randomized controlled trial of massage therapy for knee OA. A total of 46 adults (females aged at least 35 years) with knee OA were participated in this study. They were randomized in one of the two experimental treatment groups include standard treatment (ultrasound, infrared, Analgesic stimulation, and strengthening exercise for quadriceps) with Swedish massage and control group who received standard treatment. The pain and quality of life were evaluated by VAS and WOMAC scale before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201008114549N1
Registration date: 2010-10-31, 1389/08/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-10-31, 1389/08/09
Registrant information
Name
Elham Fatemy
Name of organization / entity
Semnan University Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 1335 4180
Email address
fatemy@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Semnan University of Medical Sciences
Expected recruitment start date
2008-04-01, 1387/01/13
Expected recruitment end date
2008-09-20, 1387/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Swedish massage on knee osteoarthritis
Public title
The effect of Swedish massage on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: woman with knee osteoarthritis, aged at least 35 years of age and had at least 5 from VAS pain assessment scale Exclusion criteria: presence of other musculoskeletal and medical condition that affect the knee, use of oral corticosteroids within the past 4 weeks, intra-articular knee depocorticosteroids within the previous 3 months, or intra-articular hyaluronate within the previous 6 months; arthroscopy of the knee within the previous year; significant injury to the knee within the previous 6 months; or a rash or open wound over the knee
Age
From 35 years old to 70 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size: 46
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
Semnan University of Medical Sciences
Street address
Kilometer 5 of Damghan road
City
Semnan
Postal code
3513138111
Approval date
2009-12-14, 1388/09/23
Ethics committee reference number
12809/2/آ

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M15, M19
ICD-10 code description
Arthrosis

Primary outcomes

1

Description
Pain
Timepoint
before and after intervention
Method of measurement
VAS scale

2

Description
Quality of life
Timepoint
before and after intervention
Method of measurement
womac scale

Secondary outcomes

empty

Intervention groups

1

Description
Control group: ultrasound: 0/5-1/5w/cm2, 5 minutes in medial and lateral joint line that gradually was increased. Trans-cutaneous electrical nerve stimulation: pulse duration 200-600msec, frequency 5-10 HZ, 20 minutes Infrared: 20 minutes strengthening exercises for quadriceps
Category
Rehabilitation

2

Description
Intervention group: ultrasound: 0/5-1/5w/cm2, 5 minutes in medial and lateral joint line that gradually was increased. Trans-cutaneous electrical nerve stimulation: pulse duration 200-600msec, frequency 5-10 HZ, 20 minutes Infrared: 20 minutes strengthening exercises for quadriceps as well as Swedish massage: tapping, petrissage, traction, Eflurage , 20 minutes
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
physiotherapy centers of Semnan University rehabilitation faculty
Full name of responsible person
Elham Fatemy
Street address
Semnan University of Medical Siences and Health Services
City
Semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan university of Medical Sciences and Health Services
Full name of responsible person
Dr Mohammad Faranoush
Street address
Semnan University of Medical Sciences and Health Services
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan university of Medical Sciences and Health Services
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
Semnan University of Medical Sciences and Health Services
Full name of responsible person
Elham Fatemy
Position
Instructor
Other areas of specialty/work
Street address
Semnan university of Medical Science andHealth Services
City
Semnan
Postal code
3513138111
Phone
+98 9802313354180
Fax
+98 23 1335 4180
Email
fatemy@sem-ums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan university of Medical Sciences and Health Services
Full name of responsible person
Elham Fatemy
Position
Ms/instructor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences and Health Services
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4180
Fax
+98 23 1335 4180
Email
fatemy@sem-ums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences and Health Services
Full name of responsible person
Elham Fatemy
Position
M.Sc/Insrtuctor
Other areas of specialty/work
Street address
Semnan university of Medical Science andHealth Services
City
Semnan
Postal code
Phone
+98 9802313354180
Fax
+98 23 1335 4180
Email
fatemy@sem-ums.ac.ir
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
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