The aim of this study was to compare the effect of orthosis on pain and daily activities of patients with patellofemoral pain syndrome. In this clinical trial, thirty men aged 18-40 years old with patellofemoral pain syndrome referred to Arak Valiasr hospital nonrandomly assigned into one of two groups to use Genodirex stable or Neoprene Palumbo orthosis. Using VAS score and KOOS questionnaire, ADL activities and joint stiffness were assessed before and 3 weeks after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810293101N1
Registration date:2010-03-06, 1388/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-03-06, 1388/12/15
Registrant information
Name
Mohamad Sadegh Ghasemi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 9086
Email address
m.s.ghasemi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Iran University of Medical Science
Expected recruitment start date
2008-01-15, 1386/10/25
Expected recruitment end date
2008-07-20, 1387/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Neoprene palumbo & Geno direxa stable orthoses on pain & daily activities in patients with Patello Femoral Pain Syndrome
Public title
Comparing the effects of two orthoses on pain & daily activities in patients with Patello Femoral Pain Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: VAS score 4, BMI of 25 - 26.5, Presence of Patello Femoral Pain Syndrome within 4 months prior to the study, Age 18-40 years old
Exclusion Criteria: Previous surgery, deformity, or limitation of motion in the lower limb
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical University, Faculty of Rehabilitation, Ethics Committee
Street address
Mohseni SQ, Shahnazari Street
City
Tehran
Postal code
4391-15875
Approval date
2008-01-30, 1386/11/10
Ethics committee reference number
124 (2008-01-30)
Health conditions studied
1
Description of health condition studied
Patello Femoral Pain Syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders
Primary outcomes
1
Description
Patello Femoral Pain and daily activities
Timepoint
Pre and 3 weeks Post
Method of measurement
VAS scale and KOOS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Neoprene palumbo orthosis
Category
Other
2
Description
Geno direxa stable orthosis
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran University of Medical Sciences, Faculty of Rehabili
Full name of responsible person
Mr. Majid Sharafi
Street address
Student Research Committe, Iran University of Medical University Faculty of Rehabilitation
City
Tehran
2
Recruitment center
Name of recruitment center
Vali Aser (AJ) Hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical University
Full name of responsible person
Dr M.Moradi Lakeh
Street address
Hemat Express Way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Iran University of Medical University
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
Faculty of Rehabilitation, Iran University of Medical University
Full name of responsible person
Dr Mohamad Sadegh Ghasemi
Position
Professor assistant, PhD
Other areas of specialty/work
Street address
Mohseni SQ, Shahnazari Street
City
Tehran
Postal code
15875-4391
Phone
+98 21 2222 9086
Fax
Email
m.s.ghasemi@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Rehabilitation, Iran University of Medical University,
Full name of responsible person
Dr. Mohammadsadegh Ghasemi
Position
Assistant Professor PhD
Other areas of specialty/work
Street address
Mohseni SQ, Shahnazari Street
City
Tehran
Postal code
15875-4391
Phone
+98 21 2222 9086
Fax
Email
m.s.ghasemi@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)