Protocol summary

Summary
The purpose of this study is to compare the effectiveness of open and closed kinetic chain exercise therapy in reducing knee pain and improving the normal function of the patients with patellofemoral pain syndrome. This study will be done as the single-center randomized clinical trial in patients with patellofemoral pain syndrome, referred to Rasool-e-Akram hospital. Inclusion criteria are anterior knee pain for at least two months, Positive Clark's test, induction of the pain in up or down stairs and other knee full flexion situations. Exclusion criteria are knee osteoarthritis and other associated problems of the knee. In this study 64 patients eligible for inclusion, will be divided in two groups by block randomization. The first group will receive open-kinetic chain exercises and the second the closed-kinetic chain exercises. The open chain exercises group will do quadriceps static contraction and straight leg raising exercises. The closed chain exercise group will do semi squat, wall slide and step ups. The patient's pain and function will be assessed pre intervention , one and two months post intervention by Visual Analogue Scale ruler, Kujala and Functional Index questionnaires.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014090719073N1
Registration date: 2016-03-18, 1394/12/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-03-18, 1394/12/28
Registrant information
Name
Ali Mazaherinezhad
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
mazaherinezhad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effectiveness of open and closed kinetic chain exercise in reducing knee pain and improving the normal function of the patients with patellofemoral pain syndrome
Public title
comparison of two methods of exercise therapy in patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: feeling of pain on the anterior or posterior part of the knee or around patella at least for 2 months ; Positive Clark's test; induction of pain in at least two of following situation: in up or down-stair, squatting, running, jumping, cycling, kneeling and sitting with flexed knee for prolong period. Exclusion criteria:Pain intensity less than score 3 according to VAS; history of Knee locking; patellar dislocation; knee osteoarthritis; abnormal finding in the knee X-ray; knee infection; Knee ligaments injuries; Knee physiotherapy for the 3 recent months; history of knee surgery;Knee traumatic injuries; genovalgum and Osgood- Schlatter or any other pathologic diseases.
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 64
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
Iran University of Medical Sciences
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
City
Tehran
Postal code
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
93-02-30-24740-104043

Health conditions studied

1

Description of health condition studied
Chondromalacia patella
ICD-10 code
M22.4
ICD-10 code description
Disorders of patella

Primary outcomes

1

Description
pain
Timepoint
before intervention, 1 months after intervention, 2 months after intervention
Method of measurement
Visual Analogue Scale ruller

2

Description
knee performance
Timepoint
before intervention, 1 months after intervention, 2 months after intervention
Method of measurement
Kujala questiannaire و Functional Index questionnaire

Secondary outcomes

1

Description
---
Timepoint
---
Method of measurement
---

Intervention groups

1

Description
The patients in open chain exercises group will do static quadriceps contraction and the Straight leg raising exercises for two months.In the first week, they will do the exercises two times a day with ten repetitions, the hold time of static contraction will be ten seconds.The exercise therapy program will be progressed to three times a day in the second week and three times a day with 15 repetitions in the third week. At the fourth week, the exercise therapy program will be progressed to three times a day and the hold time of static contraction will be 15 seconds. The progression of exercise therapy will continue in the same way until the end of the 8th week.
Category
Rehabilitation

2

Description
The patients in the closed chain exercises group will do semi-squat, wall slide and step ups for two months. The progression method of exercise therapy in closed chain exercises group will be as same as the open chain exercises group.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasool-e-Akram Hospital
Full name of responsible person
Ali Mazaherinezhad
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Seyed Ali Javad Moosavi
Street address
Iran University of Medical sciences, south side of Hemmat highway, Tehran, Iran.
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 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
Iran University of medical sciences
Full name of responsible person
Ali Mazaherinezhad
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
mazaherinezhad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran university of medical Sciences
Full name of responsible person
ََAli Mazaherinezhad
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
mazaherinezhad@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
َAli Mazaherinezhad
Position
Assistant Professor
Other areas of specialty/work
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6435 2446
Fax
Email
mazaherinezhad@gmail.com
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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