Protocol summary

Summary
Objective: comparison of patellar taping versus patellar bracing with exercise therapy on pain and level of function in females with patellofemoral pain syndrome Design of the study: randomized clinical trial Inclusion criteria: Subjects 18-43 y age; Pain level 3 or more on a 10cm visual analog scale; Onset of pain at least 3weeks but no greater than 2 months; Atraumatic peripatellar or retropatellar knee pain during at least 2 activities of prolonged sitting, increase in physical activity, climbing stairs, squatting, kneeling, running and jumping; Pain on palpation of the medial and lateral facet of the patella; Unilateral patellofemoral pain syndrome Exclusion criteria: History of knee joint surgery; History of subluxation or dislocation of the patella, meniscal damage, ligamentous instability, patellar tendon pathology and chondral damage; Clinical evidence of knee osteoarthritis; Spinal referred pain; Corticosteroid injection in the knee joint within the past 3 months; Pregnancy or the possibility of pregnancy; History of knee joint trauma; Neurological and orthopedic impairment that affected balance Sample size: 30 females with unilateral patellefemoral pain syndrome Interventions: the subjects is randomaly assigned to patellar taping with exercise therapy group and patellar bracing with exercise therapy group Duration of interventions: subjects complete 9 treatment sessions provide 3 times per week for 3 weeks Main outcome measures: pain, subjective and objective function is measured before and after interventions, pain intensity is quantified using a 10-cm visual analog scale, subjective function is assessed using kujala patellofemoral scale and objective function is also examined using performance functional tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015081123593N1
Registration date: 2015-09-27, 1394/07/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-09-27, 1394/07/05
Registrant information
Name
Maryam Farokhnia
Name of organization / entity
Musculoskeletal Rehabilitation Research Center
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3102
Email address
farokhnia.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahvaz Jundishapor University Of Medical Sciences
Expected recruitment start date
2015-09-01, 1394/06/10
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of patellar taping versus patellar bracing with exercise therapy on pain and function in females with patellofemoral pain syndrome
Public title
The effect of patellar taping and patellar bracing on pain and fuction in females with knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Subjects 18-43 y age; Pain level 3 or more on a 10cm visual analog scale; Onset of pain at least 3weeks but no greater than 2 months; Atraumatic peripatellar or retropatellar knee pain during at least 2 activities of prolonged sitting, increase in physical activity, climbing stairs, squatting, kneeling, running and jumping; Pain on palpation of the medial and lateral facet of the patella; Unilateral patellofemoral pain syndrome Exclusion criteria: History of knee joint surgery; History of subluxation or dislocation of the patella, meniscal damage, ligamentous instability, patellar tendon pathology and chondral damage; Clinical evidence of knee osteoarthritis; Spinal referred pain; Corticosteroid injection in the knee joint within the past 3 months; Pregnancy or the possibility of pregnancy; History of knee joint trauma; Neurological and orthopedic impairment that affected balance
Age
From 18 years old to 43 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics Committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
6135733133
Approval date
2015-06-06, 1394/03/16
Ethics committee reference number
IR.AJUMS.REC.1394.139

Health conditions studied

1

Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M22.2
ICD-10 code description
Patellofemoral disorders

Primary outcomes

1

Description
Pain
Timepoint
Before and after intervention
Method of measurement
Visual analog scale

2

Description
Subjective function
Timepoint
Before and after intervention
Method of measurement
kujala questionnaire

3

Description
Objective function
Timepoint
Before and after intervention
Method of measurement
Performance functional test

Secondary outcomes

empty

Intervention groups

1

Description
Internention1: McConnell patellar taping technique with exercise therapy program include stretching of hamstring, plantar flexor, quadriceps and iliotibial band muscles and strengthening of quadriceps, hip abductors and hip external rotators muscles
Category
Treatment - Other

2

Description
Intervention2: patellar bracing with exercise therapy program include stretching of hamstring, plantar flexor, quadriceps and iliotibial band muscles and strengthening of quadriceps, hip abductors and hip external rotators muscles
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Maryam Farokhnia
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Vice chancellor for research, Ahvaz Jundishapur Univercity of medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
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, Ahvaz Jundishapur 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
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Maryam Farokhnia
Position
B.Sc
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
6135733133
Phone
+98 61 3374 3102
Fax
Email
m.farokhnia7@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Shahla Zahednezhad
Position
Assistant Professor
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
6135733133
Phone
+98 61 3374 3102
Fax
Email
dr.shzahed@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Maryam Farokhnia
Position
B.Sc
Other areas of specialty/work
Street address
Musculoskeletal Rehabilitation Research Center, School of Rehabilitation Sciences, Ahvaz Jundishapur University of Medical Sciences, Golestan, Ahvaz, Iran
City
Ahvaz
Postal code
6135733133
Phone
+98 61 3374 3102
Fax
Email
m.farokhnia7@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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