Protocol summary

Summary
Objectives: Comparision of two muscle taping techniques on the pain, electromyographic activity and dynamic balance in athletes with patellofemoral pain syndrome. Design:This is a randomized, blind, clinical trial. Thirty two athletes will be randomly assigned to two groups: Vastus Lateralis (VL) inhibitory taping and Vastus Medialis Obliqus (VMO) facillatory taping technique. Participants: 32 athletes aged 18-40 years old will tak part in the study. Inclusion critria: unilateral anterior or retropatellar knee pain; existance of symptoms for at least 2 month and an average pain level of 3 on visual analog scale. Exclusion critria: history of hip; knee or ankle surgery; a history of patellar dislocation or subluxation; or clinical evidence of meniscal lesion and ligamentous instability. Interventions: Kinesiologic tape will be attached to VL inhibitory group from from tibial tuberosity following VL path, up to 1/3 of the proximal tigh. for VMO facillatory group Kinesiologic tape will be attached from 1/3 of the proximal tigh following VMO path down to tibial tuberosity. Iindividuals in both groups will be assessed for pain, electromyographic activity of vasti in voluntary heel and toe raises and postural balance before and after interventions. Main Outcome Measures: participants will rate the perceived pain level using the 10-cm visual analog scale, electromyographic onset and activity of VMO and VL assesse during heel rise and down, Reach distance that normalize by dividing the distance by the participants’ leg length during star excursion balance test performance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014071515932N3
Registration date: 2014-08-16, 1393/05/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-08-16, 1393/05/25
Registrant information
Name
Alireza Motealleh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1626 5108
Email address
motealleh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-08-23, 1393/06/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two taping methods on pain, EMG activity and dynamic balance in athletes with patellofemoral pain syndrome
Public title
The effect of taping on performance in athletes with patellofemoral pain syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion critria: unilateral anterior or retropatellar knee pain while engaged in at least 2 of the following activities: prolonged sitting, climbing stairs, squatting, running, kneeling and jumping; existance of symptoms for at least 2 month; an average pain level of 3cm on a 10-cm visual analog scale; an insidious onset of symptoms unrelated to a traumatic incident and at least grade 11 in Functional Index Questionnaire. ٍExclusion critria: recent history of hip; knee or ankle surgery; a history of patellar dislocation or subluxation; or clinical evidence of meniscal lesion; ligamentous instability; patellar tendon pathology; chondral damage; osteoarthritis; or spinal referred pain; systemic diseases such as diabetes and rheumatism and bilateral PFP.
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
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
Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Postal code
71345-1987
Approval date
2014-06-28, 1393/04/07
Ethics committee reference number
ct-9373-7053

Health conditions studied

1

Description of health condition studied
Patellofemoral pain syndrome
ICD-10 code
M94.2
ICD-10 code description
Chondromalacia

Primary outcomes

1

Description
The onse and amplitude of electromyographic activity
Timepoint
Before the intervention and immediately after intervention
Method of measurement
Telemetry EMG (Mega electronics Ltd.Finland)

2

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

3

Description
Reach distance in dynamic balance
Timepoint
Before the intervention and immediately after intervention
Method of measurement
Tape

Secondary outcomes

empty

Intervention groups

1

Description
Kinesiologic tape will be attached with 15%-25% tension to VL inhibitory group from insertion to origin so it will be applied from tibial tuberosity following VL path, up to 1/3 of the proximal tigh.
Category
Rehabilitation

2

Description
For VMO facillatory group tape with 25%-50% tension will be attached from origin to insertion so it will be applied from 1/3 of the proximal tigh following VMO path down to tibial tuberosity
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghadir sports club
Full name of responsible person
Ms Zaravar
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmeddini
Street address
Vice-Chancellery of Research, Shiraz University of Medical Sciences, Zand Ave.
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz School of Rehabilitation, Shiraz University of Medical Sciences
Full name of responsible person
Vahideh Foroozantabar
Position
Student
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard.
City
Shiraz
Postal code
Phone
+98 71 1626 2240
Fax
Email
Foroozantabar.v@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz School of Rehabilitation, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Alireza Motealleh
Position
Assistant Ppofessor of Shiraz University of Medical Sciences
Other areas of specialty/work
Street address
Shiraz School of Rehabilitation, First Abiverdi Ave, Chamran Boulevard.
City
Shiraz
Postal code
Phone
+98 71 1626 1081
Fax
Email
Pmotealeh@yahoo.commotealleh@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz School of Rehabilitation
Full name of responsible person
Vahideh Foroozantabar
Position
Student
Other areas of specialty/work
Street address
First Abiverdi, Chamran Boulevard
City
Shiraz
Postal code
Phone
+98 71 1626 2240
Fax
Email
Foroozantabar.v@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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