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The effect of taping and education of quadriceps strengthening and hamstring stretching on patella-femoral pain syndrome : A Randomized clinical trial

Protocol summary

Study aim
Determining the Effectiveness of quadriceps strengthening and hamstring stretching exercises on PFPS
Design
According to the entry and exit criteria and after obtaining the consent of the individuals, the clients will be acquainted with the objectives of the research in one session and then will be randomly grouped.
Settings and conduct
Knee tipping: Once a week, for 8 weeks, by a doctor Quadri's strength training then and hamstring pull: For 8 weeks, bilateral, the first week of training is done under the supervision of a doctor in the sports medicine department, and the continuation of training at home is done without supervision.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No Allergy to Stripping, No Proof Diagnoses such as Intra-Articular Injury (such as Ligamen and Minsk Ruptures), Lack of Plica Syndrome, Larsen Johnson, Sgood Schlatter, Bursitis, Tendonitis, Norma, Infectious Arthritis, Osteoarthritis and Tumor Trauma, Lack of metabolic diseases associated with calcium and phosphor Exclusion criteria:Patient's unwillingness to continue treatment ,Allergy to tape, Patient's absence from follow-up for more than 3 sessions , BMI greater than 30
Intervention groups
1- quadriceps strengthening Exercise with taping 2- hamstring stretching with taping 3- quadriceps strengthening plus hamstring stretching exercise 4- quadriceps strengthening ، hamstring stretching exercise and taping
Main outcome variables
Age, Type of treatment, Education level, Income level, Age at diagnosis, Weight, Height, BMI, Occupation, medication history, VAS, KOOS, A- 6 min walk test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140708018409N2
Registration date: 2020-05-07, 1399/02/18
Registration timing: retrospective

Last update: 2020-05-07, 1399/02/18
Update count: 0
Registration date
2020-05-07, 1399/02/18
Registrant information
Name
Gholamreza Partovi
Name of organization / entity
Mazandaran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
ghpartovi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of taping and education of quadriceps strengthening and hamstring stretching on patella-femoral pain syndrome : A Randomized clinical trial
Public title
The effect of taping and education of quadriceps strengthening and hamstring stretching
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of allergy to tape Lack of evidence of intra-articular injury (eg,ligament and meniscuse rupture) Lack of PlIca Syndrome - Larsen Johansson disease, Osgood-Schlatter disease , Bursitis,Tendonitis, Neuroma, Infectious arthritis, Bone fracture's, Tumor, Accident (Trauma) Lack of metabolic diseases associated with Ca and P Grade 2 and grade 3 osteoarthritis based on kellgren lawrence radiography criteria Not used taping for at least 7 days prior to study No exercise training at least 1 month prior to study Don't use painkillers for at least 1 week before the study
Exclusion criteria:
Patient's unwillingness to continue treatment Allergic reaction to tape More than 3 sessions absence in treatment sessions BMI greater than 30
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining consent from individuals, they will be introduced to the objectives of the research in one session. Then, using 4 blocks, a number from 1 to 4 (identifying the number of the study group) is selected by the patient and the random grouping of patients will be determined.
Blinding (investigator's opinion)
Single blinded
Blinding description
Since the patient knows which group he is in but the evaluator dose not know so this study is one-way blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Moalem Street, Moalem Square., Vice chancellor for research, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2019-07-10, 1398/04/19
Ethics committee reference number
IR.MAZUMS.REC.1398.3552

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
Visual Analog Scale for pain - Knee Injury and Osteoarthritis Outcome Score Questionnaire (KOOS) - 6 min walk test
Timepoint
Before and After of 8 weeks intervention
Method of measurement
The VAS and KOOS criteria are based on the questionnaire and the 6-minute walk test is practically determined at a specific location within 6 minutes In meter.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1. quadriceps strengthening exercise and taping combination therapy group. Taping: once a week, for 8 weeks by a doctor in the knee by McConnell method, in the middle of the patella, the patient lies down and the knee is extended and relax the quadriceps .The pressure is applied to the posterosuperior. A layer of type is 50 mm wide, flexible, hypo-alergic And it's Ares Godlisha made in South Korea. Quadriceps Strength protocol: In this protocol, 4 exercises were selected so that it is more suitable for the activity of Vastus medialis (VMO) than the rectus femoris muscle and in performing the exercises, the emphasis was on the painlessness of these methods. 1) 1/2 long sit: towel under knee In this exercise, the person is sitting with one knee and the other at 60 degrees of flexion, and the hands are placed next to the body with the elbow is extended. The person puts a folded towel under his knee and has to press it for 10 seconds,10 times, 3 sets daily, which is a total of 300 seconds of pressure, then will be repeat on other knee. 2) ½ long sit: towel under heel: The whole procedure is similar to the previous exercise, only the towel should be placed under the heel and we apply pressure with the heel. 3) 1/2 long sit: heel lift: The patient should be in the Mentioned earlier position and raise his heels of the extended knee so that the extended knee and the flexed knee are facing each other on one level and in terms of time and number of times similar to the previous exercises. 4)1/4 lie or supine :low leg lift ,only calf touches board-floor: The patient is in the supine position and will be raises his lower limbs to some extension that only the muscles behind the leg are in contact with the ground or the board, and in terms of time and numbers are similar to the previous cases. These 4 exercises are performed for 8 weeks according to the instructions are followed.
Category
Treatment - Devices

2

Description
Intervention group: 2. Taping and hamstring stretching combination therapy group. Because in intervention number 1, the way of typing is described, only here the way of stretching exercise explained.    Hamstring stretching training protocol: Hamstring stretching exercises are performed with a large towel. The patient should be in the supine position and pass a towel at his sole of the front half of the foot and with each hand, he took the towel on the same side and while the knee is in extension, bring lower limbs up When pulling on both sides of the towel, while not bending the knee, feel the stretch without causing pain in his hamstring muscle. This exercise is performed in 10 sets of 10 seconds for 3 times a day for 8 weeks.
Category
Treatment - Devices

3

Description
Intervention group: 3. quadriceps strengthening and hamstring stretching exercise combination therapy group. These protocols were described in Interventions 1 and 2.
Category
Treatment - Devices

4

Description
Intervention group: 4. Tapping ، quadriceps strengthening and hamstring stretching exercise combination therapy group.These protocols were described in Interventions 1 and 2.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafavian Clinic
Full name of responsible person
Dr. Gholamreza Partovi
Street address
razi 3
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Email
ghpartovi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moallem
City
Sari
Province
Mazandaran
Postal code
4471848178
Phone
+98 11 3325 7230
Email
pajooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Ave., Emam Khomeyni Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Ave., Emam Khomeyni Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Amir Mazandarani Ave., Emam Khomeyni Hospital
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
results of statistical analysis and its analysis
When the data will become available and for how long
Start of access 12 months after printing results
To whom data/document is available
Health researchers
Under which criteria data/document could be used
view data
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
About 2 months
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