The effects of whole body vibration with exercise therapy vs exercise therapy alone on flexibility, vertical jump, agility and pain in athletes with patellofemoral pain syndrome
The aim of this study is to determine the effects of whole body vibration and exercise therapy with exercise therapy alone on the parameters of flexibility, vertical jump, agility and pain in athletes with patellofemoral pain syndrome.
Design
In this study, 24 patients with patellofemoral pain syndrome who have the inclusion criteria are select and randomly divided into two groups of intervention and control.
Settings and conduct
In this study, the effect of whole body vibration and exercise therapy are investigated before and one month later the intervention on the vertical jump, flexibility, agility and pain and the location of the study is the Clinic of Yazd Medical Sports Medicine; this is also blinded that the examiner will not be aware of which intervention will be administered to which subject. The patients aware of the existence of two different groups, but do not know about their groups (intervention or control).
Participants/Inclusion and exclusion criteria
Inclusion criteria are the people with antro or retropatellar pain, unilateral involvement, sports with leap and jump and exclusion criteria are history of dislocation or sublaxation of the patella, history of the hip, knee or ankle surgery.
Intervention groups
The control group will undergo exercise therapy 3 times per week for four weeks; whereas intervention group undergo exercise therapy in addition to whole body vibration training 3 times per week for four weeks.
Main outcome variables
Measured variables include: flexibility, vertical jump, agility and pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090831002391N39
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-03, 1396/11/14
Expected recruitment end date
2018-04-30, 1397/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of whole body vibration with exercise therapy vs exercise therapy alone on flexibility, vertical jump, agility and pain in athletes with patellofemoral pain syndrome
Public title
Effects of whole body vibration on flexibility, vertical jump, agility and pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-40 years male athletes
Antro or retropatellar pain
Physical activity at least 3 times a week for 2 hours
Unilateral involvement
Sports with leap and jump (soccer, volleyball, basketball, futsal and handball)
Report the pain at least in two of the activities of running, jumping, prolonged sitting, step up and down and squat
At least one of the tests being positive: step down eccentric test, patellar apprehension test, vastus medialis coordination test
Exclusion criteria:
History of dislocation or sublaxation of the patella
History of hip, knee or ankle surgery
Other lesion on the knee associated with this lesion
Kidney stone
Diabetes
Cardiovascular diseases
Epilepsy
Recent fracture
Gallstone
Acute disk herniation
Recent surgery
Acute arthritis
Pacemaker
Age
From 18 years old to 40 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups of test and control was done by Block Balanced Randomization (BBR) method. The Randomization Sequence is generated with using the free web site at http://www.randomization.com.
Blinding (investigator's opinion)
Double blinded
Blinding description
The examiner will not be aware of which intervention will be administered to which subject. The patients aware of the existence of two different groups, but do not know about their groups (treatment or control).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research in Shiraz University of Medical Science
Street address
Central building of Shiraz University of Medical Science, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2017-12-10, 1396/09/19
Ethics committee reference number
IR.SUMS.REC.1396.138
Health conditions studied
1
Description of health condition studied
Patellofemoral Pain Syndrome
ICD-10 code
M22.2X9
ICD-10 code description
Patellofemoral disorders, unspecified knee
Primary outcomes
1
Description
The effect of the whole body vibration training on flexibility
Timepoint
Before and 1 month after intervention
Method of measurement
Flexibility with sit and reach test
2
Description
The effect of the whole body vibration training on agility
Timepoint
Before and 1 month after intervention
Method of measurement
Agility with modified t-test
3
Description
The effect of the whole body vibration training on vertical jump
Timepoint
Before and 1 month after intervention
Method of measurement
Vertical jump by vertical jump test
4
Description
The effect of the whole body vibration training on pain
Timepoint
Before and 1 month after intervention
Method of measurement
Evaluation of pain by the visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, exercise therapy with whole body vibration training with frequency of 50 Hz and amplitude of 4 mm and for 2 sets 60 seconds with 30 second rest between sets are performed for 4 weeks and three times a week.
Category
Treatment - Other
2
Description
Control group: In the control group, exercise therapy is performed for 4 weeks and three times per week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Sports Medicine Board
Full name of responsible person
Ebrahim Rasti Esmat Abad
Street address
Hana Alley., Taleghani Blv., Yazd
City
Yazd
Province
Yazd
Postal code
8913844689
Phone
+98 35 3627 5008
Email
e.rasti67@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Seyed Basir Hashemi
Street address
Central building of Shiraz University of Medical Science, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashemib@sums.ac.ir
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, Shiraz 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
School of Rehabilitation Sciences
Full name of responsible person
Ebrahim Rasti Esmat Abad
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 2495
Email
e.rasti67@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
Zahra Rojhani Shirazi
Position
consultant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 1552
Email
rojhaniz@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
School of Rehabilitation Sciences
Full name of responsible person
ابراهیم راستی عصمت آباد
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Abiverdi1, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194733669
Phone
+98 71 3627 2495
Email
e.rasti67@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available