Protocol summary

Summary
In this study we want to exam the effect of whole body vibration training on pain, balance and performance.The aim of this study was to compare the effect of WBV Training and exercise therapy on pain, performance and balance in athletics person with patellofemoral pain syndrom. To this end, 28 athletes between the ages of 20-40 years with a diagnosis of patellofemoral pain syndrome attended to orthopedic and physiotherapy clinics affiliated to Shiraz University of Medical Sciences were selected and Randomly divided into the intervention and the control groups.Blocked randomization method was used for randomization. Treatment in the intervention group included 4 weeks WBV Training(12 sessions), each session included 5 sets of one minute duration with one minute rest between each set. The position of person was squat with 30 degree knee flextion. Frequency and amplifier is 30HZ and 3 mm. In control group, treatment included 4 weeks exercise therapy (12 sessions). The pain, performance and balance were measured before starting the treatment sessions, immediately after the end of sessions and and two weeks after completion of treatment and compared between both groups. Visual analogue scale Used to measure the pain intensity, leg press test and Kujala Questionnaire were used to measure the performance and Balance error scoring system and SEBT (Star Excursion Balance Test) were used to measure the balance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020624149N6
Registration date: 2016-06-16, 1395/03/27
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-06-16, 1395/03/27
Registrant information
Name
Fahimeh Kamali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1551
Email address
kamalif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between two protocol, whole body vibration and exercise therapy, on pain, performance and balance among 20-40 years-old athletes with patellofemoral pain syndrome
Public title
Effect of whole body vibration training on pain, performance and balance in athletes with patellofemoral pain syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: antro or retropatellar pain that is induced during step up and down, jumping up and running, squat, prolonged sitting; onset of symptoms has not been associated with traumatic factors; pain induction during patellar palpation; onset of symptom less than one year; the age range between 20-40years; only one leg involvement; at least one of below tests being positive: patellar apprehension test, vastus Medialis coordination test, step down eccentric test. exclusion criteria: symptoms duration for less than one month; existence of other lesions in the lower limb; surgery and fractures of lower extremity; history of patellar dislocation; usage of NSAIDs; signification injuries which affect other lower extremities joints; people who must not use WBV including acute fracture, lower limb amputation, acute damage of soft tissue, osteoporosis with vertebral fracture, acute disc herniation, recent surgery, acute edema, hip and knee endoprothesis, urinary incontinence, headache, epilepsy.
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Blocked randomization method is used for randomization

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Sciences Ethics committee of Shiraz University of Medical Sciences
Street address
Central Building of Shiraz University of Medical Sciences, Zand Blvd, Shiraz
City
Shiraz
Postal code
Approval date
2015-12-13, 1394/09/22
Ethics committee reference number
IR.SUMS.REC.1394.168

Health conditions studied

1

Description of health condition studied
patellofamoral pain syndrom
ICD-10 code
M70.8
ICD-10 code description
Other soft tissue disorders related to use, overuse and pressure

Primary outcomes

1

Description
pain
Timepoint
Before the onset of the treatment, at the end of the treatment period, two weeks after the end of the treatment period
Method of measurement
VAS (visual analog scale)

2

Description
Balance
Timepoint
Before the onset of the treatment, at the end of the treatment period, two weeks after the end of the treatment period
Method of measurement
Balance error scoring system; SEBT(star excursion balance test)

3

Description
Performance
Timepoint
Before the onset of the treatment, at the end of the treatment period, two weeks after the end of the treatment period
Method of measurement
Leg press, Kujala Questionnaire

Secondary outcomes

1

Description
-
Timepoint
-
Method of measurement
-

Intervention groups

1

Description
control group:exercise therapy .. included: patellar mobilization,rasistance training, flexibility, stretching and balance exercise
Category
Treatment - Other

2

Description
Intervention group: Whole body vibration Training Treatment was done 4 sessions per week for 4 weeks .Each session includes 5 sets of one minute duration with one minute rest between each two sets.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Orthopedic and Phisiotherapy Clinics affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Najmeh Shadlou
Street address
Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Basir Hashemi
Street address
Central Building of Shiraz University of Medical Science, Zand Blvd, Shiraz
City
Shiraz
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
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
School of Rehabilitation Science
Full name of responsible person
Najmeh Shadloo
Position
MS Student of Physiotherapy
Other areas of specialty/work
Street address
Abiverdy 1. Chamran Blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
shadlou.spt@gmsil.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Rehabilitation Science
Full name of responsible person
Dr fahimeh Kamali
Position
Associate Professor
Other areas of specialty/work
Street address
Abiverdy 1, Chamran Blvd
City
Shiraz
Postal code
Phone
+98 71 3627 1551
Fax
Email
fahimehkamali@hotmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Rehabilitation Science
Full name of responsible person
Najmeh Shadloo
Position
MS Student of Physiotherapy
Other areas of specialty/work
Street address
Aiverdy 1, Chamran Blvd
City
Shiraz
Postal code
Phone
Fax
Email
shadlou.spt@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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