Evaluation of the effect of whole body electrical muscle stimulation and common strengthening exercises on pain and improvement of function in women with patellofemoral pain syndrome
Comparison of the effectiveness of two treatment protocol of strengthening exercises and strengthening exercises with whole body electrical stimulation on improving pain and function in women with patellofemoral pain syndrome.
Design
Two arm parallel group randomised trial، 60 women with patellofemoral pain syndrome
Settings and conduct
This study, which will be performed in physiotherapy center of Ayatollah Taleghani Hospital in Ahvaz, 60 women with patellofemoral pain syndrome participate. Includes two groups: 1- Therapeutic exercises (doing 7 weeks of knee and hip strengthening exercises) 2- group of whole body electrical stimulation and strengthening exercises (7 weeks of electrical stimulation with exercises)
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Female( 18-40 )
Pain in anterior of knee or posterior the patella in one or both knees that is exacerbated in at least 2 of the following activities: sitting too much, squatting, going up and down stairs, kneeling, jumping and running
Exclusion criteria;
History of previous surgery and injury on the knee joint.
Having a pacemaker, implant .
Pregnancy.
Epilepsy
Intervention groups
The exercise group(control), include strengthening exercise hip and knee muscles, which will be based on the standard rehabilitation protocol in patients with patellofemoral pain, and the second group performs these exercises with the whole body electrical stimulation.
Main outcome variables
pain، physical performance
General information
Reason for update
Acronym
PFPS
IRCT registration information
IRCT registration number:IRCT20220421054600N1
Registration date:2022-07-04, 1401/04/13
Registration timing:registered_while_recruiting
Last update:2022-07-04, 1401/04/13
Update count:0
Registration date
2022-07-04, 1401/04/13
Registrant information
Name
Maryam Kiani haft lang
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3554 0256
Email address
maryamkiani1371.hlg@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-22, 1401/04/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of whole body electrical muscle stimulation and common strengthening exercises on pain and improvement of function in women with patellofemoral pain syndrome
Public title
Whole body electrical muscle stimulation in patellofemoral pain syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Young women with a gradual onset of anterior knee pain without a history of trauma for at least 6 months.
Exclusion criteria:
Any intra-articular symptoms such as ligament and meniscal injury.
Existence of pain and tenderness in the patellar tendon, the internal hamstring tendon , ilio tibial band.
Osgood Schlatter or Sinding Larsen-Johansson syndrome.
Referral pain of hip and lumbar.
History of patellar dislocation.
History of previous surgery on the patellofemoral joint.
Existence of signs of degeneration in radiographic finding.
Taking corticosteroids and anti-inflammatory drugs.
Having a pacemaker, implant .
Pregnancy.
Epilepsy.
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
People with patellofemoral pain syndrome are randomly divided into two groups include: strengthening exercises and strengthening exercises with electrical stimulation of the whole body by tossing coins.
Blinding (investigator's opinion)
Single blinded
Blinding description
Three specialist are involved in the study process. The first specialist is in charge of the evaluation, the second specialist is in charge of therapeutic interventions, and the third specialist is in charge of analyzing the results. In this study, the specialist who evaluations patient is blind
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahvaz Rehabilitation School
Street address
Blv Golestan,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Approval date
2022-02-08, 1400/11/19
Ethics committee reference number
IR.AJUMS.REC.1401.021
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 score in the visual analogue scale
Timepoint
Measurement of pain at the beginning of the study, seven weeks and three months after starting interventions.
Method of measurement
Visual analogue scale
2
Description
Function(strength)
Timepoint
Measurement of function (strength ) at the beginning of the study, seven weeks and three months after starting interventions.
Method of measurement
Dynamometer
3
Description
Function (Step down test)
Timepoint
Measurement of function (step down test ) at the beginning of the study, seven weeks and three months after starting interventions.
Method of measurement
The number of repetitions
4
Description
Function(muscle endurance)
Timepoint
Measurement of function (muscle endurance) at the beginning of the study, seven weeks and three months after starting interventions.
Method of measurement
time
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Exercise therapy with whole body electrical stimulation .The treatment protocol in this group includes the knee and hip muscles strengthening : quadriceps isometric contraction, abductor and external-internal rotator muscles, single leg raising in all plane, weigth training , elastic band training in all plane, lower extermity balance training( static and movable surface with tilt board) (three times per week) and whole body electrical stimulation (1.5 sessions per week : 1 session per week and in the next week 2 session per week ). This protocol is performed for seven weeks .frequency of current is 50 hz, puls duration 350 micoro sescend and treatment time-15 min
Category
Rehabilitation
2
Description
Control group: In this group, common strengthening exercises of knee and hip muscles are performed for 7 weeks and with a frequency of three times a week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Neda Oraki far
Street address
Taleghani hospital, Saadat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
06134994433
Phone
+98 61 3554 0256
Email
Nedaorki@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Oraki far
Street address
Blv Golestan,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
15794 - 61357
Phone
+98 61 3311 0000
Email
nedaorki@yahoo.com
Grant name
Grant faculty members
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Oraki far
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, University of Medical Sciences, Golestan Blvd ,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3335 3600
Email
nedaoraki@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Neda Oraki far
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, University of Medical Sciences, Golestan Blvd ,Ahvaz Town
City
Ahvaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 61 3335 3600
Email
nedaoraki@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Maryam Kiani Haftlang
Position
Ms
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
TalegTaleghani hospital, Saadat Blvd, Padadshahr
City
Ahvaz
Province
Khouzestan
Postal code
06134994433
Phone
+98 61 3311 0000
Email
maryamkiani1371.hlg@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
the raw data of all participant will not be published.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
the raw data of all participant will not be published.
When the data will become available and for how long
the raw data of all participant will not be published.
To whom data/document is available
the raw data of all participant will not be published.
Under which criteria data/document could be used
the raw data of all participant will not be published.
From where data/document is obtainable
the raw data of all participant will not be published.
What processes are involved for a request to access data/document
the raw data of all participant will not be published.
Comments
the raw data of all participant will not be published.