UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Acronym	Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Scientific Title	Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Scientific Title:Acronym	Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Region	Asia(except Japan)

Condition
Condition	pretesr-posttest
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of Exercise and Electrical Muscle Stimulation on Pain, Disability, Knee Kinematic and Lower Extremity Performance in Handball Athletes Suffering Patellofemoral Pain Syndrome
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain Disability
Key secondary outcomes	Single-Leg Landing Task (Kinematic) Single Leg Hop Test

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	exercise with EMS
Interventions/Control_2	exercise without EMS
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	30 years-old >=
Gender	Male and Female
Key inclusion criteria	symptoms of anterior knee pain for at least one month; (2) average pain level of four or more on a 10-cm visual analogue scale during squatting; and (3) presence of two of the following clinical criteria on assessment: pain during apprehension test, pain during the patellar compression test, and crepitation during the compression test and completing the consent form
Key exclusion criteria	any history of knee surgery; (2) history of patellar dislocation or subluxation or ligament laxity; (3) orthopedic and nerve injuries; (4) history of other abnormalities such as leg length inequalities (> 2 cm); and (5) medication as a part of the treatment 50. Participants were also excluded from the study if they underwent other types of therapy, specific work activities, or regular treatments (e.g., stretching, tape, braces, orthoses and/or acupuncture) or if they failed in two consecutive sessions or three non-consecutive sessions, n = 1 male) or if they failed in the post-test phase (n = 1 male)
Target sample size	44

Research contact person
Name of lead principal investigator	1st name amir Middle name Last name letafatkar
Organization	Kharazmi Univrsity
Division name	Sport medicine
Zip code	6664743
Address	tehran
TEL	00989195394692
Email	letafatkaramir@yahoo.com

Public contact
Name of contact person	1st name amir Middle name Last name letafatkar
Organization	Kharazmi University
Division name	sport medicine
Zip code	6664743
Address	tehran
TEL	00989357465993
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	"NO"
Institute
Department

Funding Source
Organization	self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethics Committee of the Polytechnic Institute of Santarem, Portugal (N6-2022ESDRM)
Address	Portugal
Tel	2322 7250
Email	rafaeloliveira@esdrm.ipsantarem.pt

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	42
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2021 Year 02 Month 02 Day
Date of IRB	2021 Year 09 Month 02 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 01 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054632