UMIN-CTR Clinical Trial

Basic information
Public title	Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Acronym	Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Scientific Title	Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Scientific Title:Acronym	Effects of Exercises and electrical muscle stimulation on pain, knee kinematic and lower extremity performance in Handball athletes suffering patellofemoral pain syndrome
Region	Asia(except Japan)

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

Objectives
Narrative objectives1	All narrative objectives were appropriate.
Basic objectives2	Others
Basic objectives -Others	Rehabilitation, prevention
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS scale (pain intensity) was assessed before and after intervention
Key secondary outcomes	Knee valgus kinematic and performance were assessed

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and 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	Other
Interventions/Control_1	Exercise plus EMS suit, Exercises for eight weeks, three times a week, the duration of each training session was 45-60 minutes. The training protocol consisted of 16 exercises.
Interventions/Control_2	Exercise without EMS suit, Exercises for eight weeks, three times a week, the duration of each training session was 45-60 minutes. The training protocol consisted of 16 exercises.
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	(1) symptoms of anterior knee pain for at least 1 month and (2) average pain level of 4 or more on a 10-cm visual analogue scale during squatting with the diagnosis of an experienced physiotherapist (3) presence of 2 of the following clinical criteria on assessment.
Key exclusion criteria	(1) 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).
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Hadi Middle name Last name Mohammadi Nia Samakosh
Organization	Kharazmi university
Division name	Khu
Zip code	14911-15719
Address	Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL	989336487376
Email	shahramsamakosh92@yahoo

Public contact
Name of contact person	1st name Hadi Middle name Last name Mohammadi Nia Samakosh
Organization	Kharazmi university
Division name	Khu
Zip code	14911-15719
Address	Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
TEL	989336487376
Homepage URL	https://www.linkedin.com/in/hadi-shahram-mohammadi-nia-samakosh-308091194
Email	shahramsamakosh92@yahoo

Sponsor
Institute	Kharazmi university
Institute
Department

Funding Source
Organization	Kharazmi university
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Kharazmi university
Address	Mirdamad, South Razan Street, Hesari Street, Keshvari Sport complex, Tehran, Iran.
Tel	989336487376
Email	shahramsamakosh92@yahoo

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	2023 Year 06 Month 06 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	44
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 11 Month 01 Day
Date of IRB	2021 Year 11 Month 10 Day
Anticipated trial start date	2021 Year 11 Month 23 Day
Last follow-up date	2022 Year 01 Month 29 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 03 Month 23 Day
Last modified on	2022 Year 03 Month 23 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053907