UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047921 |
|---|---|
| Receipt number | R000054632 |
| 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 |
| Date of disclosure of the study information | 2022/06/02 |
| Last modified on | 2022/06/01 23:03:14 |
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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
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
letafatkaramir@yahoo.com
Sponsor or person
Institute
"NO"
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054632
