UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044439
Receipt number R000050768
Scientific Title effect of education and stabilization training in patients with patellofemoral pain
Date of disclosure of the study information 2021/06/05
Last modified on 2021/06/05 03:13:14

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Basic information

Public title

effect of education and stabilization training in patients with patellofemoral pain

Acronym

effect of education and stabilization training in patients with patellofemoral pain

Scientific Title

effect of education and stabilization training in patients with patellofemoral pain

Scientific Title:Acronym

effect of education and stabilization training in patients with patellofemoral pain

Region

Asia(except Japan)


Condition

Condition

pre post intervention

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

effect of education and stabilization training in patients with patellofemoral pain

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain

Key secondary outcomes

function;pain catastrophizing;kinesiophobia;muscle strength


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Medicine

Interventions/Control_1

Patient education + Stablization training

Interventions/Control_2

Stablization training

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

18 years-old <=

Age-upper limit

40 years-old >=

Gender

Male and Female

Key inclusion criteria

Persian-native speaker male and female;aged between 18 and 40 years;primary complaint of the anterior knee and the symptoms of PFP;anterior knee pain of 3 or greater on the 10-cm visual analogue scale (VAS) for a minimum of 8 weeks before participation;anterior knee pain when performing at least two of the following activities: prolonged sitting;squatting, kneeling, running, climbing and descending stairs

Key exclusion criteria

surgery and /or intra-articular pathology in any lower limb joint;patellar instability;knee joint effusion;Osgood-Schlatter or Sinding Larsen-Johansson syndrome;referred pain coming from the lumbar spine, hips;ankles, or feet;and having physiotherapy treatment for PFP up to 3 months before participating

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Pouya
Middle name
Last name Rabiei

Organization

Islamic Azad University

Division name

Sport medicine

Zip code

6664743

Address

tehran

TEL

00989195394692

Email

pouya.rabiei.pr@gmail.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 or person

Institute

Kharazmi university

Institute

Department

Personal name



Funding Source

Organization

"Kharazmi university"

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

Sport science research center

Address

tehran

Tel

00982188747884

Email

ssri.ethics.c@gmail.com


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

2021 Year 06 Month 05 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

60

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

2020 Year 07 Month 06 Day

Date of IRB

2021 Year 06 Month 04 Day

Anticipated trial start date

2021 Year 01 Month 01 Day

Last follow-up date

2021 Year 06 Month 17 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 05 Day

Last modified on

2021 Year 06 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050768


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name