UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035347
Receipt number R000040272
Scientific Title Is adding mindfulness programme with exercise therapy better than exercise therapy alone for rehabilitation of runners with patellofemoral pain?
Date of disclosure of the study information 2019/01/17
Last modified on 2020/02/18 01:25:29

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Basic information

Public title

Is adding mindfulness programme with exercise therapy better than exercise therapy alone for rehabilitation of runners with patellofemoral pain?

Acronym

mindfulness programme and rehabilitation of runners with patellofemoral pain

Scientific Title

Is adding mindfulness programme with exercise therapy better than exercise therapy alone for rehabilitation of runners with patellofemoral pain?

Scientific Title:Acronym

mindfulness programme and rehabilitation of runners with patellofemoral pain

Region

Asia(except Japan)


Condition

Condition

Patellofemoral pain syndrome

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare the effects of mindfulness programme with exercise therapy and exercise therapy alone on the pain and knee function of runners with patellofemoral pain.

Basic objectives2

Others

Basic objectives -Others

1. Pain coping strategies
2. Pain related fear associated with avoidance behaviors
3. Catastrophizing
4. Physical performance

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1. Pain intensity
2. Knee disability
3. Pain coping strategies
4. Catastrophizing

Key secondary outcomes



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 therapy and mindfulness program

Interventions/Control_2

Exercise therapy

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

Female

Key inclusion criteria

Inclusion criteria: report a minimal weekly running distance of 15 km anterior or retropatellar knee pain from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping; insidious onset of symptoms unrelated to a traumatic incident presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat; positive Clarke's test; patella lateral displacement in patellar view radiography; age between 17 and 35 years; disease duration of more than 2 months; irresponsive to at least one month of conservative therapy.

Key exclusion criteria

Exclusion criteria: previous history of lumbosacral spine; pelvic or lower extremity surgery; history of severe knee trauma within the past 6 months; minor knee trauma within previous 2 months; symptoms of meniscal or other intraarticular pathologic conditions; evidence of a knee joint effusion or hip or lumbar referred pain; history of patellar dislocation; steroids consumption at time of inclusion; coagulopathies; systemic diseases such as rheumatoid arthritis, diabetes mellitus and dermatitis; presence of scar at the site of acupuncture; needle phobia; pregnancy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Aynollah
Middle name
Last name Aynollah Naderi

Organization

Shahrood University of Technology

Division name

Department of Health and Corrective Exercise, School of Sport Sciences

Zip code

3619995161

Address

Shahrood, Semnan, Iran

TEL

+989177217462

Email

ay.naderi@shahroodut.ac.ir


Public contact

Name of contact person

1st name Aynollah
Middle name
Last name Aynollah Naderi

Organization

Shahrood University of Technology

Division name

1Department of Health and Corrective Exercise, School of Sport Sciences

Zip code

3619995161

Address

Shahrood, Semnan, Iran

TEL

+989177217462

Homepage URL


Email

ay.naderi@shahroodut.ac.ir


Sponsor or person

Institute

Shahrood University of Technology
School of Sport Sciences

Institute

Department

Personal name



Funding Source

Organization

Shahrood University of Technology

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

Shahrood University of Technology

Address

Semnan Province, Shahroud

Tel

02332392204

Email

ay.naderi@shahroodut.ac.ir


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

2019 Year 01 Month 17 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


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

Enrolling by invitation

Date of protocol fixation

2018 Year 12 Month 20 Day

Date of IRB

2019 Year 01 Month 01 Day

Anticipated trial start date

2019 Year 01 Month 10 Day

Last follow-up date

2019 Year 05 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 12 Month 23 Day

Last modified on

2020 Year 02 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040272


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name