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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035347
Receipt No. 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 2019/02/06

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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
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
Address Shahrood, Semnan, Iran
TEL +989177217462
Email ay.naderi@shahroodut.ac.ir

Public contact
Name of contact person
1st name
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
Address Shahrood, Semnan, Iran
TEL +989177217462
Homepage URL
Email ay.naderi@shahroodut.ac.ir

Sponsor
Institute Shahrood University of Technology
School of Sport Sciences
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2019 Year 01 Month 10 Day
Last follow-up date
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
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.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


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