UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040272