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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000027824
Receipt No. R000031881
Scientific Title Treatment effect of interventions using mechanical loading to people with primary complaint of knee pain
Date of disclosure of the study information 2017/06/19
Last modified on 2017/12/19

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Basic information
Public title Treatment effect of interventions using mechanical loading to people with primary complaint of knee pain
Acronym Three-arm randomized control trial of exercise intervention for the lumbar spine, exercise intervention for the knee and NSAID intervention for people with knee pain, whose Mechanical Diagnosis and Therapy subgroup of derangement syndrome in the lumbar spine
Scientific Title Treatment effect of interventions using mechanical loading to people with primary complaint of knee pain
Scientific Title:Acronym Three-arm randomized control trial of exercise intervention for the lumbar spine, exercise intervention for the knee and NSAID intervention for people with knee pain, whose Mechanical Diagnosis and Therapy subgroup of derangement syndrome in the lumbar spine
Region
Japan

Condition
Condition People with primary complaint of knee pain, whose Mechanical Diagnosis and Therapy subgroup of derangement syndrome in the lumbar spine
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate weather individuals with knee pain, who respond to mechanical loading to the spine, do not respond to other interventions or not
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The Global Rating Recovery Scale will be evaluated at 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the initial intervention.
Key secondary outcomes Range of knee flexion/extension, the P4, the EQ-5D, the Patient Specific Functional Scale, and the Knee Injury and Osteoarthritis Outcome Score will be evaluated before the initial intervention and at 2 weeks, 4 weeks, 6 weeks, and 8 weeks after the initial intervention.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eight-week intervention with mechanical loading to the lumbar spine along with the directional preference
Interventions/Control_2 Four-week intervention with mechanical loading to the knee and then 4-week intervention with mechanical loading to the lumbar spine along with the directional preference
Interventions/Control_3 Four-week intervention with prescription of NSAID and then 4-week intervention with mechanical loading to the lumbar spine along with the directional preference
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

Not applicable
Gender Male and Female
Key inclusion criteria Primary complain of knee pain lasting for more than one month
Improvement of the knee by mechanical loading to the lumbar spine
Key exclusion criteria Kellgren-Lawrence grade 4
Not being eligible to exercise therapy or manual therapy
Purpose for post-surgical management
Not being able to obtain a written consent from the participant
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Division of Physical Therapy
Zip code
Address Sannomiya 820, Koshigaya, Saitama, Japan
TEL 0489734706
Email takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Takasaki
Organization Saitama Prefectural University
Division name Division of Physical Therapy
Zip code
Address Sannomiya 820, Koshigaya, Saitama, Japan
TEL 0489734706
Homepage URL
Email takasaki-hiroshi@spu.ac.jp

Sponsor
Institute Saitama Prefectural University
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Minami Shinjuku Orthopedic Clinic
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
2017 Year 06 Month 19 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 Terminated
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 23 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
2017 Year 06 Month 19 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031881

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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