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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032924
Receipt No. R000037535
Scientific Title Is there a difference in recurrence of knee pain between the Mechanical Diagnosis and Therapy and drag intervention: randomized controlled trial
Date of disclosure of the study information 2018/06/15
Last modified on 2018/06/08

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Basic information
Public title Is there a difference in recurrence of knee pain between the Mechanical Diagnosis and Therapy and drag intervention: randomized controlled trial
Acronym Is there a difference in recurrence of knee pain associated with degenerative changes between the McKenzie approach and etodolac intervention: randomized controlled trial
Scientific Title Is there a difference in recurrence of knee pain between the Mechanical Diagnosis and Therapy and drag intervention: randomized controlled trial
Scientific Title:Acronym Is there a difference in recurrence of knee pain associated with degenerative changes between the McKenzie approach and etodolac intervention: randomized controlled trial
Region
Japan

Condition
Condition Knee pain
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine if there are differences in treatment effects and recurrence rate between interventions with McKenzie approach and etodolac for patients with knee pain and the KellgrenLawrence Grade 2-4
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time for recurrence
Key secondary outcomes Flexion/extension range of motion using a goniometer (pre intervention; 1, 2, 3, 4, 5, 6, 7, 8, 11 and 14 months after the initiation of the intervention)
Subjective pain in tensity (P4) (pre intervention; and 1, 2, 3, 4, 5, 6, 7, 8, 11 and 14 months after the initiation of the intervention)
Quality of life (EQ5D)(pre intervention; and 1, 2, 3, 4, 5, 6, 7, 8, 11 and 14 months after the initiation of the intervention)
Subjective disability (Patient Specific Functional Scale & Knee Injury and Osteoarthritis Outcome Score) (pre intervention; and 1, 2, 3, 4, 5, 6, 7, 8, 11 and 14 months after the initiation of the intervention)
Treatment effect (Global Rating Recovery Scale) (1, 2, 3, 4, 5, 6, 7, 8, 11 and 14 months after the initiation of the intervention)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but 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
Medicine Maneuver
Interventions/Control_1 8-week intervention with McKenzie approach
Interventions/Control_2 etodolac x 2/day [200mg/day] for 8 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria Outpatients coming to the Minami Shinjyuku Orthopedic Rehabilitation Clinic
Kellgren Lawrence grade of 2-4, confirmed by an orthopaedic surgeon
No contraindication for the use of etodolac
Knee pain lasting for more than 1 month with the intensity of 4 or more in the 0-10 numerical rating scale
Key exclusion criteria Symptoms or movement impairments on the lower leg originated from tissues other than the knee
Communication difficulties in Japanese
Outpatients for the post-surgical management
History of the Around the Knee Osteotomy or the Total Knee Arthroplasty
Target sample size 60

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

Public contact
Name of contact person
1st name
Middle name
Last name Sanshiro Hashimoto
Organization Minami Shinjyuku Orthopedic Rehabilitation Clinic
Division name Orthopedic
Zip code
Address 16-7, Yoyogi 2, Sibuya, Tokyo
TEL 0353020790
Homepage URL
Email sansho@msorc.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
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
2018 Year 06 Month 15 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 Preinitiation
Date of protocol fixation
2018 Year 06 Month 06 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 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 06 Month 08 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037535

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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