UMIN-CTR Clinical Trial

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 without apparent degenerative changes between the Mechanical Diagnosis and Therapy and drag 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 without apparent degenerative changes between the Mechanical Diagnosis and Therapy and drag 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 Kellgren Lawrence Grade 0-1
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 0-1, 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 Hiroshi Middle name Last name Takasaki
Organization	Saitama Prefectural University
Division name	Physical Therapy
Zip code	3438540
Address	Sannomiya 820, Koshigaya, Saitama
TEL	0489734706
Email	takasaki-hiroshi@spu.ac.jp

Public contact
Name of contact person	1st name Sanshiro Middle name Last name Hashimoto
Organization	Minami Shinjyuku Orthopedic Rehabilitation Clinic
Division name	Orthopedic
Zip code	1510053
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	Saitama Prefectural University
Address	Sannomiya 820, Koshigaya, Saitama
Tel	0489710500
Email	rinri@spu.ac.jp

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	0
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	2018 Year 06 Month 06 Day
Date of IRB	2018 Year 05 Month 31 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2021 Year 05 Month 17 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 06 Month 08 Day
Last modified on	2021 Year 05 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037536