UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032923 |
|---|---|
| Receipt number | R000037534 |
| 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 | 2021/05/17 10:24:52 |
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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 Mechanical Diagnosis and Therapy and drag intervention: randomized controlled pilot 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 Mechanical Diagnosis and Therapy and drag intervention: randomized controlled pilot trial
Region
| Japan |
Condition
Condition
Knee pain
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate feasibility of a randomized controlled trial to examine if there are differences in treatment effects and recurrence rate between interventions with Mechanical Diagnosis and Therapy and NSAID for patients with knee pain and the Kellgren Lawrence Grade 2-4
Basic objectives2
Others
Basic objectives -Others
Feasibility
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Recruitment rate of the participants per month
Key secondary outcomes
Drop-out rate
The number of intervention sessions of Mechanical Diagnosis and Therapy for 8 weeks (1 and 2 months after the initiation of the intervention)
Exercise compliance in the mechanical Diagnosis and Therapy arm for 8 weeks
Treatment stages for the derangement syndrome in Mechanical Diagnosis and Therapy arm (reduction of derangement, maintain of the reduced derangement, recovery of function, education and maintenance) (1 and 2 months after the initiation of the intervention)
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)
Time for recurrence
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 Mechanical Diagnosis and Therapy
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
20
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
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
sansho@msorc.jp
Sponsor or person
Institute
Saitama Prefectural University
Institute
Department
Personal name
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
Koshigaya Sannnomiya 820
Tel
0489710500
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037534
