UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016211 |
|---|---|
| Receipt number | R000018798 |
| Scientific Title | Extra-articular knee pain and efficacy of tender-point stretching |
| Date of disclosure of the study information | 2015/01/15 |
| Last modified on | 2018/07/19 09:09:34 |
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Basic information
Public title
Extra-articular knee pain and efficacy of tender-point stretching
Acronym
Extra-articular knee pain and efficacy of tender-point stretching
Scientific Title
Extra-articular knee pain and efficacy of tender-point stretching
Scientific Title:Acronym
Extra-articular knee pain and efficacy of tender-point stretching
Region
| Japan |
Condition
Condition
Osteoarthritis (OA)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
(Phase 1) Confirm extra-articular pain is the mechanism for refractory pain resisted to standard treatments in OA knees. Examine and clarify anatomical points of extra-articular pain.
(Phase 2) Prove extra-articular pain is improved significantly by stretching the anatomical points of tenderness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
(Phase 1) Physical findings and patient-based subjective assessment before and after intra-articular hyaluronic acid injection.
(Phase 1) Physical findings and patient-based subjective assessment before and 3 months after intervention.
Key secondary outcomes
(Phase 1) Radiographic findings
(Phase 1) Simple patient-based subjective assessment 1.5 months after intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
(Phase 2a) Tender-point stretching 3 times a week on an outpatient basis.
Interventions/Control_2
(Phase 2a) Ultrasound stimulation 3 times a week on an outpatient basis.
Interventions/Control_3
(Phase 2b) Instruction for tender-point stretching at outpatient department and self-execution twice a day, 5 minutes each time.
Interventions/Control_4
(Phase 2b) Self application of idometacin cream twice a day.
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
Patients with knee pain resisted to conventional conservative treatments for more than 3 months.
Key exclusion criteria
No minor is included.
Patients with cognitive impairment and auditory disorder are excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyuki Koga |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-5803-4020
koga.orj@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Watanabe |
Organization
Tokyo Medical and Dental University
Division name
Department of Orthopaedic Surgery
Zip code
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL
03-5803-4020
Homepage URL
watanabe.orj@tmd.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
None
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
Secondary IDs
Secondary IDs
YES
Study ID_1
1899
Org. issuing International ID_1
Faculty of Medicine, Tokyo Medical and Dental University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京医科歯科大学医学部附属病院（東京都）
Tokyo Medical and Dental University Hospital of Medicine
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2015 | Year | 01 | Month | 14 | Day |
Last modified on
| 2018 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018798
