UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027824 |
|---|---|
| Receipt number | 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 10:12:12 |
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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
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
takasaki-hiroshi@spu.ac.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
Minami Shinjuku Orthopedic Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031881
