UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042906 |
|---|---|
| Receipt number | R000048866 |
| Scientific Title | Survey on the relationship between lower back pain, knee pain, and hip pain and lower limb alignment based on the ankle joint |
| Date of disclosure of the study information | 2021/01/05 |
| Last modified on | 2021/01/05 12:10:34 |
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Basic information
Public title
Research on the effects of ankle and other joint conditions on the whole body, including chronic back pain
Acronym
Research on the effects of joints on the human body
Scientific Title
Survey on the relationship between lower back pain, knee pain, and hip pain and lower limb alignment based on the ankle joint
Scientific Title:Acronym
Association of the ankle with nonspecific low back, knee, and hip pain
Region
| Japan |
Condition
Condition
low back pain, knee pain, hip pain
Classification by specialty
| Not applicable | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of ankle and other lower limb joint alignment on the natural recovery of back, knee and hip pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate whether ankle-based lower limb joint alignment is effective for low back pain, knee pain, and hip pain by dividing the patients into two groups: one with joint alignment and the other with major conservative therapy without joint alignment, and collecting statistics on recovery status at 1 week, 2 weeks, and less than 1 month, respectively. The deadline will be one month. Spontaneous recovery status will also be compared for specific and non-specific low back pain.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Subjects with specific and non-specific low back pain, hip pain, and knee pain will be randomly divided into four groups (Group A, Group B, Group C, and Group D) according to age, gender, height, and weight.
Group A has specific low back pain, and in addition to conventional conservative therapy, alignment adjustment of the lower limb joints starting from the ankle will be performed. The frequency of adjustment will be determined at the convenience of the subject.
Interventions/Control_2
Group B has specific low back pain and will receive only conventional conservative therapy without lower limb joint alignment. The frequency of participation will also be at the subject's convenience.
The time limit will be one month, and the recovery status will be calculated after one week, two weeks, and less than one month of the study, respectively.
Interventions/Control_3
Group C has non-specific low back pain, and in addition to conventional conservative therapy, lower limb joint alignment starting from the ankle will be performed. The frequency of participation is also up to the subject.
Interventions/Control_4
Group D will have non-specific low back pain and will receive only conventional conservative therapy without lower limb joint alignment. The frequency of participation is also up to the subject.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 5 | years-old | <= |
Age-upper limit
| 97 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
People with either specific or non-specific back, knee, or hip pain.
Key exclusion criteria
(1) Those who did not agree to the survey policy after it was explained to them (2) Those who are not suitable for alignment due to severe deformity (3) Those who have specific low back pain and are prohibited from approaching the low back.
Target sample size
962
Research contact person
Name of lead principal investigator
| 1st name | Noriomi |
| Middle name | |
| Last name | Tsunoda |
Organization
TrueTreatGroup Inc.
Division name
True Treat GINZA
Zip code
104-0061
Address
3-11-19 Ginza,Chu-ou ku,Tokyo,Japan
TEL
03-6264-3372
aoisekkotsuin@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Noriomi |
| Middle name | |
| Last name | Tsunoda |
Organization
True Treat Group, Inc.
Division name
True Treat GINZA
Zip code
104
Address
3-11-19 Ginza,Chu-ou ku,Tokyo,Japan
TEL
03-6264-3372
Homepage URL
aoisekkotsuin@hotmail.co.jp
Sponsor or person
Institute
True Treat Group INc.
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2021 | Year | 01 | Month | 05 | 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
962
Results
Group A 394 patients
Less than 1 week 89
Less than 1 week 98
Less than 1 month 149
No change within 1 month 58
Group B 394 patients
Less than 1 week 297
Less than 1 week 68
Less than 1 month 26
No change within 1 month 5
Remaining number of patients with specific low back pain
Translated with www.DeepL.com/Translator (free version)
Results date posted
| 2020 | Year | 12 | Month | 21 | Day |
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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
| 1977 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048866
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| Registered date | File name |
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