UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042906
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email aoisekkotsuin@hotmail.co.jp

Sponsor
Institute True Treat Group INc.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048866

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.