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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023181
Receipt No. R000026722
Scientific Title Safety evaluation of abdominal trunk muscle training for chronic low back pain
Date of disclosure of the study information 2016/07/15
Last modified on 2018/07/17

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Basic information
Public title Safety evaluation of abdominal trunk muscle training for chronic low back pain
Acronym Safety evaluation of abdominal trunk muscle training for chronic low back pain
Scientific Title Safety evaluation of abdominal trunk muscle training for chronic low back pain
Scientific Title:Acronym Safety evaluation of abdominal trunk muscle training for chronic low back pain
Region
Japan

Condition
Condition chronic nonspecific low back pain
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the initial safety of exercise equipment for trunk muscle strength measurement and training that was developed in our department.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The number of expression adverse events, side effects after the start of treatment.
Key secondary outcomes Improvement rate of low back pain NRS after enforcement treatment for 12 weeks. Analgesic use number of times change, JOABPEQ improvement rate, RDQ improvement rate, the amount of change in the trunk muscle strength measurements using an equivalent instrument, locomotive syndrome degree of improvement rate, changes in the eye-opening piece stepladder position time.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Subjects and Methods: Of our hospital 65 years of age or older of low back pain patients who are attending to, be diagnosed by chronic low back pain and the doctor followed the onset more than three months, to target the 10 people who do not fit the exclusion criteria.
A wash-out period of two weeks of preparation period, combination therapy start to then provided. After the guidance and preparation period of two weeks for training methods, to conduct training in a week to three times visits to a physiotherapist by guidance of the original. After the end of treatment of a total of 12 weeks, usually carried out in the conservative medical treatment (oral, injection, rehabilitation, etc.).
Training is focusing on the abdominal and trunk muscles in a state in which the pressure was moderately pressure to the belt of the exercise equipment, to resist the pressure of the belt. Strength at this time is adjusted in such a way that about 60 percent of each person's maximum measured value in the same instrument. Every 5 seconds to put the force and loosen repeatedly, it continued for 10 minutes per set. Conducted a total of two sets, it is recorded in the diary.
Interventions/Control_2
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The subjects must meet all of the following criteria
1)Patient age at the time of obtaining informed consent is a full 65 years of age or older.
2)Patients from more than three months followed by chronic low back pain and a doctor from the onset received a diagnosis.
3)Patients who showed in the Numerical Rating Scale (NRS) related to low back pain, three or more of the value before the start of the study.
4)Patients after receiving a sufficient explanation Upon this test participation, on a sufficient understanding, the document agreed by the free will of the patient himself was obtained.
5)Out patient.
6)Patients physical therapist of this Institute study responsibility (shared) and a good command without problems the training to do for the study deems
Key exclusion criteria Patients conflict with one of the following shall be not be incorporated in the study
1)Have heart disease, kidney disease, respiratory disease, blood disease, coagulation disorders and other serious complications, the patient is determined to be inappropriate by the attending physician.
2)The patient is poor understanding of the study due to dementia.
3)Patients with severe neurological symptoms, such as paralysis.
4)Patients with spinal surgical history
5)Patients with a diagnosis by a doctor as having specific lower back pain.
6)Patients with rheumatoid arthritis
7)Patients with a high degree of osteoporosis (such as fragility fracture history).
8)Other, patient research responsibility (sharing) who is determined to be unsuitable as a subject.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kato
Organization Kanazawa University Hospital
Division name Rehabilitation
Zip code
Address 13-1,Takaramachi,Kanazawa-shi,Ishikawa-ken
TEL 076-265-2374
Email skato323@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naoki Takahashi
Organization Kanazawa University Hospital
Division name Orthopaedic Surgery
Zip code
Address 13-1,Takaramachi,Kanazawa-shi,Ishikawa-ken
TEL 076-265-2374
Homepage URL
Email t_hashi1005@yahoo.co.jp

Sponsor
Institute Department of Orthopaedic Surgery, Kanazawa University Hospital
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2016 Year 07 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 Completed
Date of protocol fixation
2016 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 07 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
2016 Year 07 Month 15 Day
Last modified on
2018 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026722

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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