UMIN-CTR Clinical Trial

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

chronic nonspecific low back pain

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Orthopaedic Surgery, Kanazawa University Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

07

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

07

Month

15

Day

Last modified on

2018

Year

07

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026722