UMIN-CTR Clinical Trial

Public title

Verification of the Effectiveness of Far-Infrared Blood Circulation-Promoting Garments in Reducing Low Back Pain in Chronic Low Back Pain Cases

Acronym

Verification of the Effectiveness of Far-Infrared Blood Circulation-Promoting Garments in Reducing Low Back Pain in Chronic Low Back Pain Cases

Scientific Title

A Double-Blind, Parallel-Group, Randomized Controlled Trial on the Effects of Far-Infrared Blood Circulation-Promoting Garments on Trunk Function and Low Back Pain in Individuals with Chronic Nonspecific Low Back Pain

Scientific Title:Acronym

A Double-Blind, Parallel-Group, Randomized Controlled Trial on the Effects of Far-Infrared Blood Circulation-Promoting Garments on Trunk Function and Low Back Pain in Individuals with Chronic Nonspecific Low Back Pain

Region

Japan

Condition

Non-specific chronic low back pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Non-specific chronic low back pain refers to low back pain lasting over three months with no identifiable cause. Because the cause is unknown, treatment for non-specific chronic low back pain is often difficult and tends to become intractable. It is known that pain can cause changes in trunk muscle activity, abnormal stiffness, and reduced spinal mobility. There is a need for interventions to improve pain and functional impairment in such patients with non-specific chronic low back pain.
Recently, far-infrared blood circulation-promoting garments have gained attention after being approved as general medical devices. The blood-circulation-promoting effect of far-infrared rays may help improve symptoms such as fatigue and muscle stiffness. However, general medical devices are defined as having little risk to human life or health, even if side effects or functional impairments occur. Therefore, the efficacy of these garments in alleviating symptoms in cases of nonspecific chronic low back pain is not yet fully established.
This study aims to verify the intervention effects of wearing far-infrared blood circulation-promoting garments on lumbar back muscle tissue stiffness and function, spinal mobility, and low back pain in individuals with chronic nonspecific low back pain.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Questionnaire regarding low back pain before intervention, 2 weeks after, and 4 weeks after (Numerical rating scale: NRS, Oswestry disability index: ODI)

Key secondary outcomes

Spinal alignment and mobility assessment using Spinal Mouse, multifidus muscle thickness assessment using ultrasound imaging equipment, and spinal erector muscle tissue stiffness assessment using MyotonePRO before intervention, 2 weeks after, and 4 weeks after

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Other

Interventions/Control_1

The intervention group wears innerwear with far-infrared blood circulation promotion effects for at least 8 hours daily during daytime hours for 4 weeks.
The control group wears innerwear without far-infrared blood circulation promotion effects for at least 8 hours daily during daytime hours for 4 weeks.

Interventions/Control_2

The intervention group performed 10 to 15 minutes of trunk muscle exercises daily for 4 weeks while wearing innerwear with far-infrared blood circulation promotion effects.
The control group performed 10 to 15 minutes of trunk muscle exercises daily for 4 weeks while wearing innerwear without far-infrared blood circulation promotion effects, identical to the intervention group.

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

40

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

Individuals experiencing low back pain on three or more days per week for three months or longer

Key exclusion criteria

Individuals who can touch the floor with their palms during the standing forward bend test, cannot agree to refrain from initiating other pain relief therapies during the trial period, are pregnant or may be pregnant, have recently given birth or are breastfeeding, may exhibit allergic symptoms to the test product material, with skin abnormalities such as wounds, eczema, or irritation in areas where the test product will come into contact, with organic diseases such as herniated discs, experiencing numbness in the hands or feet, with a history of identified structural spinal abnormalities, with acute (painful) conditions such as spinal fractures or muscle strains, who have participated in another clinical trial within the past month or are currently participating in one, with a BMI of 28 or higher, presently receiving prescription medication for internal medical conditions, who cannot consent to the publication of trial footage for promotional purposes in a manner that prevents personal identification (e.g., by obscuring the face), currently receiving outpatient treatment for low back pain.

Target sample size

84

Name of lead principal investigator

1st name	Akimi
Middle name
Last name	Nakata

Organization

Morinomiya University of Medical Sciences

Division name

Department of Physical Therapy, Faculty of Rehabilitation

Zip code

559-8611

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka

TEL

06-6616-6911

Email

akimi_nakata@morinomiya-u.ac.jp

Name of contact person

1st name	Yoshihiro
Middle name
Last name	Maekawa

Organization

Morinomiya University of Medical Sciences

Division name

Department of Medical Technology, Faculty of Medical Science Technology

Zip code

559-8611

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka

TEL

06-6616-6911

Homepage URL

Email

kenkyu@morinomiya-u.ac.jp

Institute

Morinomiya University of Medical Sciences

Institute

Department

Personal name

Akimi Nakata

Organization

MTG Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Morinomiya University of Health Sciences Research Ethics Review Board

Address

1-26-16 Nankokita, Suminoe-ku, Osaka-shi, Osaka

Tel

06-6616-6911

Email

kenkyu@morinomiya-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

森ノ宮医療大学（大阪府）

Date of disclosure of the study information

2026

Year

01

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

Preinitiation

Date of protocol fixation

2025

Year

11

Month

11

Day

Date of IRB

2025

Year

12

Month

26

Day

Anticipated trial start date

2026

Year

01

Month

23

Day

Last follow-up date

2026

Year

03

Month

15

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

14

Day

Last modified on

2026

Year

01

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069045