UMIN-CTR Clinical Trial

Public title

A Study on the Effects of Functional Training Combining an Occupational Therapy Approach and Educational Programs Aimed at Improving Chronic Low Back Pain in Senior Day Care Center Users, Examined Through Brain Activity

Acronym

Brain Study on Chronic Low Back Pain Education

Scientific Title

Electrophysiological Investigation of the Effectiveness of a Functional Training Intervention Using Patient Education and Occupational Therapy Approaches for Chronic Low Back Pain Patients in Senior Day Care Center Users

Scientific Title:Acronym

Chronic Low Back Pain OT-EEG Study

Region

Japan

Condition

Chronic Low Back Pain

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Approximately 85% of chronic lower back pain cases are classified as non-specific as there are no specific physiological factors. In recent years, chronic low back pain and chronic widespread pain have come to be seen as pain modulation pain that is caused by functional changes in the brain, and it is thought that visualizing the plasticity of the brain nerves and exploring the neural mechanisms of pain will contribute to the development of effective treatment methods and recovery strategies. In the chronic pain treatment guidelines, exercise therapy combined with patient education and occupational therapy is stated to have a small to medium effect on chronic pain and is generally recommended as an intervention, but the physiological mechanisms of this are not clear. Electroencephalography (EEG) is attracting attention as a non-invasive and cost-effective method for evaluating temporal changes in pain. We analyzed open EEG data from the Technical University of Munich and found that the current source density of theta and delta waves in the frontal region of patients with chronic low back pain correlated with subjective pain indicators. PGV Corporation's wearable EEG HARU-2 is a device that can measure frontal EEG easily and inexpensively, and it has been certified as a medical device (No.304AFBZX00012000) and has high safety and high accuracy as a medical device. Using this device, this study will measure the frontal EEG of chronic back pain sufferers and investigate the effects of functional training interventions using patient education and occupational therapy approaches for chronic back pain sufferers in day-care nursing care, longitudinally. This will examine whether frontal EEG can be used as an objective indicator of pain, and will aim to contribute to the development of effective treatment methods and recovery strategies.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I,II

Primary outcomes

Pain-related disability: Pain Disability Index
Pain quality: PainDETECT, Short Form McGill Pain Questionnaire; SF-MPQ
Current pain intensity: NRS (0=no pain, 10=worst imaginable pain)

Key secondary outcomes

General cognitive function: MMSE-J
Geriatric depression: Geriatric Depression Scale 15; GDS15
Average pain intensity over the past 4 weeks: NRS (0=no pain, 10=worst possible pain)
Resting frontal EEG: Wearable EEG (HARU-2)
Anxiety: State-Trait Anxiety Inventory; STAI

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

The participants receives a total of 8 sessions of regular rehabilitation exercises and functional training for strengthening the muscles of the lower limbs and trunk once a week, followed by 8 sessions of patient education and occupational therapy-based intervention once a week, and then another 8 sessions of regular functional training once a week.
EEG measurements and pain and anxiety assessments are also carried out, and the intervention lasts for 15 minutes. The specific content of the intervention includes pain education using patient education materials such as the "Guidebook on Pain and Stiffness Caused by Hormone Therapy", "Pain Guidebook: What You Need to Know about Central Sensitization", and "Pain Guidebook: What You Need to Know about the Neuroscience of Pain", as well as ADL guidance and goal setting. This information is provided to participants in the form of a PowerPoint presentation, and after that, there is a discussion between the participants and the research team members about the educational content, and finally, a simple test is conducted to check the participants' understanding of the educational content. Before the intervention, the participants' pain, ADL, and cognitive function are fully evaluated, and a patient education and occupational therapy approach that is suitable for each participant is considered.

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

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

A user of a day service center, with a mean intensity of back pain of 4 or more points (0=no pain, 10=worst possible pain) on the Numerical Rating Scale (NRS) over the past 4 months, and a Mini-Mental State Examination -Japanese version- (MMSE-J) score of 24 or more, who has freely chosen to participate in the study, and who has had the purpose and content of the study explained to them verbally and in writing by the principal investigator or a member of the research team, and who has signed the consent form distributed to them.

Key exclusion criteria

Age 64 or under, or 91 or over
MMSE-J score of 23 or less
Average intensity of low back pain in the past 4 months of 3 or less

Target sample size

10

Name of lead principal investigator

1st name	Yasuo
Middle name
Last name	Naito

Organization

Osaka Metropolitan University

Division name

Graduate School of Rehabilitation Science

Zip code

583-8555

Address

3-7-30 Habikino, Habikino-City,Osaka

TEL

072-950-2111

Email

naitoh@omu.ac.jp

Name of contact person

1st name	Keita
Middle name
Last name	Ueno

Organization

Osaka Metropolitan University

Division name

Graduate School of Rehabilitation Science

Zip code

583-8555

Address

3-7-30 Habikino, Habikino-City,Osaka

TEL

072-950-2111

Homepage URL

Email

keitaueno@omu.ac.jp

Institute

Osaka Metropolitan University

Institute

Department

Personal name

Yasuo Naito

Organization

Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Osaka Metropolitan University Graduate School of Rehabilitation Sciences Committee on Research Ethics

Address

3-7-30 Habikino, Habikino-City,Osaka

Tel

072-950-2111

Email

gr-hab-shinsa@omu.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

Date of disclosure of the study information

2025

Year

03

Month

01

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

2024

Year

12

Month

03

Day

Date of IRB

Anticipated trial start date

2025

Year

03

Month

01

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

02

Month

07

Day

Last modified on

2025

Year

01

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064952