臨床研究等提出・公開システム

Japanese

Date of registration	Mar. 21, 2024
Last modified on	Feb. 05, 2025
Trial ID	jRCTs042230175

Scientific Title	The Study of the Effectiveness of a Digital Care Program for Chronic Low Back Pain
Public Title	The Study of the Effectiveness of a Digital Care Program for Chronic Low Back Pain

Contact for Scientific Queries	Name	Imagama Shiro
	Affiliation	Nagoya university graduate school of medicine
	Address	65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
	Telephone	+81-52-741-2111
	E-mail	imagama@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Ito Sadayuki
	Affiliation	Nagoya university graduate school of medicine
	Address	65 Tsurumai-cho, Showa-ku, Nagoya city, Aichi prefecture
	Telephone	+81-52-741-1908
	E-mail	sadaito@med.nagoya-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Mar. 21, 2024
Actual date of first enrollment
Target sample size		30
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with chronic low back pain who do not require surgery Persons who are able to obtain free and voluntary written consent to participate in the research Adults who are at least 18 years of age at the time consent is obtained Regardless of gender
	Exclusion Criteria	Patients with a history of lumbar spine surgery or those indicated for lumbar spine surgery Patients who are eligible for surgery Patients who cannot give consent to recording audio or video when using a tablet Patients who are deemed unsuitable by the physician
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		chronic lower back pain
Intervention(s)		A tablet (SMARIHA PRO) will be loaned free of charge to subjects whose consent has been obtained. The physical therapist who conducts the remote interview determines the content of the exercise to be performed, and the digital care program is automatically activated at the scheduled date and time of the three weekly sessions. In addition, during the 12-week study period, remote interviews will be conducted with the physical therapist once a week to confirm the exercise content based on the assessment of motor function and to confirm that the exercise therapy is being performed safely. Translated with www.DeepL.com/Translator (free version)
Health Condition(s) Keyword		low pack pain, sciatica
Intervention(s) Keyword		exercise
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Visual analog scale (VAS)
Secondary Outcome(s)		Japanese Orthopaedic Association Back Pain Evaluation Questionnaire: JOABPEQ, Adherence to exercise therapy (implementation and completion rates), Patient Health Questionnaire-9 (PHQ-9)PHQ-9), Generalized Anxiety Disorder -7 (GAD-7)

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	i3 MEDICAL.inc
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Nagoya University Clinical Research Review Board
Address	65 Tsurumai-cho,Showak-ku,Nagoya city,Aichi,JAPAN, Aichi
Telephone	+81-52-744-2479
E-Mail	ethics@med.nagoya-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 27, 2023

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 05, 2025	(this page)	Changes
2	April. 19, 2024	Detail	Changes
1	Mar. 21, 2024	Detail

List of change history