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

JRCT ID: jRCTs042230175

Registered date:21/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: chronic lower back pain
• Date of first enrollment: 21/03/2024
• Target sample size: 30
• Study type: Interventional

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)

Outcome(s)

• Primary Outcome: Visual analog scale (VAS)
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Imagama Shiro
• Source(s) of Monetary Support: i3 MEDICAL.inc