A Multicenter, Prospective, Open Label, Single-Arm Study of a Novel Pain Management Device, AT-04, in Patients with Acute Low Back Pain

JRCT ID: jRCT2032190209

Registered date:13/02/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acute Low Back Pain
• Date of first enrollment: 17/03/2020
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Use AT-04 (magnetic field pain management device) at least once daily for at least 30 minutes at a time. However, the total time of usage per day should not exceed 2 hours. The pads of AT-04 can be applied to up to 4 painful areas simultaneously in a single treatment.

Outcome(s)

• Primary Outcome: It will be verified whether the difference between the VAS score at the time of formal registration and the VAS score on the last day of the treatment period meets the performance goal specified separately.
• Secondary Outcome: Scores on the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at baseline (at formal registration) and last day.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

(1) Age: Patients aged >= 20 to < 80 years (at the time of informed consent)
(2) Patients with VAS value >= 40 mm and time from onset of >= 4 weeks to < 3 months
(3) Patients who have not received the treatment for acute low back pain or who have received the treatment for acute low back pain without any change in the treatment regimen (including the prescription, dosage and administration) during the 14 days before formal registration
(4) Patients with no changes in the degree of pain during the 14 days before formal registration
(5) Patients not requiring hospitalization for treatment
(6) Patients for whom written consent can be obtained directly from the patient

Exclude criteria

(1) Patients who have findings of spinal disease other than low back pain and who also have pain attributable to the disease
(2) Patients with a history of surgery for spinal or lumbar disease
(3) Patients with psychiatric disease that is known to affect the measurement of pain
(4) Patients for whom treatment of underlying diseases clearly causing pain such as trauma and arthritis (rheumatic, osteoarthritis and infectious) should be prioritized
(5) Patients who are using life-supporting medical electrical equipment such as a heart-lung machine or a pacemaker
(6) Patients using wearable medical electrical equipment such as electrocardiograph
(7) Patients with a history of drug abuse (including alcohol)
(8) Patients with intractable pain whose VAS value is 40 mm or higher despite simultaneous administration of 3 or more of the following drugs: weak opioids such as tramadol, pregabalin, Cymbalta, or Tryptanol
(9) Patients who are participating in clinical studies of other drugs or medical devices
(10) Patients requiring hospitalization for treatment
(11) Patients with dementia severely interfering with daily life
(12) Women who wish to become pregnant or are pregnant or lactating (a pregnancy test should be performed if there is a possibility of pregnancy)

Related Information

• Primary Sponsor: Miki Kenji