臨床研究等提出・公開システム

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

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

30

The average age was 50.5 years old (22-76 years old). The enrolled subjects were 13 men and 17 women.

First patient in: 2020.Mar.17 Last patient in: 2020.Nov.26 Last patient out: 2021.Jan.5 Discontinued patients: 0 Subjects for efficacy analysis: 30

Dental caries: 1 case Medical device site reaction: 4 cases Nasopharyngitis: 2 cases Animal bite: 1 case Ligament sprain: 1 case The all adverse events were non-serious.

The mean difference between the VAS score at the time of formal registration and the VAS score on the last day of the treatment period was 36.95 mm, and the lower limit of the 95% confidence interval was 28.40 mm and met the performance goal specified separately. And, in the scores on the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) which is a secondary endpoint, the scores of all items were maintained or improved on the last day compared to the at baseline (at formal registration).

The efficacy and safety of AT-04 in clinical use were demonstrated and it was judged the goal of this clinical study was achieved.

Nov. 30, 2023

No

https://jrct.mhlw.go.jp/latest-detail/jRCT2032190209

Miki Kenji

Hayaishi Hospital

2-75 Fudegasaki Tennoji, Osaka, Japan 543-0027

kenji-miki@umin.ac.jp

Guto In

Peace of Mind Co., Ltd.

2-8-6 Tokuo Kita-ku, Kumamoto-city, Japan 861-5525

+81-96-352-9600

pm@jomdd.com

Complete

Feb. 20, 2020

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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

(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)

Both

Acute Low Back Pain

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.

acute, low back pain

Magnetic Field Therapy

D017116

D055909

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.

Scores on the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at baseline (at formal registration) and last day.

Feb. 13, 2020

none