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

Phase 3

• Conditions: Acute Low Back Pain; acute, low back pain; D017116

• Registration Number: JPRN-jRCT2032190209
• Lead Sponsor: Miki Kenji

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-13
• Study Completion: 2021-01-05
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion 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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified