Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05137041 | Efficacy and Safety of FIRTECH in Patients With Mild to Moderate Acute Low Back Pain | PHASE3 | COMPLETED | 221 | — | — | Nov 4, 2021 | Nov 22, 2022 | Sep 9, 2025 | 7 | Germany, Italy |
NRS is used to assess pain intensity, it is a 11-point scale (0-10) where '0' representing 'no pain' and '10' representing 'worst pain imaginable'. Responder is defined as participant with ≥30% decrease from baseline in pain NRS and who did not take rescue medication (defined as receiving paracetamol (authorized), any other analgesics and anti-inflammatory drugs as well as any non-pharmaceutical therapy (prohibited) for treating pain starting from randomization to Day 5 or starting before the study and still ongoing at randomization).
| Arm | Type | Description |
|---|---|---|
| ITP FIRTECH | EXPERIMENTAL | The ITP FIRTECH patch was applied on the lower back region of the body on Day 1 and intended to be worn for 5 Days (Day 5). |
| No Patch Control Arm | NO_INTERVENTION | No patch application. |
| Name | Type | Description |
|---|---|---|
| ITP FIRTECH | DEVICE | Infrared Therapy Patch |
Inclusion Criteria: * Participants suffering from mild to moderate acute low back pain * Low back pain (lumbar back pain) is defined as pain in the back from the level of the lowest rib down to the gluteal fold * Acute episode is defined as acute pain with less than 1 month duration * With intensit...