Conditions: Acute Low Back Pain
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 805
Healthy volunteers: no

Brief summary:
The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain.

Detailed description:

Arms:
arm 1: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 2: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 3: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period arm 4: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

Interventions: intervention 1: nicoboxil intervention 2: placebo matching nonivamide + nicoboxil intervention 3: nonivamide + nicoboxil (Finalgon) intervention 4: nonivamide
Intervention descriptions: intervention 1: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 2: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 3: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period intervention 4: 2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

Protocol document: