NCT05283434

Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Children's Hospitals and Clinics of Minnesota · Academic / Other
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

In the Emergency Department, there is no standard of care for pain medication distribution for children with an acute musculoskeletal injury when there is no fracture present. Currently, ibuprofen is a favorable choice for the treatment, but studies have shown concern for delayed healing activity associated with NSAIDs like Ibuprofen. Homeopathic Arnica Montana is a well-established complimentary medicine and may provide a good alternative for managing acute pain from musculoskeletal injuries, especially in children, given the palatability and rarity of side effects. This study aims to compare usual care vs. usual care plus Arnica 1M\* (oral) or the placebo for management of pain in acute musculoskeletal extremity injuries without fracture by utilizing a double-blind clinical trial design. The primary outcome is to determine if subjects use less ibuprofen when given Arnica 1M.

Conditions

• Pain, Muscle
• Pain, Acute

Interventions

Type	Name	Description
DRUG	Arnica	Patients will be assigned to the placebo (e.g., unmedicated sugar pill) or experimental group (e.g., Arnica 1M pellets) via a randomization chart from that only the research pharmacist will have access to. Subjects assigned to the experimental group will take the recommended doses of Arnica 1M coated sugar pellets (i.e., 2 pills to be taken every 4 waking hours over a 24 hours period), and will track their pain scores, swelling measurements, sleep rate, ibuprofen doses, adverse reactions, further ED visits, and the number of days/activities the patient has missed for 3 days following their enrollment in the study.
DRUG	Placebo	Sugar pill placebo

Timeline

• Start date: 2021-07-15
• Primary completion: 2023-06-30
• Completion: 2023-06-30
• First posted: 2022-03-17
• Last updated: 2022-03-17

Locations

2 sites across 1 country: United States