Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Phase 2

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Patient presents to the Emergency Department with an acute, soft tissue ankle or forearm injury
ED Provider orders an X-ray for evaluation of injury
Patient's initial pain score is of a 4 or higher
Patient has noticeable swelling at the site of the injury

Exclusion Criteria

Patient is diagnosed with a fracture
Patient has an allergy to ibuprofen
Patient is already on a NSAID, acetaminophen, anticoagulant or oral corticosteroid therapy for chronic pain treatment (a NSAID given in triage or use for the current injury is allowed)
Use of other concurrent complementary medicine therapy, e.g. massage, acupuncture, physical therapy
Patient has been treated for this injury in the past
Patient has a bleeding/bruising disorder
Patient is pregnant or is lactating
Patient has a liver or kidney disease, malignancy, infection, immunodeficiency or metabolic syndrome
Patient is allergic to the Asteraceae family of plants (arnica, ragweed, chrysanthemum, marigold, or daisy are the most common)
Patient is nonverbal, and thus unable to give a pain score
Patient does not have a working telephone (required for follow-up call)
Family requires foreign language interpreter during their ED visit

Arm && Interventions

Group	Intervention	Description
Double-Blind Clinical Trial- Experimental Group	Arnica	-
Double-Blind Clinical Trial- Placebo Group	Placebo	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 placebo group will take the recommended doses of 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.

Primary Outcome Measures

Name	Time	Method
Ibuprofen Dose	Initial Emergency Department Visit to three full days after discharge	Amount of Ibuprofen the patient consumed during the three full days after discharge

Secondary Outcome Measures

Name	Time	Method
Swelling	Initial Emergency Department Visit to three full days after discharge	Swelling Measurement (cm)
Pain Score	Initial Emergency Department Visit to three full days after discharge	Patient's Pain Score on a 1-10 scale where 1 is the lowest
Arnica Dosage	Within the first 24 hours of discharge	The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.

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