Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Children's Hospitals and Clinics of Minnesota

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pain, Muscle; Pain, Acute

Treatments: Drug: Arnica; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05283434

1812-139

Details and patient eligibility

About

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.

Enrollment: 324 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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324 participants in 2 patient groups, including a placebo group

Double-Blind Clinical Trial- Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Double-Blind Clinical Trial- Experimental Group

Experimental group

Treatment:

Drug: Arnica