Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Study Overview
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Brief Summary
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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.

Official Title
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Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Conditions
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Pain, Muscle, Pain, Acute

Intervention / Treatment
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* Drug: Arnica
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-Blind Clinical Trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Double-Blind Clinical Trial- Placebo Group<br>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. | Drug: Placebo<br>* Sugar pill placebo<br>|
| Experimental: Double-Blind Clinical Trial- Experimental Group<br> | Drug: Arnica<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ibuprofen Dose | Amount of Ibuprofen the patient consumed during the three full days after discharge | Initial Emergency Department Visit to three full days after discharge | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Homeopathy, Pain Management, Musculoskeletal Extremity Injuries, Swelling