Pain, Muscle, Pain, Acute
Conditions
Keywords
Homeopathy, Pain Management, Musculoskeletal Extremity Injuries, Swelling
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.
Interventions
DRUGArnica
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.
DRUGPlacebo
Sugar pill placebo
Sponsors
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Double-Blind Clinical Trial
Eligibility
Sex/Gender
ALL
Age
11 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Days of School/Work family members missed | Three full days after discharge | The number of days of school and/or work days the patient's family missed after discharge |
| Days of School/Activities that a patient has missed | Three full days after discharge | The number of days of school and/or activities the patient missed after discharge |
| Routine Change | Three full days after discharge | The number of days the family's usual routine has been changed or disrupted following discharge |
Countries
United States
Contacts
Primary ContactManu Madhok, MD, MPH
Backup ContactShea M Lammers, MS
Outcome results
None listed