Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Last updated: March 7, 2022
Sponsor: Children's Hospitals and Clinics of Minnesota
Overall Status: Active - Recruiting

Phase

2/3

Condition

Acute Pain

Pain

Muscle Pain

Treatment

N/A

Clinical Study ID

NCT05283434
1812-139
  • Ages 11-18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient presents to the Emergency Department with an acute, soft tissue ankle orforearm 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

Exclusion Criteria:

  • Patient is diagnosed with a fracture
  • Patient has an allergy to ibuprofen
  • Patient is already on a NSAID, acetaminophen, anticoagulant or oral corticosteroidtherapy for chronic pain treatment (a NSAID given in triage or use for the currentinjury 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 ormetabolic 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

Study Design

Total Participants: 324
Study Start date:
July 15, 2021
Estimated Completion Date:
June 30, 2023

Connect with a study center

  • Children's Minnesota

    Minneapolis, Minnesota 55404
    United States

    Active - Recruiting

  • Children's Minnesota

    Saint Paul, Minnesota 55102
    United States

    Active - Recruiting

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