Recruiting
Phase 2
Phase 3

Arnica

Sponsor:

Children's Hospitals and Clinics of Minnesota

Code:

NCT05283434

Conditions

Pain, Muscle

Pain, Acute

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

Interventions

Arnica

Placebo

Study Details

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.

Conditions

Pain, Muscle

Pain, Acute

Study ID

NCT05283434

Start date

Jul 15, 2021

Status verified date

Mar, 2022

Completion date

Jun 30, 2023

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 18

Healthy Volunteers: Accepted

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

Study Design

Enrollment

324 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Double-Blind Clinical Trial- Placebo Group

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.

experimental: Double-Blind Clinical Trial- Experimental Group

Interventions

Arnica

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.

Placebo

Sugar pill placebo

Primary outcome measure

  • Ibuprofen Dose [ Time Frame: Initial Emergency Department Visit to three full days after discharge ]

Central Contacts and Locations

Central contacts

Manu Madhok, MD, MPH

612-813-6843manu.madhok@childrensmn.org

Shea M Lammers, MS

763-478-1547shea.lammers@childrensmn.org

Locations

Children's Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Manu Madhok, MD, MPH

612-813-6822manu.madhok@childrensmn.org

Shea M Lammers, MS

763-478-1548shea.lammers@childrensmn.org

Principal Investigator:

Manu Madhok, MD, MPH

Children's Minnesota

Recruiting

Saint Paul, Minnesota, United States, 55102

Contacts

Manu Madhok, MD, MPH

612-813-6822manu.madhok@childrensmn.org

Shea M Lammers, MS

763-478-1547shea.lammers@childrensmn.org

More Information

Sponsor

Children's Hospitals and Clinics of Minnesota

Last update posted

Mar 17, 2022

Last verified

Mar, 2022

Keywords

  • Homeopathy
  • Pain Management
  • Musculoskeletal Extremity Injuries
  • Swelling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospitals and Clinics of Minnesota on 2022-03-17.