Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Acute; Pain, Muscle
• Intervention / Treatment: Drug: Placebo; Drug: Arnica

• Study Type: Interventional
• Enrollment (Anticipated): 324
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Manu Madhok, MD, MPH; Phone Number: 612-813-6843; Email: manu.madhok@childrensmn.org
• Study Contact Backup: Name: Shea M Lammers, MS; Phone Number: 763-478-1547; Email: shea.lammers@childrensmn.org

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55404
      • Recruiting
      • Children's Minnesota
      • Contact: Manu Madhok, MD, MPH; Phone Number: 612-813-6822; Email: manu.madhok@childrensmn.org
      • Contact: Shea M Lammers, MS; Phone Number: 763-478-1548; Email: shea.lammers@childrensmn.org
      • Principal Investigator: Manu Madhok, MD, MPH
    • Saint Paul, Minnesota, United States, 55102
      • Recruiting
      • Children's Minnesota
      • Contact: Shea M Lammers, MS; Phone Number: 763-478-1547; Email: shea.lammers@childrensmn.org
      • Contact: Manu Madhok, MD, MPH; Phone Number: 612-813-6822; Email: manu.madhok@childrensmn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Placebo; Sugar pill placebo
Experimental: Double-Blind Clinical Trial- Experimental Group	Drug: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Routine Change	The number of days the family's usual routine has been changed or disrupted following discharge	Three full days after discharge
Days of School/Work family members missed	The number of days of school and/or work days the patient's family missed after discharge	Three full days after discharge
Days of School/Activities that a patient has missed	The number of days of school and/or activities the patient missed after discharge	Three full days after discharge

Collaborators and Investigators

• Sponsor: Children's Hospitals and Clinics of Minnesota
• Investigators: Principal Investigator: Manu Madhok, MD, MPH, Children's Hospitals and Clinics of Minnesota

Publications and helpful links

General Publications

• Iannitti T, Morales-Medina JC, Bellavite P, Rottigni V, Palmieri B. Effectiveness and Safety of Arnica montana in Post-Surgical Setting, Pain and Inflammation. Am J Ther. 2016 Jan-Feb;23(1):e184-97. doi: 10.1097/MJT.0000000000000036.
• Thompson EA, Bishop JL, Northstone K. The use of homeopathic products in childhood: data generated over 8.5 years from the Avon Longitudinal Study of Parents and Children (ALSPAC). J Altern Complement Med. 2010 Jan;16(1):69-79. doi: 10.1089/acm.2009.0007.
• Oberbaum M, Schreiber R, Rosenthal C, Itzchaki M. Homeopathic treatment in emergency medicine: a case series. Homeopathy. 2003 Jan;92(1):44-7. doi: 10.1054/homp.2002.0071.
• Arnica. 2021 May 17. Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from http://www.ncbi.nlm.nih.gov/books/NBK501828/
• Mawardi H, Ghazalh S, Shehatah A, Abdelwahid A, Aljohani A, Felemban O, Almazrooa S, Elbadawi L, Shawky H. Systemic Use of Arnica Montana for the Reduction of Postsurgical Sequels following Extraction of Impacted Mandibular 3rd Molars: A Pilot Study. Evid Based Complement Alternat Med. 2020 Dec 12;2020:6725175. doi: 10.1155/2020/6725175. eCollection 2020.
• Paris A, Gonnet N, Chaussard C, Belon P, Rocourt F, Saragaglia D, Cracowski JL. Effect of homeopathy on analgesic intake following knee ligament reconstruction: a phase III monocentre randomized placebo controlled study. Br J Clin Pharmacol. 2008 Feb;65(2):180-7. doi: 10.1111/j.1365-2125.2007.03008.x.
• Karow JH, Abt HP, Frohling M, Ackermann H. Efficacy of Arnica montana D4 for healing of wounds after Hallux valgus surgery compared to diclofenac. J Altern Complement Med. 2008 Jan-Feb;14(1):17-25. doi: 10.1089/acm.2007.0560.
• Robertson A, Suryanarayanan R, Banerjee A. Homeopathic Arnica montana for post-tonsillectomy analgesia: a randomised placebo control trial. Homeopathy. 2007 Jan;96(1):17-21. doi: 10.1016/j.homp.2006.10.005.
• Brinkhaus B, Wilkens JM, Ludtke R, Hunger J, Witt CM, Willich SN. Homeopathic arnica therapy in patients receiving knee surgery: results of three randomised double-blind trials. Complement Ther Med. 2006 Dec;14(4):237-46. doi: 10.1016/j.ctim.2006.04.004. Epub 2006 Oct 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 7, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (Actual): March 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 17, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Homeopathy; Pain Management; Swelling; Musculoskeletal Extremity Injuries
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Acute Pain
• Other Study ID Numbers: 1812-139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is no plan in place to make individual participant data available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No