Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

NCT05283434 | Unknown Phase 2 DMC

• 1 other identifier: 1812-139
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 2

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

Keywords

Homeopathy; Pain Management; Musculoskeletal Extremity Injuries; Swelling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Swelling

  Initial Emergency Department Visit to three full days after discharge

• Pain Score

  Initial Emergency Department Visit to three full days after discharge

• Arnica Dosage

  Within the first 24 hours of discharge

Other Outcomes (3)

• Routine Change

  Three full days after discharge

• Days of School/Work family members missed

  Three full days after discharge

• Days of School/Activities that a patient has missed

  Three full days after discharge

Study Arms (2)

Double-Blind Clinical Trial- Placebo Group

PLACEBO COMPARATOR

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

Double-Blind Clinical Trial- Experimental Group

EXPERIMENTAL

Drug: Arnica

Interventions

Arnica DRUG

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.

Double-Blind Clinical Trial- Experimental Group

Placebo DRUG

Sugar pill placebo

Double-Blind Clinical Trial- Placebo Group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead

Study Sites (2)

Children's Minnesota

Minneapolis, Minnesota, 55404, United States

RECRUITING

Children's Minnesota

Saint Paul, Minnesota, 55102, United States

RECRUITING

Related Publications (9)

• 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.

  PMID: 20105063 BACKGROUND

• 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.

  PMID: 12587994 BACKGROUND

• Arnica. 2024 Oct 15. Drugs and Lactation Database (LactMed(R)) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Available from http://www.ncbi.nlm.nih.gov/books/NBK501828/

  PMID: 30000888 BACKGROUND

• 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.

  PMID: 33381206 BACKGROUND

• 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.

  PMID: 25171757 BACKGROUND

• 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.

  PMID: 18251757 BACKGROUND

• 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.

  PMID: 18199022 BACKGROUND

• 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.

  PMID: 17227743 BACKGROUND

• 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.

  PMID: 17105693 BACKGROUND

MeSH Terms

Conditions

Myalgia; Acute Pain; Agnosia

Interventions

Arnicae flos extract

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Manu Madhok, MD, MPH

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manu Madhok, MD, MPH

CONTACT

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

Shea M Lammers, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Double-Blind Clinical Trial

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 17, 2022
• Study Start: July 15, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: March 17, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)