Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Pain, Acute Clinical Trial

Official title:

Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05283434
• Other study ID #: 1812-139
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: July 15, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2022
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: Manu Madhok, MD, MPH
• Phone: 612-813-6843
• Email: manu.madhok[@]childrensmn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 324
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Myalgia
• Pain, Acute
• Pain, Muscle

Intervention

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.
• Placebo
Sugar pill placebo

Locations

Country	Name	City	State
United States	Children's Minnesota	Minneapolis	Minnesota
United States	Children's Minnesota	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (9)

Brinkhaus B, Wilkens JM, Lüdtke 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. Epub 2006 Oct 13. — View Citation

Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from http://www.ncbi.nlm.nih.gov/books/NBK501828/ — View Citation

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. Review. — View Citation

Karow JH, Abt HP, Fröhling 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. — View Citation

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 3(rd) Molars: A Pilot Study. Evid Based Complement Alternat Med. 2020 Dec 12;2020:6725175. doi: 10.1155/2020/6725175. eCollection 2020. — View Citation

Oberbaum M, Schreiber R, Rosenthal C, Itzchaki M. Homeopathic treatment in emergency medicine: a case series. Homeopathy. 2003 Jan;92(1):44-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Routine Change	The number of days the family's usual routine has been changed or disrupted following discharge	Three full days after discharge
Other	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
Other	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
Primary	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	Swelling	Swelling Measurement (cm)	Initial Emergency Department Visit to three full days after discharge
Secondary	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
Secondary	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