Clinical trial NCT05283434: Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
Official title: Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pain, Muscle
Pain, Acute
Keywords: Homeopathy
Pain Management
Musculoskeletal Extremity Injuries
Swelling
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 324
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-Blind Clinical Trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ibuprofen Dose
timeFrame: Initial Emergency Department Visit to three full days after discharge
Secondary outcomes:
measure: Swelling
timeFrame: Initial Emergency Department Visit to three full days after discharge
measure: Pain Score
timeFrame: Initial Emergency Department Visit to three full days after discharge
measure: Arnica Dosage
timeFrame: Within the first 24 hours of discharge
Other outcomes:
measure: Routine Change
timeFrame: Three full days after discharge
measure: Days of School/Work family members missed
timeFrame: Three full days after discharge
measure: Days of School/Activities that a patient has missed
timeFrame: Three full days after discharge
Locations:
city: Minneapolis
country: United States
facility: Children's Minnesota
state: Minnesota
city: Saint Paul
country: United States
facility: Children's Minnesota
state: Minnesota
Study officials:
affiliation: Children's Hospitals and Clinics of Minnesota
name: Manu Madhok, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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/
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 3rd Molars: A Pilot Study. Evid Based Complement Alternat Med. 2020 Dec 12;2020:6725175. doi: 10.1155/2020/6725175. eCollection 2020.
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.
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.
citation: 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.
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. doi: 10.1016/j.homp.2006.10.005.
citation: 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.