Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
NCT ID: NCT05283434
Last Updated: 2022-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
324 participants
INTERVENTIONAL
2021-07-15
2023-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Placebo
Sugar pill placebo
Double-Blind Clinical Trial- Experimental Group
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.
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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
11 Years
18 Years
ALL
Yes
Sponsors
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Children's Hospitals and Clinics of Minnesota
OTHER
Responsible Party
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Manu Madhok
Physician
Principal Investigators
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Manu Madhok, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Children's Hospitals and Clinics of Minnesota
Locations
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Children's Minnesota
Minneapolis, Minnesota, United States
Children's Minnesota
Saint Paul, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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. 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/
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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1812-139
Identifier Type: -
Identifier Source: org_study_id
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