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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Double-Blind Clinical Trial- Experimental Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manu Madhok, MD, MPH | Contact | 612-813-6843 | manu.madhok@childrensmn.org | |
| Shea M Lammers, MS | Contact | 763-478-1547 | shea.lammers@childrensmn.org |
| Name | Affiliation | Role |
|---|---|---|
| Manu Madhok, MD, MPH | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Minnesota | Recruiting | Minneapolis | Minnesota | 55404 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20105063 | Background | 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. | |
| 12587994 | 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. |
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There is no plan in place to make individual participant data available to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 28, 2021 | Jul 28, 2021 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D063806 | Myalgia |
| D059787 | Acute Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000712347 | Arnicae flos extract |
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Double-Blind Clinical Trial
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|
| Placebo | Drug | Sugar pill placebo |
|
| 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 |
| 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 |
| Children's Minnesota | Recruiting | Saint Paul | Minnesota | 55102 | United States |
|
| 30000888 | 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/ |
| 33381206 | 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. |
| 25171757 | 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. |
| 18251757 | 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. |
| 18199022 | 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. |
| 17227743 | 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. |
| 17105693 | 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. |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |