Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-29 @ 3:09 AM
Study NCT ID:
NCT05283434
Status:
UNKNOWN
Last Update Posted:
2022-03-17
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063806', 'term': 'Myalgia'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059352', 'term': 'Musculoskeletal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712347', 'term': 'Arnicae flos extract'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-06-28', 'size': 282201, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-28T18:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Double-Blind Clinical Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 324}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-07', 'lastUpdatePostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Routine Change', 'timeFrame': 'Three full days after discharge', 'description': "The number of days the family's usual routine has been changed or disrupted following discharge"}, {'measure': 'Days of School/Work family members missed', 'timeFrame': 'Three full days after discharge', 'description': "The number of days of school and/or work days the patient's family missed after discharge"}, {'measure': 'Days of School/Activities that a patient has missed', 'timeFrame': 'Three full days after discharge', 'description': 'The number of days of school and/or activities the patient missed after discharge'}], 'primaryOutcomes': [{'measure': 'Ibuprofen Dose', 'timeFrame': 'Initial Emergency Department Visit to three full days after discharge', 'description': 'Amount of Ibuprofen the patient consumed during the three full days after discharge'}], 'secondaryOutcomes': [{'measure': 'Swelling', 'timeFrame': 'Initial Emergency Department Visit to three full days after discharge', 'description': 'Swelling Measurement (cm)'}, {'measure': 'Pain Score', 'timeFrame': 'Initial Emergency Department Visit to three full days after discharge', 'description': "Patient's Pain Score on a 1-10 scale where 1 is the lowest"}, {'measure': 'Arnica Dosage', 'timeFrame': 'Within the first 24 hours of discharge', 'description': 'The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Homeopathy', 'Pain Management', 'Musculoskeletal Extremity Injuries', 'Swelling'], 'conditions': ['Pain, Muscle', 'Pain, Acute']}, 'referencesModule': {'references': [{'pmid': '20105063', 'type': 'BACKGROUND', '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.'}, {'pmid': '12587994', 'type': 'BACKGROUND', '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.'}, {'pmid': '30000888', 'type': 'BACKGROUND', '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/'}, {'pmid': '33381206', 'type': 'BACKGROUND', '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.'}, {'pmid': '25171757', 'type': 'BACKGROUND', '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.'}, {'pmid': '18251757', 'type': 'BACKGROUND', '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.'}, {'pmid': '18199022', 'type': 'BACKGROUND', '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.'}, {'pmid': '17227743', 'type': 'BACKGROUND', '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.'}, {'pmid': '17105693', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '11 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient presents to the Emergency Department with an acute, soft tissue ankle or forearm injury\n* ED Provider orders an X-ray for evaluation of injury\n* Patient's initial pain score is of a 4 or higher\n* Patient has noticeable swelling at the site of the injury\n\nExclusion Criteria:\n\n* Patient is diagnosed with a fracture\n* Patient has an allergy to ibuprofen\n* 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)\n* Use of other concurrent complementary medicine therapy, e.g. massage, acupuncture, physical therapy\n* Patient has been treated for this injury in the past\n* Patient has a bleeding/bruising disorder\n* Patient is pregnant or is lactating\n* Patient has a liver or kidney disease, malignancy, infection, immunodeficiency or metabolic syndrome\n* Patient is allergic to the Asteraceae family of plants (arnica, ragweed, chrysanthemum, marigold, or daisy are the most common)\n* Patient is nonverbal, and thus unable to give a pain score\n* Patient does not have a working telephone (required for follow-up call)\n* Family requires foreign language interpreter during their ED visit"}, 'identificationModule': {'nctId': 'NCT05283434', 'briefTitle': 'Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospitals and Clinics of Minnesota"}, 'officialTitle': 'Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries', 'orgStudyIdInfo': {'id': '1812-139'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Double-Blind Clinical Trial- Placebo Group', 'description': '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.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Double-Blind Clinical Trial- Experimental Group', 'interventionNames': ['Drug: Arnica']}], 'interventions': [{'name': 'Arnica', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Double-Blind Clinical Trial- Experimental Group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sugar pill placebo', 'armGroupLabels': ['Double-Blind Clinical Trial- Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Manu Madhok, MD, MPH', 'role': 'CONTACT', 'email': 'manu.madhok@childrensmn.org', 'phone': '612-813-6822'}, {'name': 'Shea M Lammers, MS', 'role': 'CONTACT', 'email': 'shea.lammers@childrensmn.org', 'phone': '763-478-1548'}, {'name': 'Manu Madhok, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Manu Madhok, MD, MPH', 'role': 'CONTACT', 'email': 'manu.madhok@childrensmn.org', 'phone': '612-813-6822'}, {'name': 'Shea M Lammers, MS', 'role': 'CONTACT', 'email': 'shea.lammers@childrensmn.org', 'phone': '763-478-1547'}], 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'centralContacts': [{'name': 'Manu Madhok, MD, MPH', 'role': 'CONTACT', 'email': 'manu.madhok@childrensmn.org', 'phone': '612-813-6843'}, {'name': 'Shea M Lammers, MS', 'role': 'CONTACT', 'email': 'shea.lammers@childrensmn.org', 'phone': '763-478-1547'}], 'overallOfficials': [{'name': 'Manu Madhok, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan in place to make individual participant data available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Physician', 'investigatorFullName': 'Manu Madhok', 'investigatorAffiliation': "Children's Hospitals and Clinics of Minnesota"}}}}