Pain, Acute Clinical Trial
Official title:
Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Minnesota | Minneapolis | Minnesota |
United States | Children's Minnesota | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Children's Hospitals and Clinics of Minnesota |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05396820 -
Adaptation of the Motor System to Experimental Pain
|
N/A | |
Completed |
NCT04356963 -
Adjunct VR Pain Management in Acute Brain Injury
|
N/A | |
Recruiting |
NCT06350084 -
Effect of Mother's Touch and Nurse's Therapeutic Touch on Pain Level and Crying Time During Heel Blood Collection
|
N/A | |
Completed |
NCT04080037 -
Assessing Opioid Care Practices Using CPV Patient Simulation Modules
|
N/A | |
Recruiting |
NCT05458037 -
RCT of Pain Perception With Fast and Slow Tenaculum Application
|
N/A | |
Completed |
NCT04571515 -
Dose-Response Study of MR-107A-01 in The Treatment of Post-Surgical Dental Pain
|
Phase 2 | |
Completed |
NCT06005480 -
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
|
Phase 1 | |
Active, not recruiting |
NCT04850079 -
EHR Precision Drug Treatment in Neonates
|
||
Completed |
NCT03271151 -
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
|
Phase 4 | |
Completed |
NCT03272139 -
Interscalene Block Versus Superior Trunk Block
|
Phase 4 | |
Recruiting |
NCT05383820 -
Effect of Paracetamol and Ketorolac on RANK-L Levels in Patients Starting Orthodontic Treatment
|
Phase 4 | |
Completed |
NCT04851353 -
Multiple Sensory Interventions On Infants' Pain and Physiological Distress During Neonatal Screening Procedures
|
N/A | |
Completed |
NCT03280017 -
Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain
|
Phase 4 | |
Completed |
NCT04280796 -
Changes in Affective Pain Processing in Human Volunteers
|
N/A | |
Not yet recruiting |
NCT04491630 -
COping With PAin Through Hypnosis, Mindfulness and Spirituality
|
N/A | |
Not yet recruiting |
NCT04523623 -
Pain Control Differences Between Oxycodone and Ibuprofen in Children With Isolated Forearm Injuries
|
N/A | |
Not yet recruiting |
NCT04062513 -
Olfactive Stimulation Interventions With Mothers' Milk on Preterm Pain Response
|
N/A | |
Withdrawn |
NCT03137030 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of Different Amounts of Tablets of a New and a Marketed Tablet Formulation in Healthy Adults
|
Phase 1 | |
Withdrawn |
NCT03137017 -
A Comparison of Plasma Concentrations of Hydrocodone and Acetaminophen After Administration of a New and a Marketed Tablet Formulation Under Fasted and Fed Conditions in Healthy Adults
|
Phase 1 | |
Completed |
NCT04659395 -
How to Develop a Training Program for Nurses in Ultrasound Guided Femoral Nerve Block
|
N/A |