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Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Primary Purpose

Pain, Muscle, Pain, Acute

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Arnica
Placebo
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Muscle focused on measuring Homeopathy, Pain Management, Musculoskeletal Extremity Injuries, Swelling

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's MinnesotaRecruiting
  • Children's MinnesotaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Double-Blind Clinical Trial- Placebo Group

Double-Blind Clinical Trial- Experimental Group

Arm 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.

Outcomes

Primary Outcome Measures

Ibuprofen Dose
Amount of Ibuprofen the patient consumed during the three full days after discharge

Secondary Outcome Measures

Swelling
Swelling Measurement (cm)
Pain Score
Patient's Pain Score on a 1-10 scale where 1 is the lowest
Arnica Dosage
The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.

Full Information

First Posted
March 7, 2022
Last Updated
March 7, 2022
Sponsor
Children's Hospitals and Clinics of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05283434
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 15, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Muscle, Pain, Acute
Keywords
Homeopathy, Pain Management, Musculoskeletal Extremity Injuries, Swelling

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double-Blind Clinical Trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
324 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double-Blind Clinical Trial- Placebo Group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Double-Blind Clinical Trial- Experimental Group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Arnica
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill placebo
Primary Outcome Measure Information:
Title
Ibuprofen Dose
Description
Amount of Ibuprofen the patient consumed during the three full days after discharge
Time Frame
Initial Emergency Department Visit to three full days after discharge
Secondary Outcome Measure Information:
Title
Swelling
Description
Swelling Measurement (cm)
Time Frame
Initial Emergency Department Visit to three full days after discharge
Title
Pain Score
Description
Patient's Pain Score on a 1-10 scale where 1 is the lowest
Time Frame
Initial Emergency Department Visit to three full days after discharge
Title
Arnica Dosage
Description
The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.
Time Frame
Within the first 24 hours of discharge
Other Pre-specified Outcome Measures:
Title
Routine Change
Description
The number of days the family's usual routine has been changed or disrupted following discharge
Time Frame
Three full days after discharge
Title
Days of School/Work family members missed
Description
The number of days of school and/or work days the patient's family missed after discharge
Time Frame
Three full days after discharge
Title
Days of School/Activities that a patient has missed
Description
The number of days of school and/or activities the patient missed after discharge
Time Frame
Three full days after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manu Madhok, MD, MPH
Phone
612-813-6843
Email
manu.madhok@childrensmn.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shea M Lammers, MS
Phone
763-478-1547
Email
shea.lammers@childrensmn.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manu Madhok, MD, MPH
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manu Madhok, MD, MPH
Phone
612-813-6822
Email
manu.madhok@childrensmn.org
First Name & Middle Initial & Last Name & Degree
Shea M Lammers, MS
Phone
763-478-1548
Email
shea.lammers@childrensmn.org
First Name & Middle Initial & Last Name & Degree
Manu Madhok, MD, MPH
Facility Name
Children's Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manu Madhok, MD, MPH
Phone
612-813-6822
Email
manu.madhok@childrensmn.org
First Name & Middle Initial & Last Name & Degree
Shea M Lammers, MS
Phone
763-478-1547
Email
shea.lammers@childrensmn.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan in place to make individual participant data available to other researchers.
Citations:
PubMed Identifier
20105063
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.
Results Reference
background
PubMed Identifier
12587994
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.
Results Reference
background
PubMed Identifier
30000888
Citation
Arnica. 2021 May 17. 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/
Results Reference
background
PubMed Identifier
33381206
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.
Results Reference
background
PubMed Identifier
25171757
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.
Results Reference
background
PubMed Identifier
18251757
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.
Results Reference
background
PubMed Identifier
18199022
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.
Results Reference
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PubMed Identifier
17227743
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.
Results Reference
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PubMed Identifier
17105693
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.
Results Reference
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Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

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