Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Sponsor

Children's Hospitals and Clinics of Minnesota (Other)

Overall Status

Recruiting

CT.gov ID

NCT05283434

Collaborator

(none)

324

Enrollment

Locations

Arms

23.5

Anticipated Duration (Months)

162

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Muscle Pain, Acute	Drug: Arnica Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Double-Blind Clinical TrialDouble-Blind Clinical Trial

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Arnica and the Management of Pain in Acute Musculoskeletal Extremity Injuries

Actual Study Start Date :

Jul 15, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	Drug: Placebo Sugar pill placebo
Experimental: Double-Blind Clinical Trial- Experimental Group	Drug: 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.

Arm

Intervention/Treatment

Placebo Comparator: 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.

Drug: Placebo

Sugar pill placebo

Experimental: Double-Blind Clinical Trial- Experimental Group

Drug: 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.

Outcome Measures

Primary Outcome Measures

Ibuprofen Dose [Initial Emergency Department Visit to three full days after discharge]
Amount of Ibuprofen the patient consumed during the three full days after discharge

Secondary Outcome Measures

Swelling [Initial Emergency Department Visit to three full days after discharge]
Swelling Measurement (cm)
Pain Score [Initial Emergency Department Visit to three full days after discharge]
Patient's Pain Score on a 1-10 scale where 1 is the lowest
Arnica Dosage [Within the first 24 hours of discharge]
The amount of Arnica doses (e.g., 2 pills) that were consumed; ranging from 1 to 4.

Other Outcome Measures

Routine Change [Three full days after discharge]
The number of days the family's usual routine has been changed or disrupted following discharge
Days of School/Work family members missed [Three full days after discharge]
The number of days of school and/or work days the patient's family missed after discharge
Days of School/Activities that a patient has missed [Three full days after discharge]
The number of days of school and/or activities the patient missed after discharge

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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