The use of injectable treatments in the management of acute muscle strains

In athletes with acute hamstring tears, is injection of Traumeel effective in reduction of time lost to training in comparison to placebo (saline) injection?

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615000768594

Enrollment

Registered

2015-07-24

Start date

2015-09-08

Completion date

2015-09-08

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Muscle tears are a common injury in athletic populations. This exploratory study will involve a randomised trial comparing the effects of Traumeel with placebo in the treatment of acute muscle strains, specifically those of the hamstring muscles. This substance is used extensively in Europe for treatment of muscle injuries, however, there is no available evidence base for the use of these treatments. Due to this lack of evidence these treatments are not offered as standard practice to Australian athletes. Investigating these treatments that may provide additional options for injured athletes is a priority in reducing training days lost to injury.

Interventions

Traumeel injection - ultrasound guided, single, intramuscular injection of 4mL of Traumeel S solution into the muscle tear of the intervention group. Active ingredients of Traumeel: Achillea millefolium (Homeopathic) 1 mg/mL Aconitum napellus (Homeopathic) 600 microgram/mL Arnica montana (Homeopathic) 1 mg/mL Atropa belladonna (Homeopathic) 1 mg/mL Bellis perennis (Homeopathic) 500 microgram/mL Calcium sulfide (Homeopathic) 1 mg/mL Calendula officinalis (Homeopathic) 1 mg/mL Echinacea angustifolia (Homeopathic) 250 microgram/mL Echinacea purpurea (Homeopathic) 250 microgram/mL Hamamelis virginiana (Homeopathic) 100 microgram/mL Hypericum perforatum (Homeopathic) 300 microgram/mL Matricaria chamomilla (Homeopathic) 1 mg/mL Mercury - Hahnemann's soluble (Homeopathic) 500 microgram/mL Symphytum officinale (Homeopathic) 1 mg/mL

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

Male

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

Recreational athletes with acute hamstring injury occurring during explosive activity, within 96 hours of presentation.

Exclusion criteria

Elite athletes, and those with a pacemaker, neurostimulator, cochlear implant, metal chips in the eye or extreme claustrophobia, due to the MRI procedure involved to assess initial hamstring injury. Those with a needle phobia, due to injection being the only method of drug delivery

Outcome results