Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000768594
Ethics application status
Approved
Date submitted
4/06/2015
Date registered
24/07/2015
Date last updated
7/09/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of injectable treatments in the management of acute muscle strains
Scientific title
In athletes with acute hamstring tears, is injection of Traumeel effective in reduction of time lost to training in comparison to placebo (saline) injection?
Secondary ID [1] 286850 0
Nil
Universal Trial Number (UTN)
U1111-1170-9348
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hamstring Muscle Strain 295243 0
Condition category
Condition code
Musculoskeletal 295489 295489 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 295576 295576 0 0
Physiotherapy
Alternative and Complementary Medicine 295577 295577 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 292017 0
Treatment: Drugs
Comparator / control treatment
Placebo injection - ultrasound guided, intramuscular injection of 4mL of normal saline solution, 0.9% sodium chloride
Control group
Placebo

Outcomes
Primary outcome [1] 295222 0
Return to Sport - return to full play.
Participants will be asked to report the date when they returned to full, unhampered training. This date will be reported in terms of days post injury and comparison will be made between treatment and control groups
Timepoint [1] 295222 0
6 weeks post intervention
Secondary outcome [1] 315104 0
Active Knee Extension (AKE) test
Difference in degrees of leg extension between injured and uninjured legs. Analysed using goniometer
Timepoint [1] 315104 0
3 and 6 weeks post intervention
Secondary outcome [2] 315105 0
Straight leg raise (SLR)
Difference in degrees of leg extension between injured and uninjured legs. Analysed using goniometer
Timepoint [2] 315105 0
3 and 6 weeks post intervention
Secondary outcome [3] 315268 0
Isometric resistance hamstring contraction at 30 degrees and 90 degrees of knee flexion.
Difference in isometric power maintained for 3 seconds between injured and uninjured legs. Analysed using hamstring EFD strength test equipment
Timepoint [3] 315268 0
3 and 6 weeks post intervention

Eligibility
Key inclusion criteria
Recreational athletes with acute hamstring injury occurring during explosive activity, within 96 hours of presentation.
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment will be randomised by random group generation (using random number generation). Treatment will be prepared according to this allocation by a nurse who is not a researcher using opaque syringes to blind the medical doctor as to the treatment group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Other reasons/comments
Other reasons
Supply of the investigated product in Australia was being halted
Date of first participant enrolment
Anticipated
31/07/2015
Actual
8/09/2015
Date of last participant enrolment
Anticipated
Actual
8/09/2015
Date of last data collection
Anticipated
Actual
8/09/2015
Sample size
Target
60
Accrual to date
Final
1
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 291403 0
Government body
Name [1] 291403 0
Australian Institute of Sport High Performance Sports Research Fund
Country [1] 291403 0
Australia
Primary sponsor type
Government body
Name
Australian Institute of Sport
Address
Leverrier St
BRUCE ACT 2617
Country
Australia
Secondary sponsor category [1] 290078 0
None
Name [1] 290078 0
Address [1] 290078 0
Country [1] 290078 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292951 0
Australian Institute of Sport Human Research Ethics Committee
Ethics committee address [1] 292951 0
Leverrier St
BRUCE ACT 2617
Ethics committee country [1] 292951 0
Australia
Date submitted for ethics approval [1] 292951 0
Approval date [1] 292951 0
18/02/2015
Ethics approval number [1] 292951 0
EC00299

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57790 0
Dr David Hughes
Address 57790 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 57790 0
Australia
Phone 57790 0
+61262141578
Fax 57790 0
Email 57790 0
[email protected]
Contact person for public queries
Name 57791 0
Dr Samantha Pomroy
Address 57791 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 57791 0
Australia
Phone 57791 0
+61262141578
Fax 57791 0
Email 57791 0
[email protected]
Contact person for scientific queries
Name 57792 0
Dr Samantha Pomroy
Address 57792 0
Australian Institute of Sport
Leverrier St
BRUCE ACT 2617
Country 57792 0
Australia
Phone 57792 0
+61262141578
Fax 57792 0
Email 57792 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.