Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000533392
Ethics application status
Approved
Date submitted
8/09/2008
Date registered
20/10/2008
Date last updated
20/10/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of manual therapy for the prevention of hamstring injuries in Australian Rules footballers
Scientific title
A randomised controlled trial of manual therapy for the prevention of hamstring injuries in Australian Rules footballers
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hamstring injuries 3651 0
Condition category
Condition code
Musculoskeletal 3819 3819 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A manual therapy approach consisting of high-velocity low-amplitude (HVLA) manipulation (either manual or mechanically assisted techniques), mobilization and/or supporting soft tissue therapies: various stretching and soft tissue massage techniques to the spine, pelvis and extremity. The intervention was administered to players during the week and not on match days. There was no set time frame for the duration of each manual therapy session, with each being patient specific in duration. Treatment scheduling was also pragmatically determined. The minimum scheduling adhered to was: 1 treatment per week for 6 weeks followed by 1 treatment per fortnight for 3 months and 1 treatment per month for the remainder of the season (3 months). Both the intervention and control group continued to receive the standard club medical, paramedical and sports science management including medication, manipulative physiotherapy, massage, strength and conditioning and rehabilitation as directed by club staff, which acted as the control.
Intervention code [1] 3367 0
Prevention
Comparator / control treatment
Both the intervention and control group continued to receive the standard club medical, paramedical and sports science management including medication, manipulative physiotherapy, massage, strength and conditioning and rehabilitation as directed by club staff, which acted as the control. This was administered for the duration of the 2005 football season commencing 6 weeks prior to round 1. This ran from January to and including September.
Control group
Active

Outcomes
Primary outcome [1] 4716 0
Prevention of hamstring injuries. The injury definition was a "any physical or medical condition that prevents a player from participating in a regular season (home and away) or finals match". The injury surveillance was conducted weekly. Injury diagnoses were determined by club medical staff who were blinded to group allocation using either clinical features of injury, advanced imaging or both at their discretion with blinded club recorders completing the injury surveillance.
Timepoint [1] 4716 0
A weekly injury surveillance conducted for the duration of the home and away season and finals series (approximately 6 month duration).
Secondary outcome [1] 7964 0
Prevention of non-contact knee injuries and lower limb muscle strains. The injury definition was a "any physical or medical condition that prevents a player from participating in a regular season (home and away) or finals match". The injury surveillance was conducted weekly. Injury diagnoses were determined by club medical staff who were blinded to group allocation using either clinical features of injury, advanced imaging or both at their discretion with blinded club recorders completing the injury surveillance.
Timepoint [1] 7964 0
A weekly injury surveillance conducted for the duration of the home and away season and finals series (approximately 6 month duration).

Eligibility
Key inclusion criteria
Players were eligible to participate if they were listed players on their respective Victorian Football League (VFL) squad
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
"Red flag" conditions including: fractures, infections, inflammatory diseases, tumours and other causes of destructive lesions of the spine.
"Yellow flag" conditions including: insurance claims, litigation; history of malignant disease.
Clinical signs suggesting inguinal or femoral hernia.
Vascular disease.
History of motor vehicle accident, or other serious fall or accident in the last three months.
Neurological signs and symptoms (muscle wasting, nerve root signs, bowel, bladder or sexual dysfunction).
Organic kidney, urinary tract or reproductive disease.
Previous recent spinal surgery (less than 2 years).
Club doctor or medical staff excludes the players participation.
Players with a severe history of chronic hamstring problems.
Players with serious injury or who undergo surgery preventing play for the remainder of the season.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Players completed a self-reported questionnaire at their training location prior to randomisation. The questionnaire consisted of the validated and reliable McGill Pain Questionnaire (short form) (MPQ-SF) for low back pain (LBP), the 39 item Health Status Questionnaire (SF-39) as well as self reported questions on knee and hamstring injury history (incidence during the previous month, 6 months, year, 2 years, greater than 2 years, not at all). At each of the two clubs after completion of the baseline questionnaire, players were randomly allocated into one of two groups such that allocation was concealed using central randomisation by computer. Eligible players were stratified by age and hamstring injury history within these strata as these are the most recognized predictors for injury. Randomization was completed within each club to prevent an element of randomness in a clubs injury profile each season impacting on the results of the study. After all subjects at the 2 clubs had been allocated the two groups at both clubs club were then randomly allocated to either the intervention or control with a coin toss.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization list
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3832 0
Self funded/Unfunded
Name [1] 3832 0
Wayne Hoskins
Country [1] 3832 0
Australia
Funding source category [2] 3969 0
Self funded/Unfunded
Name [2] 3969 0
Country [2] 3969 0
Primary sponsor type
Individual
Name
Wayne Hoskins
Address
203/459 Royal Parade Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 3441 0
None
Name [1] 3441 0
Address [1] 3441 0
Country [1] 3441 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5884 0
Macquarie University Human Ethics Committee
Ethics committee address [1] 5884 0
Ethics committee country [1] 5884 0
Australia
Date submitted for ethics approval [1] 5884 0
Approval date [1] 5884 0
Ethics approval number [1] 5884 0
Ethics Approval Number: HE27AUG2004-RO3066

Summary
Brief summary
Objective: To investigate whether a manual therapy intervention can prevent the occurrence of hamstring and lower-limb injuries.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28906 0
Address 28906 0
Country 28906 0
Phone 28906 0
Fax 28906 0
Email 28906 0
Contact person for public queries
Name 12063 0
Wayne Hoskins
Address 12063 0
203/459 Royal Parade Parkville VIC 3052
Country 12063 0
Australia
Phone 12063 0
0425253907
Fax 12063 0
Email 12063 0
[email protected]
Contact person for scientific queries
Name 2991 0
Wayne Hoskins
Address 2991 0
203/459 Royal Parade Parkville VIC 3052
Country 2991 0
Australia
Phone 2991 0
0425253907
Fax 2991 0
Email 2991 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.