Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000824066
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
1/10/2010
Date last updated
22/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effectiveness of Autologous Blood Injections for the treatment of mid portion Achilles tendinopathy- a double blind randomised control trial.
Scientific title
The medium term effectiveness of autologous blood injections as an additional treatment to an eccentric strengthening programme for mid portion Achilles tendinopathy using the Victorian Institute of Sport Assessment- Achilles (VISA-A) scale- a double blind randomised control trial.
Secondary ID [1] 252783 0
Nil
Universal Trial Number (UTN)
U1111-1117-2641
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles Tendinopathy 258285 0
Condition category
Condition code
Musculoskeletal 258480 258480 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous Blood Injection. 3ml of blood will be drawn from either antecubital fossa with sterile no touch technique. No local anasthetic will be used. The blood will then be injected with a sterile no touch technique around the area of maximal Achilles tendon tenderness. It will not be injected directly into the tendon. There will not be dry needling and it will not be done under ultrasound guidance. We would hope that the time between aspiration and reinjection to be under one minute. All participants will have one injection, carried out two times in total, a month apart. All participants will carry out the standard Alfredson's eccentric exercise regime.
Intervention code [1] 257301 0
Treatment: Other
Comparator / control treatment
Sham injection. This group will also have 3ml of blood taken from their antecubital fossa. They will have an injection around the area of maximal Achilles tendon tenderness. The same needling technique (three passes of the needle) will be used. No substance will be injected. All participants will carry out the standard Alfredson's eccentric exercise regime.
Control group
Placebo

Outcomes
Primary outcome [1] 259312 0
VISA-A score
Timepoint [1] 259312 0
A VISA-A score will be done at randomisation (baseline) and again at 1,2,3,& 6 months subsequent to this.
Secondary outcome [1] 265748 0
Likert score to assess overall improvement
Ability to return to tendon loading sport
Timepoint [1] 265748 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria: patients presenting to sports medicine/physiotherapy/ general practice clinics with first presentation of mid portion Achilles tendinopathy of at least 3 months duration
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Bilateral Achilles tendinopathy, significant coagulopathy predisposing to bleeding, previous adjuvant treatment of the Achilles tendinopathy.

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)
Participants will be initially assessed regards their eligibility for the study. If they meet the inclusion/ exclusion criteria and have a diagnosis of Achilles Tendinopathy, they will be randomly allocated to either the treatment or placebo group by way of a computer generated randomisation code. Neither the examining doctor nor patient will know their group allocation. Allocation to either group will be concealed to both the participant and the examiner who determines eligibility for inclusion into the trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was by shuffled and sealed envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment outside Australia
Country [1] 2940 0
New Zealand
State/province [1] 2940 0
Wellington

Funding & Sponsors
Funding source category [1] 257737 0
Self funded/Unfunded
Name [1] 257737 0
Dr Kevin Bell
Country [1] 257737 0
Australia
Primary sponsor type
Individual
Name
Professor Ngaire Kerse
Address
Department of General Practice
Tamaki Campus
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 256951 0
Other
Name [1] 256951 0
Wakefield Sportsmed
Address [1] 256951 0
Rintoul St
Newtown
Wellington
6021
Country [1] 256951 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259791 0
Central Ethics Committee
Ethics committee address [1] 259791 0
PO Box 5013
Wellington
6011
Ethics committee country [1] 259791 0
New Zealand
Date submitted for ethics approval [1] 259791 0
Approval date [1] 259791 0
21/09/2010
Ethics approval number [1] 259791 0

Summary
Brief summary
The primary purpose of the study is to determine whether the addition of an autologous blood injection as an adjuvant therapy provides added benefit on top of the standard Alfredson's eccentric exercise regime alone for those with mid portion Achilles tendinopathy.
Trial website
Trial related presentations / publications
Published in the British Medical Journal on 18/4/13
BMJ2013;346:f2310
Public notes

Contacts
Principal investigator
Name 31713 0
Dr Kevin James Bell
Address 31713 0
Sydney Sports Medicine Centre, 6 Figtree Drive, Sydney Olympic Park, NSW 2127
Country 31713 0
Australia
Phone 31713 0
+61 478588889
Fax 31713 0
+61 2 9764 3443
Email 31713 0
[email protected]
Contact person for public queries
Name 14960 0
Dr Dr Kevin Bell
Address 14960 0
Sydney Sports Medicine Centre, 6 Figtree Drive, Sydney Olympic Park, NSW 2127
Country 14960 0
Australia
Phone 14960 0
+61 2 9764 3131
Fax 14960 0
+61 2 9764 3443
Email 14960 0
[email protected]
Contact person for scientific queries
Name 5888 0
Dr Dr Kevin Bell
Address 5888 0
Sydney Sports Medicine Centre, 6 Figtree Drive, Sydney Olympic Park, NSW 2127
Country 5888 0
Australia
Phone 5888 0
+61 2 9764 3131
Fax 5888 0
+61 2 9764 3443
Email 5888 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
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Documents added automatically
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