Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001020077
Ethics application status
Approved
Date submitted
18/11/2010
Date registered
22/11/2010
Date last updated
9/02/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Autologous Blood Injection for Treatment of Achilles Tendinopathy? A Randomised Controlled Trial
Scientific title
In patients with achilles tendinopathy what is the short-term efficacy of adding autologous blood injection to conservative treatment compared with that of conservative treatment alone?
Secondary ID [1] 253119 0
None
Universal Trial Number (UTN)
U1111-1118-2075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Achilles tendinopathy 258681 0
Condition category
Condition code
Physical Medicine / Rehabilitation 258827 258827 0 0
Other physical medicine / rehabilitation
Musculoskeletal 258833 258833 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Autologous blood injection - injection of 2ml of patients own blood around their injured Achilles tendon - added to standard conservative treatment program.

All patients in the treatment group received an initial injection following enrolment in the study. Depending on the response to the initial injection, a second injection following the 6 week follow-up was performed in almost half of these patients.
Intervention code [1] 257640 0
Treatment: Other
Comparator / control treatment
Standard conservative treatment based on eccentric strengthening program
Control group
Active

Outcomes
Primary outcome [1] 259689 0
Victorian Institute of Sport Assessment for Achilles (VISA-A) score
Timepoint [1] 259689 0
Baseline, 6 weeks and 12 weeks
Secondary outcome [1] 266386 0
the treatment group was asked to rate the degree of discomfort experienced

a) during the injection procedure (no significant discomfort, mild discomfort, moderate discomfort, or severe pain) and

b) over the 48 hours following injection, relative to pre-injection (improved, no change, mild discomfort, moderate discomfort, or severe pain).
Timepoint [1] 266386 0
As above

a) during the injection and

b) on average over the 48 hours following injection compared to before the injection

Eligibility
Key inclusion criteria
Diagnosis of mid achilles tendinopathy (activity-related pain of gradual or semi-acute onset, post-inactivity stiffness, and tenderness, swelling and nodularity localised to the mid-tendon) with duration of symptoms of at least three months.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnostic uncertainty or concurrent presence of insertional pathology,
Anticoagulant therapy,
Systemic disease that may contribute to pathology,
Elite level sportsperson, or
Having received any injection therapy for the tendon within the last three months.

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)
Recruitment through a specialist sports medicine clinic.
If meets inclusion criteria and no exclusion criteria, and agrees to participate then randomized by random number selection to standard treatment plus autologous blood injection (treatment) or standard treatment alone (control).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation plan generator. Available online at http://www.randomization.com [select first generator, use seed 21383, labels: “treatment” and “control”, 2 blocks of 20 subjects each]
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/03/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 3054 0
New Zealand
State/province [1] 3054 0
Wellington

Funding & Sponsors
Funding source category [1] 258095 0
Self funded/Unfunded
Name [1] 258095 0
Jake Pearson
Country [1] 258095 0
New Zealand
Primary sponsor type
Individual
Name
Jake Pearson
Address
Wakefield Sports Med
Level 4 Wakefield Specialist Centre
99 Rintoul St
Newtown
Wellington 6242
Country
New Zealand
Secondary sponsor category [1] 257275 0
Individual
Name [1] 257275 0
Ruth Highet
Address [1] 257275 0
Wakefield Sports Med
Level 4 Wakefield Specialist Centre
99 Rintoul St
Newtown
Wellington 6242
Country [1] 257275 0
New Zealand
Other collaborator category [1] 251661 0
Individual
Name [1] 251661 0
David Rowlands
Address [1] 251661 0
Division of Exercise and Sport Science
Institute of Food, Nutrition and Human Health
Massey University
Block 3, Room 3C18 Reception
Entrance C
Wallace St
Mt Cook
Wellington 6021
Country [1] 251661 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260089 0
Central Regional Ethics Committee
Ethics committee address [1] 260089 0
C/- Ministry of Health
1-3 The Terrace
Level 1
Wellington 6011
Ethics committee country [1] 260089 0
New Zealand
Date submitted for ethics approval [1] 260089 0
22/11/2007
Approval date [1] 260089 0
14/12/2007
Ethics approval number [1] 260089 0
CEN/07/12/083

Summary
Brief summary
Abstract:

Aim: To determine whether autologous blood injections added to standard management was effective in alleviating symptoms of achilles tendinopathy.

Methods: Thirty three patients (18 female, 15 male) aged 50 years (SD 9) with 40 cases of achilles tendinopathy of 11 months (SD 7) duration were enrolled in the study. Participants were randomised to autologous blood injection added to standard treatment (eccentric-loading exercises) or standard treatment alone for 12 weeks. Victorian Institute of Sport Assessment for Achilles (VISA-A) score and ratings of discomfort during and following the injection were measured at baseline, six and 12 weeks. Analytically-derived effect-size thresholds of 5 (small) and moderate (15) were utilised as the reference values for clinical inference.

Results: Improvements in VISA-A of 7.7 units (95%CL: +/-6.7) and 8.7 units (+/-8.8) were observed in the treatment and control groups respectively at six weeks relative to baseline with no clear effect of blood injection. At 12 weeks VISA-A score improved to 18.9 units (+/-7.4) in the treatment group revealing a clinically small blood injection effect of 9.6 units (+/-11.5), relative to a comparatively unchanged condition in control (9.4 units; +/-9.0). Predictors of response to treatment were unremarkable, and a 10% rate of post-injection flare was the only noteworthy side-effect. Most patients described the discomfort experienced during the baseline injection as mild, and while there was greater variability in the change in discomfort over the 48 hours following the injection this was on average mild to moderate discomfort.

Conclusions: There is some evidence for small symptomatic improvements in the short-term with the addition of autologous blood injection to standard treatment for achilles tendinopathy, although confirmatory research is required to eliminate a possible placebo effect.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31932 0
Address 31932 0
Country 31932 0
Phone 31932 0
Fax 31932 0
Email 31932 0
Contact person for public queries
Name 15179 0
Jake Pearson
Address 15179 0
Wakefield Sports Med
Level 4 Wakefield Specialist Centre
99 Rintoul St
Newtown
Wellington 6242
Country 15179 0
New Zealand
Phone 15179 0
+64 4 381 8125
Fax 15179 0
+64 4 381 8126
Email 15179 0
[email protected]
Contact person for scientific queries
Name 6107 0
Jake Pearson
Address 6107 0
Wakefield Sports Med
Level 4 Wakefield Specialist Centre
99 Rintoul St
Newtown
Wellington 6242
Country 6107 0
New Zealand
Phone 6107 0
+64 4 381 8125
Fax 6107 0
+64 4 381 8126
Email 6107 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

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