Download Autologous blood injection for soft tissue injury

Survey
yes no Was this document useful for you?
   Thank you for your participation!

* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project

Document related concepts

Gene therapy of the human retina wikipedia , lookup

Dental emergency wikipedia , lookup

Jehovah's Witnesses and blood transfusions wikipedia , lookup

Transcript
Health Policy Advisory Committee on
Technology
Technology Brief
Autologous blood injection for soft tissue injury
November 2012
© State of Queensland (Queensland Health) 2012
This work is licensed under a Creative Commons Attribution Non-Commercial No Derivatives 2.5
Australia licence. In essence, you are free to copy and communicate the work in its current form for
non-commercial purposes, as long as you attribute the authors and abide by the licence terms. You
may not alter or adapt the work in any way.
To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/2.5/au/.
For further information, contact the HealthPACT Secretariat at:
HealthPACT Secretariat
c/o Clinical Access and Redesign Unit, Health Service and Clinical Innovation Division,
Queensland Health
Lobby 2, Level 2, Citilink Business Centre
153 Campbell Street, Bowen Hills QLD 4006
Postal Address: GPO Box 48, Brisbane Qld 4001
Email: [email protected]
Telephone: +61 7 3131 6969
For permissions beyond the scope of this licence contact: Intellectual Property Officer, Queensland
Health, GPO Box 48, Brisbane Qld 4001, email [email protected], phone (07) 3234 1479.
Electronic copies can be obtained from: http://www.health.qld.gov.au/healthpact
DISCLAIMER: This brief is published with the intention of providing information of interest. It is
based on information available at the time of research and cannot be expected to cover any
developments arising from subsequent improvements to health technologies. This brief is based on
a limited literature search and is not a definitive statement on the safety, effectiveness or costeffectiveness of the health technology covered.
The State of Queensland acting through Queensland Health (“Queensland Health”) does not
guarantee the accuracy, currency or completeness of the information in this brief. Information may
contain or summarise the views of others, and not necessarily reflect the views of Queensland
Health.
This brief is not intended to be used as medical advice and it is not intended to be used to diagnose,
treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute
for a health professional's advice. It must not be relied upon without verification from authoritative
sources. Queensland Health does not accept any liability, including for any injury, loss or damage,
incurred by use of or reliance on the information.
This brief was commissioned by Queensland Health, in its role as the Secretariat of the Health Policy
Advisory Committee on Technology (HealthPACT). The production of this brief was overseen by
HealthPACT. HealthPACT comprises representatives from health departments in all States and
Territories, the Australian and New Zealand governments and MSAC. It is a sub-committee of the
Australian Health Ministers’ Advisory Council (AHMAC), reporting to AHMAC’s Hospital Principal
Committee (HPC). AHMAC supports HealthPACT through funding.
This brief was prepared by Arlene Vogan and Stefanie Gurgacz from the Australian Safety and
Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S).
Technology, company and licensing
Register ID
WP133
Technology name
Autologous blood injection
Patient indication
For patients with soft tissue injury
Description of the technology
The injection of a patient’s own (autologous) blood into a region that is affected by a soft
tissue injury may promote the body’s natural healing process.1 Soft tissue injuries, such as
plantar fasciitis (chronic heel pain), lateral epicondylitis (tennis elbow), patella tendinosis
(jumper’s knee) and other forms of tendinopathy are characterised by poor blood supply
that may contribute to the slow healing process. Platelets in the blood carry platelet-derived
growth factors which, when introduced into an injured region, may stimulate a healing
response through the recruitment of stem cells, increased vascularisation and the
production of collagen.1, 2
The procedure was first reported in 20033 and involves a small amount of blood withdrawn
from the patient that is then usually mixed with a local anaesthetic; approximately 2-3 mL is
re-injected into the area around the affected tissue, and can occur under ultrasound
guidance (see Figure 1).1 The main side effects observed are pain and bruising at the site of
the injection, which may persist for one to two weeks. During this period, patients are
advised to avoid strenuous or excessive use of the injured region prior to beginning a
physiotherapy regime. The procedure may be repeated if required.1
Autologous blood injections are inexpensive and simple to acquire and prepare; application
confers minimal trauma, and there is little risk for immune-mediated rejection.3
Figure 1
3
Aspiration and injection of autologous blood. Blood is withdrawn from an
unaffected area (A), and is re-injected into the affected region (B).
Company or developer
Not applicable.
Autologous blood injection for soft tissue injury: November 2012
1
Reason for assessment
Topic resulting from horizon scanning activities; potential controversy about benefits and
risk of excessive diffusion.
Stage of development in Australia

Yet to emerge

Established

Experimental

Established but changed indication or modification of
technique

Investigational

Should be taken out of use

Nearly established
Licensing, reimbursement and other approval
Autologous blood injections are exempt from Therapeutic Goods Administration (TGA) and
US Food and Drug Administration (FDA) regulation.4
Australian Therapeutic Goods Administration approval

Yes

No

Not applicable
ARTG number (s)
Technology type
Procedure
Technology use
Therapeutic
Patient indication and setting
Disease description and associated mortality and morbidity
Soft tissue refers to the tissue that connects, supports or surrounds the structures and
organs of the body, and among others includes muscles, tendons, ligaments, fascia and
nerves. Soft tissue injuries may occur acutely and present as bruises, sprains or strains, or
can alternatively develop over time as a result of overuse and repetitive friction, pulling,
twisting or compression that leads to the progressive degeneration of the soft tissue.5, 6 The
recovery time for most soft tissue injuries is generally one to six weeks; however, this may
vary depending on the patient’s age and general health, and the severity of the injury.5
Hospital separations data for soft tissue injuries in Australia and New Zealand for 2009-10
are listed in Table 1.7 It is unclear from this data which patients would benefit from therapy
with autologous blood injections. Soft tissue injuries accounted for almost half of the
640,700 Australians who experienced a work-related injury in 2009-10, with 30 per cent
experiencing a sprain or strain, and chronic joint or muscle conditions experienced by
18 per cent.8
Autologous blood injection for soft tissue injury: November 2012
2
Table 1
7
Separation statistics of soft tissue injury, Australia and New Zealand 2009-10
Principal diagnosis in ICD-10-AM classification
S43 Dislocation, sprain and strain of joints and ligaments of
shoulder girdle
S46 Injury of muscle and tendon at shoulder and upper arm level
Australia
New Zealand
5,128
878
3,751
651
S53 Dislocation, sprain and strain of joints and ligaments of elbow
1,025
322
S56 Injury of muscle and tendon at forearm level
2,143
355
S93 Dislocation, sprain and strain of joints and ligaments at ankle
and foot level
S96 Injury of muscle and tendon at ankle and foot level
2,053
743
1,287
269
The recovery time of chronic soft tissue injuries, such as lateral epicondylitis and other
forms of tendinopathy may be between 12 and 18 months. These chronic injuries are
generally considered self-limiting, with management plans restricted to physical therapy,
analgesic medication and the use of anti-inflammatory agents, such as non-steroidal antiinflammatory agents (NSAIDs) and/or corticosteroid injections.9 While drugs provide
symptomatic relief, enabling a patient to manage the injury and associated pain, they do not
accelerate the restoration of tissue function.10
Lateral epicondylitis, more commonly referred to as tennis elbow, is a frequent source of
elbow pain, wrist dysfunction and tenderness. Prevalence is estimated between 1 to
3 per cent, with an estimated incidence of 4 to 7 per 1,000 patients per year. In addition to
sporting activities, such as tennis or golf, lateral epicondylitis may be more common in
strenuous jobs, with prevalence reported up to 14.5 per cent.6
Plantar fasciitis is characterised by the chronic degeneration of the plantar fascia that causes
pain on the underside of the heel, typically caused by overuse, injury or biomechanical
abnormalities.11 The estimated prevalence in the general population is 3.6-7 per cent,12
while the prevalence of heel pain reported in one population-based Australian study was
3.6 per cent.13 Plantar fasciitis has been reported to account for approximately
eight per cent of all running-related injuries.12
Furthermore, muscular injuries account for approximately 35-45 per cent of all sportrelated injuries and may prevent participation in athletic training and competition;
consequently, there may be great benefits for professional athletes in particular to use a
therapy that may facilitate a more rapid recovery.
Number of patients
No evidence was identified to indicate the potential number of patients per 100,000
population who would benefit from autologous blood injection.
Autologous blood injection for soft tissue injury: November 2012
3
Speciality
Orthopaedics, rheumatology and podiatry
Technology setting
Specialist hospital, ambulatory care
Impact
Alternative and/or complementary technology
Autologous blood injections are likely to be used in addition to, or in substitution of, current
treatment options for soft tissue injury.
Current technology
Conservative treatments for persistent soft tissue injuries include rest, compression,
analgesic medication, NSAIDs, physiotherapy, eccentric training and stretching.
Corticosteroid injections are common practice for persistent pain or pain that interferes
with rehabilitation or daily activities. Soft tissue injuries that are characterised by
degeneration from overuse (including lateral epicondylitis and other forms of tendinopathy)
typically display no evidence of inflammation, and treatment with anti-inflammatories,
NSAIDs in particular, may be ineffective and potentially harmful, due to the gastrointestinal
side effects associated with long term use.9
Corticosteroid medications inhibit the accumulation of the cells of the immune system that
produce inflammatory mediators. Depending on the location of the injury, evidence
suggests these injections are effective in producing symptom relief in the short term (6-8
weeks); however, long-term effectiveness is uncertain.
Diffusion of technology in Australia
Autologous blood injection therapy is diffuse in Australia and is predominantly made
available through the private sector, and in particular through specialised sport and
radiology clinics.14 There is indication that the therapy is practised in some of the
professional football leagues of Australia.15
International utilisation
Country
Level of Use
Trials underway or
completed
Australia
a
Limited use
a
Widely diffused

New Zealand


United States


United Kingdom


India

Iran

Malaysia

Autologous blood injection is particularly diffuse within the field of sports medicine in Australia
Autologous blood injection for soft tissue injury: November 2012
4
Cost infrastructure and economic consequences
Autologous blood injection therapy itself is relatively inexpensive; many Australian clinics
that currently provide this service do so under ultrasound guidance, which would contribute
an additional cost for both the use of the machine and the time of a sonographer or
radiologist.
Ethical, cultural or religious considerations
Autologous blood injections were previously embargoed by the World Anti-Doping Agency
due to concerns regarding use for blood doping; the relaxation of this embargo enables use
of the therapy in the treatment of most injuries in elite athletes, provided a declaration of
use is provided. Muscle injuries, however, may require a therapeutic use exemption for
autologous blood injections.16
Evidence and Policy
Safety and effectiveness
Three randomised controlled trials (level II intervention evidence) have been included that
assess the safety and effectiveness of autologous blood injection compared to injection with
a corticosteroid,17, 18 or corticosteroid and placebo19 in patients with lateral epicondylitis.
Autologous blood injections have additionally been trialled in indications of chronic plantar
fasciitis and patellar tendinosis; the results of a study for each indication has additionally
been summarised.20, 21
Dojode17
A randomised controlled trial (level II intervention evidence) was conducted at a singlecentre in India by Dojode. Patients (n=60) were recruited upon diagnosis of lateral
epicondylitis after presentation to an outpatient department, and included patients who
were older than 15 years. Patients were excluded if they had received steroid injections in
the three months prior, previous surgeries for lateral epicondylitis or the presence of other
causes of elbow pain. Patients were allocated sequentially into Groups A or B according to a
computer-generated randomisation table. The method of blinding, if performed, was not
reported. Group A (n=30) was designated to receive an injection of autologous blood (2 mL)
drawn from the upper limb vein mixed with 1 mL of a local anaesthetic (0.5% bupivacaine);
Group B (n=30) was designated to receive an injection volume of 2 mL, consisting of 80 mg
methylprednisolone acetate corticosteroid mixed with 1 mL of a local anaesthetic (0.5%
bupivacaine). At baseline, no significant differences were reported for age, mean duration
of symptoms, type of employment (manual or non-manual) or whether the injury was on
the dominant arm. Injection into the lateral epicondyle was guided by anatomical
landmarks, with patients advised to rest the upper limb for three days after injection. Losses
Autologous blood injection for soft tissue injury: November 2012
5
to follow up were not reported. The level of pain was the outcome of interest, and was
assessed prior to injection, and at 1-, 4-, 12-week and 6-month follow-up using:
visual analogue scale (VAS), where the patient was asked to indicate pain levels on a
scale from 0 (no pain) to 10 (worst pain ever); and
the Nirschl staging system, which consists of seven phases in ascending order of pain
(Table 2).
Table 2
Nirschl staging system
Phase
1
2
3
4
5
6
7
17
Description
Mild pain with exercise, resolves within 24 hours
Pain after exercise, exceeds 48 hours
Pain with exercise, does not alter activity
Pain with exercise, alters activity
Pain with heavy activities of daily living
Pain with light activities of daily living, intermittent pain at rest
Constant pain at rest, disrupts sleep
Safety
Of the patients who received an autologous blood injection, significantly more, 18/30 (60%),
complained of an increase in pain immediately and in the days following the injection,
compared to 8/30 (26%) who received an injection with the corticosteroid (p=0.009). While
two (7%) patients who received an injection with corticosteroid developed local skin
atrophy, no instances were observed in those who were injected with autologous blood;
however, this difference was not significant (p>0.05, chi-squared test). There were no
instances in either group of elbow stiffness, infection, neurovascular damage, tendon
rupture or other complications.
Effectiveness
Prior to injection, no significant differences were observed between groups for mean VAS
and Nirschl staging systems scores (Table 3, Figure 2). At one week and four weeks after the
injection, both groups displayed lower levels of pain; however, the group that received the
corticosteroid injection reported significantly lower scores than the groups that received
autologous blood. After four weeks, however, the pain levels in the corticosteroid group
steadied, and began to rise, with significantly lower pain levels observed in the autologous
blood group at the 12-week and six-month follow-up.
At six-month follow-up, significantly more patients (27/30) who received autologous blood
injections were completely relieved of pain, compared to 14 of 30 who received injections
with corticosteroid (p<0.001, chi-squared test). The rate of lateral epicondylitis recurrence
at six months was significantly higher in the corticosteroid group (37%), compared to no
recurrences observed in the autologous blood group (p<0.001, chi-squared test).
Autologous blood injection for soft tissue injury: November 2012
6
Table 3
Mean pain scores measured by VAS and Nirschl stage during follow-up period.
Follow up
Pre-injection
Visual Analogue Scale (VAS) score
Group A
Group B
p-value
7.7 (1.3)
7.5 (1.3)
0.5395
Nirschl stage score
Group A
Group B
5.4 (1.1)
5.2 (1.0)
p-value
0.4918
1 week
7.2 (1.9)
4.5 (1.9)
<0.0001
5.1 (1.5)
3.1 (1.4)
<0.0001
4 weeks
3.2 (2.4)
1.5 (2.3)
0.0022
2.2 (1.6)
1.0 (1.6)
0.003
12 weeks
0.6 (1.9)
1.5 (1.8)
0.0127
0.43 (1.3)
1.0 (1.3)
0.0184
6 months
0.5 (1.9)
1.8 (2.0)
0.0058
0.36 (1.3)
1.2 (1.4)
0.0064
17
Group A received autologous blood injection; Group B received corticosteroid injection. All data is reported as a mean
(standard deviation).
* indicates significant differences (p<0.05)
Figure 2
Course of mean VAS (A) and Nirschl stage (B) scores during follow-up period.
17
Kazemi et al18
A single-blinded randomised controlled trial (level II intervention evidence) was conducted
at a single-centre outpatient department in Iran by Kazemi and colleagues. Consecutive
patients (n=60) with a new episode of lateral epicondylitis within the previous year were
recruited after referral by physical medicine and rehabilitation specialists. Patients were
excluded if they had active or a history of arthritis, previous operations on the elbow or
corticosteroid injections in the three months prior. Patients were randomised by sequential
allocation, with the first patient randomly assigned by coin toss; outcome assessors were
blinded to the treatment allocation. The Autologous Blood (AB) group was designated
treatment with 2 mL autologous blood drawn from the ipsilateral upper limb and mixed
with 1 mL local anaesthetic (2% lidocaine), while the Local Corticosteroid (LC) group
received a single dose of local corticosteroid (single dose injection of 20 mg
methylprednisolone) mixed with 1 mL local anaesthetic (2% lidocaine). No significant
differences were observed between groups for baseline characteristics of age, duration of
symptoms or injury to dominant arm. Injection into the lateral epicondyle was guided by
anatomical landmarks, with patients advised to avoid pain-provoking stresses to the elbow
region particularly within the first 48 hours after injection. For the duration of the study,
patients were instructed not to use a brace, physiotherapy or analgesic medications. All
Autologous blood injection for soft tissue injury: November 2012
7
patients recruited completed the trial. The subjective severity of pain within the last 24
hours, as measured by VAS, was the primary outcome measure, with secondary outcome
measures including:
disabilities of the arm, shoulder and hand quick questionnaire (quick DASH), which
includes 11 rating scale questions from 1 (no difficulty) to 5 (unable) to assess
improvement in functional status
modified Nirschl scores, a five point scale ranging from 0 (no pain with exercise) to 4
(severe pain with normal activities of daily living)
dynamometer, to measure muscle strength
algometer, to measure pain thresholds.
Safety
There were no noticeable or reported side effects of the treatment observed in either
group.
Effectiveness
Prior to injection, no significant differences were observed between groups for all outcome
measures. Outcome measures at four weeks had improved significantly within each group
compared to baseline, except for pain thresholds in the group treated with the
corticosteroid. Between four and eight weeks, all outcomes continued to significantly
improve in the autologous blood group, with only significant improvements in the
corticosteroid group observed for limb pain and maximum grip strength.
When groups were compared, at four weeks all outcomes except limb function, grip
strength and the modified Nirschl score showed significant improvements for the
autologous blood group (Table 4). At eight weeks, all outcomes were significantly in favour
of the autologous blood group.
Table 4
Comparison of outcomes at 4 and 8 weeks after treatment
Four weeks after injection
AB
LC
p-value
2.7 (0.9)
4.5 (2.5)
0.001
Eight weeks after injection
AB
LC
p-value
1.5 (1.2)
4 (2.6)
<0.001
3 (1.2)
3.4 (2)
0.351
1.5 (1.3)
3.4 (2.2)
<0.001
Pain in maximum grip
3 (1)
4.7 (2.6)
0.002
1.4 (1.4)
4.2 (2.5)
<0.001
Pressure pain threshold
(algometer)
Maximum grip strength
(dynamometer)
Modified Nirschl
14.4 (7.1)
10.6 (6.2)
0.031
20.7 (10.6)
10.8 (5.7)
<0.001
41.2 (19.3)
33.2 (14)
0.072
47.8 (15)
31.1 (15.7)
<0.001
1.5 (0.7)
1.9 (1)
0.090
0.7 (0.7)
1.8 (1.1)
<0.001
Quick DASH
21 (10.6)
32.3 (17.2)
0.004
6.9 (12.6)
32.4 (19.4)
<0.001
Limb pain at rest within
last 24 hours
Limb function within last
24 hours
AB: autologous blood; LC: local corticosteroid. Data reported as mean (standard error).
Autologous blood injection for soft tissue injury: November 2012
8
Wolf et al19
A blinded randomised controlled trial (level II intervention evidence) was conducted in two
centres in the United States by Wolf and colleagues. Patients (n=34) who had not been
treated with an injection for lateral epicondylitis in the previous six months were included in
the study; those with a history of elbow surgery, inflammatory arthritis or autoimmune
diseases were excluded. Patients were randomised into three treatment groups by sealed
envelopes generated centrally by a random numbers table. The three groups received 2 mL
of either autologous blood, corticosteroid or saline mixed with 1 mL of lidocaine (total
volume 3 mL); the concentrations of the corticosteroid or local anaesthesia were not
reported. The syringe that contained the injection was covered with aluminium foil so as to
blind the patient to treatment; outcome assessors were not blinded. Baseline characteristics
of the treatment groups were not reported. Injection into the lateral epicondyle was guided
by anatomical landmarks, after which each patient was given a standard sheet of stretching
exercises and was not provided with other forms of therapy or splints for the six-month
duration of the study. Six patients did not complete the study, three subjects dropped out
after two weeks and three were lost to follow up after the initial injection. Data was
analysed for 28 patients, of which n=9 had been randomised to be treated with saline, n=10
to autologous blood and n=9 received steroid injections. One patient in each group
requested an additional injection at two months. It is unclear what they received; and
patients were not blinded to the repeat injection. The primary outcome measure was the
DASH outcomes score, with pain- and disease-specific functional scores, as measured by the
VAS and the Patient Rated Forearm Evaluation (PRFE) questionnaires respectively, as the
secondary measures. The latter measure, the PRFE, was subdivided into pain and functional
scales, with each analysed separately.
Safety
Adverse events and other safety outcomes were not reported in the study.
Effectiveness
Patients were asked to complete the DASH, VAS and PRFE questionnaires pre-injection and
at two weeks, and two and six months after injection. Compared to baseline, each of the
treatment groups observed significant improvements in the DASH scores at six months
(p<0.001); however, these differences were not significant for other time points. No
significant differences were observed in the DASH scores between the treatment groups
(p>0.05).
Similarly, improvements were observed in each of the treatment groups for the secondary
measures, with no significant differences between the groups for the improvement in the
PRFE pain scores and the VAS score. The saline-treated group showed the most
improvement as assessed by the PRFE function score and was significantly better than the
Autologous blood injection for soft tissue injury: November 2012
9
group treated with autologous blood (p=0.048). Differences between the steroid-treated
group and the saline-treated or autologous blood-treated groups were not significant.
Summary of studies for alternative indications
A prospective, randomised controlled trial (level II intervention evidence) was conducted by
Lee and colleagues21 that compared injections of autologous blood to corticosteroid in the
treatment of chronic plantar fasciitis; 61 patients were enrolled. Similar to the studies
reported for lateral epicondylitis, both treatment groups observed significant reduction in
pain levels (p<0.001); however, no significant difference were observed between the
treatment groups at six months. Pain relief was more rapid in the group treated with
corticosteroid injection. No adverse events such as fat pad atrophy, infections or rupture of
the plantar fascia were observed; however, all patients indicated the injection was painful,
with post-injection pain that required analgesia and/or ice application in 16/30 (53%) of
patients treated with autologous blood, and 4/31 (13%) treated with corticosteroid.
A case-series study (level IV interventional evidence) was conducted by James et al20 in the
UK that treated patients with patellar tendinosis (jumper’s knee) with autologous blood
injection. Consecutive patients (n=44, with n=47 treated knees) were enrolled, with the
injection of autologous blood administered via ultrasound guidance and dry needling, which
involved the repeated passing of the needle through the abnormal tendon for a one minute
period. At post-procedure follow up, subjective knee functionality scores significantly
improved (p<0.001). In a sub-set of 21 patients (with 24 treated knees), follow-up
ultrasound examination observed a reduction in tendon thickness in 22/24 cases; however,
only one case could be classed as normal. Safety outcomes were not reported.
Economic evaluation
No economic evaluations were identified in the preparation of this report.
Ongoing research
One newly registered trial (ClinicalTrials.gov Identifier: NCT01668953) has been identified
which compares autologous blood injection to a placebo, dry needling and platelet-rich
plasma injection in the treatment of lateral epicondylitis.22 The study aims to enrol 60
patients, with study completion in 2014.
Other issues
Four of the studies included did not perform autologous blood injection under ultrasound
guidance, a method which is often practised in Australia.
As the proposed mechanism of action of autologous blood injection is mediated by the
platelet derived growth factors, higher concentrations of platelets injected may be more
beneficial, with the development of platelet-rich plasma injections. The systems used to
Autologous blood injection for soft tissue injury: November 2012
10
isolate the platelets from autologous blood have TGA (ARTG numbers include 100053,
133209)23, FDA and CE mark approval, with ongoing and completed trials conducted in
Australia (ClinicalTrials.gov Identifier: NCT01414764)24 and in other sites around the world.
Clinical advice suggests that platelet-rich plasma injections may supersede injections with
autologous blood, with diffusion of the technology observed in Australia.25 The incremental
benefits of the procedure compared to autologous blood injection are uncertain; at least
one large double-blind randomised controlled trial for lateral epicondylitis observed little
difference between treatment groups for outcomes assessed.16
Summary of findings
Two of the three included randomised controlled trials reported safety outcomes for the
treatment of autologous blood injections in patients with lateral epicondylitis; while one
observed no side effects of the treatment, the other reported significantly more pain after
autologous blood injection compared to corticosteroid. In this same study, two patients
treated with corticosteroid reported skin atrophy, with no reports in patients who received
autologous blood. No instances of tendon rupture were reported. Other safety concerns
associated with the treatment may include bruising and infection; the studies included did
not report on these outcomes.
In terms of effectiveness, each of the studies included for the lateral epicondylitis indication
reported significantly improved outcomes compared to baseline regardless of the treatment
group (autologous blood, corticosteroid) and patients receiving placebo (saline) also
reported improvements compared to baseline. The two studies that compared injections of
autologous blood to corticosteroid observed significantly better improvement in patients
who were treated with blood, particularly at time points beyond one month. No significant
differences were observed between the treatment groups in the study that compared
autologous blood to steroid or saline injections.
The evidence for autologous blood injection in other indications such as chronic plantar
fasciitis and patellar tendinosis each showed an improvement in symptoms. When
compared to corticosteroid injections, however, no significant differences were observed
for the indication of chronic plantar fasciitis. Additionally, no conclusions can be drawn
regarding the comparative effectiveness of autologous blood injections in patellar
tendinosis as no comparative evidence was available.
The comparator chosen in the studies included, corticosteroid injections, may be
inappropriate, as other options, including rest, NSAIDs and physiotherapy, may better
reflect current practice. Consequently, conclusions regarding the comparative effectiveness
of autologous blood injections to these more conventional and accepted treatments cannot
be drawn.
Autologous blood injection for soft tissue injury: November 2012
11
HealthPACT assessment
Based on the level and availability of evidence for multiple indications, in addition to the
diffusion of autologous blood injections within Australia, the HealthPACT agreed the
technology should be monitored for 24 months, or until the availability of pending RCT trial
results.
Number of studies included
All evidence included for assessment in this Technology Brief has been assessed according
to the revised NHMRC levels of evidence. A document summarising these levels may be
accessed via the HealthPACT web site.
Total number of studies 5
Total number of Level II studies 4
Total number of Level IV studies 1
References
1.
National Institute for Health and Clinical Excellence (2012). Interventional procedure
overview of autologous blood injection for tendinopathy, UK. Report No.: IP549
http://www.nice.org.uk/nicemedia/live/11979/41368/41368.pdf.
2.
Annett, P. (2012). Autologous Blood Injections in the Management of Tendinopathy.
Available from:
http://www.orthosports.com.au/SiteMedia/w3svc994/Uploads/Documents/2012%2
0Newsletter%20-%20Winter%20(1MB)-1.pdf [Accessed 20 Sep 2012].
3.
Edwards, S. G.&Calandruccio, J. H. (2003). 'Autologous blood injections for refractory
lateral epicondylitis'. J Hand Surg Am, 28 (2), 272-8.
4.
Therapeutic Goods Administration (2008). Regulation of blood. Available from:
http://www.tga.gov.au/industry/bt-blood.htm [Accessed 19 Sep 2012].
5.
Sports Medicine Australia (2012). Soft tissue injuries A guide to prevention and
management. Available from: http://sma.org.au/wp-content/uploads/2011/01/719SMA-InjuryBrochure-softtissue_web.pdf [Accessed 18 Sep 2012].
6.
Krogh, T. P., Bartels, E. M. et al (2012). 'Comparative Effectiveness of Injection
Therapies in Lateral Epicondylitis: A Systematic Review and Network Meta-analysis
of Randomized Controlled Trials'. Am J Sports Med.
7.
Australian Institute of Health and Welfare [AIHW] (2011). Hospitals Data - Separation
statistics by principal diagnosis in ICD-10-AM, Australia, 2008-09 to 2009-10.
Available from: http://www.aihw.gov.au/hospitals-data-cube/?id=10737419429
[Accessed 19 Sep 2012].
8.
Australian Bureau of Statistics (2010). 6324.0 - Work-Related Injuries, Australia,
2009-10 Available from:
http://www.abs.gov.au/ausstats/[email protected]/Latestproducts/6324.0Main%20Features
32009-10?opendocument&tabname=Summary&prodno=6324.0&issue=200910&num=&view [Accessed 19 Sep 2012].
Autologous blood injection for soft tissue injury: November 2012
12
9.
Paoloni, J. A.&Orchard, J. W. (2005). 'The use of therapeutic medications for softtissue injuries in sports medicine'. Med J Aust, 183 (7), 384-8.
10.
Andia, I., Sanchez, M.&Maffulli, N. (2011). 'Platelet rich plasma therapies for sports
muscle injuries: any evidence behind clinical practice?'. Expert Opin Biol Ther, 11 (4),
509-18.
11.
National Institute for Health and Clinical Excellence (2012). Interventional procedure
overview of autologous blood injection for plantar fasciitis, UK. Report No.: IP1027
http://www.nice.org.uk/nicemedia/live/13883/60672/60672.pdf.
12.
McMillan, A. M., Landorf, K. B. et al (2012). 'Ultrasound guided corticosteroid
injection for plantar fasciitis: randomised controlled trial'. BMJ, 344, e3260.
13.
Hill, C. L., Gill, T. K. et al (2008). 'Prevalence and correlates of foot pain in a
population-based study: the North West Adelaide health study'. J Foot Ankle Res, 1
(1), 2.
14.
Personal Communication (HealthPACT Committtee). 9 Nov 2012.
15.
Tucker, J. (2011). Kurtley Beale undergoes blood injection therapy in bid to be ready
for Rugby World Cup semi-final against New Zealand [Internet]. The Daily Telegraph.
Available from: http://www.heraldsun.com.au/sport/rugby-gold/kurtley-bealeundergoes-blood-injection-therapy-in-bid-to-be-ready-for-rugby-world-cup-semifinal-against-new-zealand/story-fn8ouw0e-1226166256761 [Accessed 19 Sep 2012].
16.
Creaney, L., Wallace, A. et al (2011). 'Growth factor-based therapies provide
additional benefit beyond physical therapy in resistant elbow tendinopathy: a
prospective, double-blind, randomised trial of autologous blood injections versus
platelet-rich plasma injections'. Br J Sports Med, 45 (12), 966-71.
17.
Dojode, C. M. (2012). 'A randomised control trial to evaluate the efficacy of
autologous blood injection versus local corticosteroid injection for treatment of
lateral epicondylitis'. Bone and Joint Research, 1 (8), 192-7.
18.
Kazemi, M., Azma, K. et al (2010). 'Autologous blood versus corticosteroid local
injection in the short-term treatment of lateral elbow tendinopathy: a randomized
clinical trial of efficacy'. Am J Phys Med Rehabil, 89 (8), 660-7.
19.
Wolf, J. M., Ozer, K. et al (2011). 'Comparison of autologous blood, corticosteroid,
and saline injection in the treatment of lateral epicondylitis: a prospective,
randomized, controlled multicenter study'. J Hand Surg Am, 36 (8), 1269-72.
20.
James, S. L., Ali, K. et al (2007). 'Ultrasound guided dry needling and autologous
blood injection for patellar tendinosis'. Br J Sports Med, 41 (8), 518-21; discussion 22.
21.
Lee, T. G.&Ahmad, T. S. (2007). 'Intralesional autologous blood injection compared
to corticosteroid injection for treatment of chronic plantar fasciitis. A prospective,
randomized, controlled trial'. Foot Ankle Int, 28 (9), 984-90.
22.
ClinicalTrials.gov (2012). Comparison of Platelet Rich Plasma and Alternative
Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE).
Available from: http://www.clinicaltrials.gov/ct2/show/NCT01668953 [Accessed 24
Sep 2012].
23.
Therapeutic Goods Administration (2012). Australian Register of Therapeutic Goods
(ARTG). Available from: https://www.ebs.tga.gov.au/ [Accessed 24 Sep 2012].
Autologous blood injection for soft tissue injury: November 2012
13
24.
ClinicalTrials.gov (2011). Does Autologous Conditioned Plasma Enhance Rotator Cuff
Tendon Healing After Surgery? Available from:
http://www.clinicaltrials.gov/ct2/show/NCT01414764 [Accessed 24 Sep 2012].
25.
Personal Communication. 5 Oct 2012.
Search criteria to be used (MeSH terms)
Autologous blood injection, blood [MeSH Terms], tendinosis, tendinopathy[MeSH Terms],
lateral epicondylitis, tennis elbow[MeSH Terms], plantar fasciitis
Autologous blood injection for soft tissue injury: November 2012
14