Interventional procedure consultation document

Autologous blood injection for tendinopathy

Treating tendon problems by injecting patients with their own blood

Tendons are bands of fibrous connective tissue that connect muscle to bone. ‘Tendinopathy’ describes a range of conditions that affect tendons, usually caused by overuse. The most common tendons affected are in the elbow, the heel and the knee. Symptoms include pain, weakness and stiffness. In autologous blood injection, blood is taken from the patient and re-injected around the affected tendon. Sometimes the blood is separated into red blood cells and platelets (cell fragments that produce substances called growth factors) before injecting the sample containing mostly platelets. The aim is to supply the tendon with growth factors that start the healing process.

The National Institute for Health and Clinical Excellence (NICE) is examining autologous blood injection for tendinopathy and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE’s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about autologous blood injection for tendinopathy.

This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:

• comments on the provisional recommendations
• the identification of factual inaccuracies
• additional relevant evidence, with bibliographic references where possible.

Note that this document is not NICE’s formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that NICE will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendations in the light of the comments received during consultation.
• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.

For further details, see the Interventional Procedures Programme manual, which is available from the NICE website (www.nice.org.uk/ipprogrammemanual).

Through its guidance NICE is committed to promoting race and disability equality, equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our interventional procedures guidance. In particular, we aim to encourage people and organisations from groups who might not normally comment on our guidance to do so.

In order to help us promote equality through our guidance, we should be grateful if you would consider the following question:

Are there any issues that require special attention in light of NICE’s duties to have due regard to the need to eliminate unlawful discrimination and promote equality and foster good relations between people with a characteristic protected by the equalities legislation and others?

Please note that NICE reserves the right to summarise and edit comments received during consultations or not to publish them at all where in the reasonable opinion of NICE, the comments are voluminous, publication would be unlawful or publication would otherwise be inappropriate.

Closing date for comments: 24 July 2012

Target date for publication of guidance: December 2012

1   Provisional recommendations  

1.1   The evidence on autologous blood injection for tendinopathy raises no major safety concerns. The evidence on efficacy remains inadequate, with few studies available that use  appropriate comparators. Therefore, this procedure should only be used with special arrangements for clinical governance, consent and audit or research.

1.2   Clinicians wishing to undertake autologous blood injection for tendinopathy should take the following actions.

• Inform the clinical governance leads in their Trusts.
• Ensure that patients understand the uncertainty about the procedure’s efficacy (especially in the long term), make them aware of alternative treatments and provide them with clear written information. In addition, use of NICE’s information for patients (‘Understanding NICE guidance’) is recommended (available from www.nice.org.uk/IPGXXXpublicinfo).
• Audit and review clinical outcomes of all patients having autologous blood injection for tendinopathy (see section 3.1).

1.3   NICE encourages further research comparing autologous blood injections (with or without techniques to produce platelet-rich plasma) against established non-surgical methods for managing tendinopathy. Trials should clearly describe patient selection (including the site of tendinopathy, duration of symptoms and any prior treatments). Outcome measures should include specific measures of pain and function, and whether subsequent surgical intervention is needed.

2   The procedure

2.1   Indications and current treatments

2.1.1   ‘Tendinopathy’ describes a range of conditions that affect tendons, causing pain, weakness and stiffness. The symptoms are usually associated with overuse. Sites commonly involved are the lateral epicondyle (elbow), Achilles (heel) and patellar (knee) tendons. Tendinopathy also has other names – for example, tendonosis and tendonitis – and it encapsulates a range of pathologies, including inflammatory, non-inflammatory and degenerative changes.

2.1.2   Tendinopathy usually resolves over a period of several months. Conservative treatments include rest, use of orthotic devices, physiotherapy and analgesic therapy. Local injection of steroids, extracorporeal shockwave therapy, or sometimes surgery to release the tendon from the underlying bone or constricting surrounding tissues, can also be used. A period of rehabilitation is usually needed.

2.2   Outline of the procedure

2.2.1   Autologous blood injection (using whole blood or platelet-rich plasma) is claimed to promote healing through the action of growth factors on the affected tendon.

2.2.2   A variable amount of blood is withdrawn from the patient by standard venesection. Sometimes the blood is centrifuged to produce a platelet-rich sample. About 2–3 ml of whole blood or platelet-rich plasma is injected into the area around the damaged tendon, sometimes with ultrasound guidance. Local anaesthetic is usually used; 'dry  needling' (repeatedly passing a needle through the tendon to disrupt the fibres and induce bleeding) may be performed before injection of the blood. After the procedure, patients are usually advised to avoid strenuous or excessive use of the tendon for a few weeks, after which physiotherapy is started. The procedure may be repeated if needed.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published literature that the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview, available at www.nice.org.uk/guidance/IP/549/overview

2.3   Efficacy

2.3.1   In a randomised controlled trial (RCT) of 150 patients with tennis elbow, 70 were treated by autologous blood injection and 80 were treated by platelet-rich plasma injection. Technical success was defined as an improvement in patient-rated tennis elbow evaluation score of 25 points at final analysis; measured on a scale of 0–100, with a higher score indicating more pain and functional disability. Of those patients followed up at 6 months, technical success was reported in 72% (43/60) of patients treated by autologous blood injection and 66% (46/70) treated by platelet-rich plasma injection (p=0.59).

2.3.2   In an RCT of 100 patients with tennis elbow, 51 were treated by platelet-rich plasma injection and 49 were treated by corticosteroid injection. Successful treatment was defined as a reduction of 25% on the visual analogue scale pain score (measured on a scale of 0–100, with higher score indicating more pain) and no reintervention after 2 years. At 2-year follow-up, successful treatment was achieved in 76% (39/51) of patients treated by platelet-rich plasma injection and 43% (21/49) treated by corticosteroid injection (p<0.0001).

2.3.3   In an RCT of 54 patients with Achilles tendinopathy, 27 were treated by platelet-rich plasma injection and 27 were treated by placebo injection. The mean difference on the Victorian Institute of Sports assessment – Achilles (VISA-A) scale (assessing the severity of Achilles tendinopathy on a scale of 0–100, with lower score indicating higher severity) was not significant (6 points [95% confidence interval (CI) −5 to 16]) at 1-year follow-up (p value not reported).

2.3.4   In the RCT of 100 patients with tennis elbow, 12% (6/51) of patients treated by platelet-rich plasma injection and 29% (14/49) of patients treated by corticosteroid injection needed further intervention within 2–14 months. Of those treated by platelet-rich plasma injection, 6% (3/51) had subsequent corticosteroid injections. Of those treated by corticosteroid injection, 16% (8/49) had subsequent corticosteroid or platelet-rich plasma injections.

2.3.5   In the RCT of 54 patients with Achilles tendinopathy, 57% of the platelet-rich plasma group and 42% of the placebo group returned to their previous level of sporting activity (absolute figures not reported). The adjusted between-group difference for return to sports was 2% (95% CI −25 to 28) at 1-year follow-up. This difference was not significant (p=0.89).

2.3.6   The Specialist Advisers listed key efficacy outcomes as pain relief and improved function.

2.4   Safety

2.4.1   In a case series of 28 patients with tennis elbow, 7% (2/28) of patients needed narcotic analgesia because of pain after autologous blood injection. Most patients in this series reported that the pain was similar to the pain they had experienced after previous steroid injections into the tendon.

2.4.2   Moderate pain and stiffness after the injections, which persisted for a few days, was reported in all patients in a case series of 20 patients with patellar tendinosis. One patient had more severe pain after the injection which took 3 weeks to resolve (no further information reported).

2.4.3   The Specialist Advisers listed anecdotal adverse events to be increased pain, flare of pain, reduced functioning, and damage to surrounding tissues. Theoretical adverse events were considered to be tendon rupture, damage to tendon and infection.

2.5   Other comments

2.5.1   The Committee noted that autologous blood injection for tendinopathy can be performed using either autologous whole blood or platelet-rich plasma. The latter aims to deliver a greater concentration of growth factors. Studies comparing the use of whole blood and platelet-rich plasma did not demonstrate any substantial differences in efficacy. Therefore, the Committee considered it reasonable to evaluate the evidence on injection with either whole blood or platelet-rich plasma   as equivalent treatments in this guidance. 

2.5.2    A number of RCTs have been published since this procedure was evaluated in 2009 (NICE IPG 279). However, the Committee considered that the comparators used in most of the studies were not useful in determining whether autologous blood injection for tendinopathy is efficacious.

2.5.3   The Committee was advised that Achilles tendinopathy may respond differently to treatment compared with tendinopathy at other sites, so it may not be valid to extrapolate the findings of studies using this procedure to different sites.

3   Further information

3.1   This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing an audit tool (which is for use at local discretion), which will be available when the guidance is published.

3.2   This guidance is a review of ‘Autologous blood injection for tendinopathy’ NICE interventional procedure guidance 279 (2009).

3.3   For related NICE guidance see www.nice.org.uk

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

June 2012

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