Interventional procedure consultation document

Autologous blood injection for plantar fasciitis

Treating plantar fasciitis by injecting patients with their own blood

Plantar fasciitis occurs when the connective tissue between the heel and the middle of the foot deteriorates. This usually happens because of overuse or injury, and it causes foot pain. In autologous blood injection, blood is taken from the patient and injected into the area around the affected tissue. Sometimes the blood is separated into red blood cells and platelets (cell fragments that produce substances called growth factors) before injecting the sample containing mainly platelets. The aim is to supply the connective tissue with growth factors that promote the healing process.

The National Institute for Health and Clinical Excellence (NICE) is examining autologous blood injection for plantar fasciitis 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 plantar fasciitis.

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• The Advisory Committee will then prepare draft guidance which will be the basis for NICE’s guidance on the use of the procedure in the NHS in England, Wales, Scotland and Northern Ireland.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: 18 September 2012

Target date for publication of guidance: February 2013

1   Provisional recommendations

1.1   The evidence on autologous blood injection for plantar fasciitis raises no major safety concerns. The evidence on efficacy is inadequate in quantity and quality. 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 plantar fasciitis should take the following actions.

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

1.3  NICE encourages further research comparing autologous blood injection (with or without techniques to produce platelet-rich plasma) against established treatments for managing plantar fasciitis. Trials should clearly describe patient selection, including duration of symptoms and any prior treatments. Outcome measures should include specific measures of pain and function.

2   The procedure

2.1   Indications and current treatments

2.1.1   Plantar fasciitis is characterised by chronic degeneration of the plantar fascia causing pain on the underside of the heel. It is usually caused by overuse, injury or biomechanical abnormalities and may be associated with microtears, inflammation or fibrosis. It is usually a self-limiting condition.

2.1.2   Conservative treatments include rest, analgesic medication, non-steroidal anti-inflammatory drugs (NSAIDs), orthotic devices, physiotherapy, eccentric training and stretching. Local injection of steroids, extracorporeal shockwave therapy and surgery to release the plantar fascia from the bone or to relieve muscular tightness are sometimes used for patients with refractory symptoms.

2.2   Outline of the procedure

2.2.1   Autologous blood injection for plantar fasciitis is claimed to promote healing through the action of growth factors. It can be performed using either autologous whole blood or platelet-rich plasma. The latter aims to deliver a greater concentration of growth factors. 

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 plantar fascia, sometimes with ultrasound guidance. Local anaesthetic is usually used. 'Dry needling' (repeatedly passing a needle through the tissue to disrupt the fibres and induce bleeding) may be performed before injection of the blood. A ‘peppering’ technique is sometimes used to inject the autologous blood; this involves inserting the needle into the fascia, injecting some of the blood, withdrawing without emerging from the skin, slightly redirecting and reinserting. After the procedure, patients are usually advised to avoid high-impact activities for a few weeks, and to follow a programme of stretching exercises. 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/1027/overview

2.3   Efficacy

2.3.1   A randomised controlled trial of 64 patients treated by autologous blood injection or corticosteroid injection reported that mean pain scores decreased from 7.3 and 6.9 at baseline to 3.6 and 2.4 respectively at 6 month follow-up (p<0.0001 for both groups; measured on a visual analogue scale from 0–10, with 0 indicating no pain and 10 the worst imaginable pain). The proportion of patients with no change in score was 10% in both groups (3/30 and 3/31 respectively). The mean tenderness threshold improved from 3.1 kg/cm² at baseline to 6.5 kg/cm² in the autologous blood injection group and from 3.7 kg/cm² to 8.6 kg/cm² in the corticosteroid group at 6 months follow-up (p<0.0001 for both groups).

2.3.2   A randomised controlled trial of 45 patients treated by autologous blood injection, corticosteroid injection or peppering alone reported that mean pain scores reduced from 7.6, 7.3 and 6.4 at baseline to 2.4, 2.6 and 2.0 respectively at 6 months follow-up (p<0.001 for all groups; measured on a visual analogue scale from 0–10). The Rearfoot scores (scale 0–100 with higher scores indicating less pain and better function) improved from 72, 66 and 64 at baseline to 81, 80 and 78 respectively at 6 months follow-up (p=0.025, 0.030 and 0.018 respectively). There were no statistically significant differences between the groups.

2.3.3    A non-randomised comparative trial of 100 patients treated by autologous blood injection, local anaesthetic with peppering, corticosteroid injection or corticosteroid injection with peppering reported an ‘excellent’ or ‘good’ outcome in 60% (15/25), 52% (13/25), 80% (20/25) and 88% (22/25) of patients respectively at 6 month follow-up (measured using a modified Roles and Maudsley scale, which measures pain and limitation of activity). There was a statistically significant difference between corticosteroid injection and autologous blood injection and local anaesthetic with peppering, with more successful outcomes in the corticosteroid groups (p<0.05).

2.3.4   The randomised controlled trial of 45 patients treated by autologous blood injection, corticosteroid injection or peppering alone reported that 67% (10/15), 0/14 and 47% (7/15) of patients respectively needed a third injection.

2.3.5   The Specialist Advisers listed key efficacy outcomes as  reduction in heel pain, reduction in pain induced by pressure on the heel, and improved function.

2.4   Safety

2.4.1   The randomised controlled trial of 64 patients treated by autologous blood injection or corticosteroid injection reported that all patients found the procedure to be painful. After the procedure, pain needing analgesia, ice application or both was reported in 53% (16/30) and 13% (4/31) of patients respectively. The mean duration of symptoms was 7 days in the autologous blood injection group and 5 days in the corticosteroid injection group.

2.4.2   A non-randomised comparative study of 60 patients treated by autologous blood injection or corticosteroid injection and a case series of 25 patients reported that there were no adverse events.

2.4.3   The Specialist Advisers listed theoretical adverse events as  rupture of the plantar fascia, local neurovascular damage, infection, and bruising.

2.5   Other comments

2.5.1   The Committee noted that plantar fasciitis is normally a self-limiting condition  which introduces some uncertainty about the relative effect of interventions in the published studies. The comparators used in most of the studies were not useful in determining whether autologous blood injection for plantar fasciitis is efficacious. In addition, the procedure was often used in combination with other therapies.

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

Bruce Campbell

Chairman, Interventional Procedures Advisory Committee

August 2012

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 It is the responsibility of consultees to accurately cite academic work in order that they can be validated.