Condition category
Musculoskeletal Diseases
Date applied
11/10/2011
Date assigned
04/11/2011
Last edited
16/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Plantar fasciitis is a very common cause of heel pain. Typically the pain is worse in the mornings and after inactivity. The plantar fascia is a thick, strong band of elastic tissue on the sole of the foot which acts as a shock absorber and provides support for the arches of the foot.
Initial treatments include gel insoles or supports for the shoe or stretching exercises but for those patients in whom the pain persists, steroid injection is sometimes used as the next treatment step.
Despite this some people do not respond to these injections. We are not sure if this is because the injection is not in exactly the right place or because the steroid itself is not effective. This study has been designed to answer two questions 1) Does steroid injection really work 2) Are the results better if we use an ultrasound scanner (similar to that used for expectant mothers) to help with the injection?

Who can participate?
Patients aged over 18 years with a clinical diagnosis of plantar fasciitis will be invited to participate.

What does the study involve?
Patients will be asked to attend the rheumatology outpatient department in Musgrave Park Hospital, Belfast on three separate occasions.
On the first occasion, patients will be asked to complete a questionnaire, which will ask questions about heel pain, occupation and exercise. Patients will then be examined by a specialist rheumatology podiatrist who will take some foot measurements. Next a doctor will examine the foot using an ultrasound machine. This will be a painless procedure, where gel will be applied to the skin, and a smooth probe will be passed over the heel. Finally, patients will receive one of three treatment options:
1. Injection of heel with steroid (20mg methylprednisolone) (depomedrone) without ultrasound guidance (this has been the traditional approach)
2. Injection of heel with steroid (20mg methylprednisolone) (depomedrone) using ultrasound to guide the injection.
3. Injection of heel with sterile salt water (no steroid) using ultrasound guidance.
All three techniques will first use local anaesthetic to numb the heel so that it will be as painless as possible.
Patients will not know which treatment they are receiving so that we will be better able to work out the response (this is called a blinded study and it gives more accurate results). The doctor or podiatrist doing the assessments will not know what treatment the patient has received either.
On the second and third occasions, 6 weeks and 12 weeks after the injection, patients will be asked to complete another questionnaire, to assess how the injection has affected the pain. another ultrasound scan to assess the heel will be done.
The drug being tested is called methylprednisolone acetate, another name by which it may be known is Depomedrone. This drug has been used for the treatment of arthritis and heel pain for many years. The drug will be in a liquid form and is injected into the heel. Patients will be able to continue with all of their usual medication and painkillers.

What are the possible benefits and risks of participating?
The steroid injection may reduce the pain in the heel for a period of time or indeed longer. The information that we get from this study may help us to target the use of steroid injections in patients with heel pain and we hope to find out whether ultrasound is useful or not.
Steroid injections used in this study have been used in the treatment of arthritis and heel pain for many years. While joint injections of steroids are regarded as safe to use in patients with arthritis side effects can occur. Repeated or too many injections can cause shrinkage of the fat pad in the heel above the plantar fascia but this is very unusual. Also there is a theoretical risk of rupturing the plantar fascia with a steroid injection but again this happens only very very rarely. There is no risk with injecting sterile water. The use of ultrasound as an investigation has been in medicine for many years and there are no perceived side effects to this investigation.

Where is the study run from?
The study will take place within the Belfast Health and Social Care Trust and patients will be recruited from the Podiatry department and via GP referrals to the rheumatology service.

When is the study starting and how long is it expected to run for?
The study will run from 2008 until 2011.

Who is funding the study?
No external funding is being received. The Belfast Trust is paying for any incidental costs.

Who is the main contact?
Dr Elisabeth Ball
Elisabethball21@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Allister Taggart

ORCID ID

Contact details

Dept of Rheumatology
Musgrave Park Hospital
Stockman's Lane
Belfast
BT9 7JB
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A randomised placebo controlled trial to compare ultrasound guided with palpation guided steroid injection in plantar fasciitis

Acronym

Study hypothesis

The plantar fascia is a fibrous band on the undersurface of the foot which acts as a shock absorber and a support for the arches of the foot. It may become inflammed leading to fasciitis which manifests as severe localised heel pain which is typically worse in the mornings and after inactivity and worsens again with overuse. The pain is debilitating and has a significant impact on quality of life and work capacity.

To compare steroid injection with placebo in the management of plantar fasciitis, to compare ultrasound guided steroid injection with palpation guided steroid injection and to investigate the overall role of ultrasound in the management of plantar fasciitis.

Ethics approval

Ethical approval was obtained from the Northern Ireland Regional Ethics Committee ORECNI) in Aug 2008, Ref: 08/NIR01/47

Study design

Randomised double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please contact Dr Elisabeth Ball (Elisabethball21@gmail.com) to request a patient information sheet

Condition

Plantar fasciitis

Intervention

1. Ultrasound guided steroid group - patients will be given a steroid injection with the use of direct ultrasound guidance for needle insertion via the posterior heel approach
2. Palpation guided steroid injection - patients will be given a steroid injection via the posterior heel approach with the needle directed towards the area of maximum pain. A 'sham' ultrasound technique will be used in that the probe will be placed on the foot so that the patients will not be aware of which type of injection they are receiving.
3. Ultrasound guided placebo group - patients will receive an injection of sterile water under ultrasound guidance - syringes will be taped by an independent observer so that the investigator doing the injections is blinded as to whether he is injecting steroid or placebo

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Patient reported pain levels (Visual Analogue scale) at 6 weeks and 12 weeks

Secondary outcome measures

1. Heel Tenderness Index (assessed by the physician)
2. Ultrasound appearances of the plantar fascia at 6 weeks and 12 weeks

Overall trial start date

05/11/2008

Overall trial end date

17/06/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients aged over 18 with a clinical diagnosis of plantar fasciitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

90

Participant exclusion criteria

1. Any patients with a history of inflammatory arthritis or psoriasis
2. Who have ever previously received a steroid injection

Recruitment start date

05/11/2008

Recruitment end date

17/06/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Rheumatology
Belfast
BT9 7JB
United Kingdom

Sponsor information

Organisation

Belfast Health and Social Care Trust (UK)

Sponsor details

Research Support
King Edward Building
2 nd Floor
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

Belfast Health and Social Care Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22739993

Publication citations

  1. Results

    Ball EM, McKeeman HM, Patterson C, Burns J, Yau WH, Moore OA, Benson C, Foo J, Wright GD, Taggart AJ, Steroid injection for inferior heel pain: a randomised controlled trial., Ann. Rheum. Dis., 2013, 72, 6, 996-1002, doi: 10.1136/annrheumdis-2012-201508.

Additional files

Editorial Notes