Condition category
Musculoskeletal Diseases
Date applied
28/05/2012
Date assigned
24/07/2012
Last edited
03/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Achilles tendon disorders (heel cord disorders) are a common problem for athletes with a lifetime risk of around 50%. They are also common for less active people with a lifetime risk of around 6%. Achilles Tendinopathy, caused by overuse of the heel cord, is a condition, causes pain, difficulty with weight bearing and performing usual activities and swelling. There is a well researched physiotherapy (physical therapy) program (called eccentric loading) which is highly effective for heel cord disorder. Most people will have major relief of symptoms if they follow this program. However there is no clear answer as to what the next best treatment is if physiotherapy fails. This study is testing an injection of saline (salty water) given around the heel cord to alleviate pain and comparing this against an injection of drugs.

Who can participate?
Any adult with heel cord disorder, who has ongoing symptoms despite completing a 3 month program of physiotherapy exercises. The diagnosis should be made by a clinician and be supported by scan evidence of a swollen heel cord. Participants should have sufficient knowledge of English language to read the information booklet and complete the questionnaires and be able to give voluntary consent.

What does the study Involve?
Participants will be randomly allocated to one of two groups: the new treatment group (high volume saline injection + steroid and local anaesthetic) or the active comparator group (just steroid and local anaesthetic injection). Both the participant and the doctor will not know which injection is being given. Each participant will have a stretching exercise regime demonstrated to them and will receive an advice booklet on how to recover following the injection. After the injection has been given, the participant will return and outcome measures will again be recorded. This allows us to fairly compare the symptoms in the 2 groups. The doctor will then reveal which injection was received. If the participant still has symptoms at this time and they belonged to the comparator group, they will be offered the saline injection at this time. We will then follow all participants up again after another 6 weeks and again 9 months later to see if symptoms are recurring at all.

What are the possible benefits and risks of participating?
Pilot research has shown a possible relief of symptoms from the saline injection. They will also have access to high quality rehabilitation advice at their appointments. A helpline number is given to all participants and calls will usually be returned within 24 hours. The risk of infection following soft tissue injections is usually around 1 in 2000. Any participant receiving a second injection would be exposed to this risk a second time. There is a theoretical risk of heel cord rupture, although this has never been reported and has never happened to our knowledge in our clinical service.

Where is the study run from?
The study is run by the Leeds Musculoskeletal and Rehabilitation Service which is a part of the Leeds Community Healthcare NHS Trust. The administration centre of the study is at Chapel Allerton Hospital in Leeds. Research clinics take place across the city of Leeds, predominantly at Wharfedale Hospital in Otley, north of Leeds.

When is the study starting and how long is it expected to run for?
The study began recruiting patients in March 201 2 which will be completed by March 2013. Follow up and data analysis is expected to be completed by March 2014 and publication of results will follow later that year.

Who is funding the study?
The study is financed from Flexibility and Sustainability Funding allocated to Leeds Community Healthcare NHS Trust by the National Institute of Health Research (NIHR), UK.

Who is the main contact?
Dr James Brown
james@sportsinjurymanager.co.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr James Brown

ORCID ID

Contact details

MSK Office
2nd Floor
Chapel Allerton Hospital
Chapeltown Rd
Leeds
LS7 4SA
United Kingdom
+44 (0)113 392 4802
james@sportsinjurymanager.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01583504

Protocol/serial number

11/YH/0376

Study information

Scientific title

A double blind, randomised controlled trial of High Volume Saline Injections for chronic midportion Achilles Tendinopathy

Acronym

HVSIAT

Study hypothesis

High volume saline injections are an effective pain relieving treatment for people with longstanding pain in the achilles tendon which has not improved with a physiotherapy programme

Ethics approval

National Research Ethics Service, West Yorkshire, Leeds East, 26/10/2011, ref:11/YH/0376

Study design

Double-blind randomised controlled trial and cohort study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Midportion Achilles Tendinopathy

Intervention

Experimental Arm: High volume saline injection

Patients randomised to this trial arm will receive an ultrasound guided steroid and local anaesthetic injection around the achilles tendon in the same way as the control arm patients. In addition they will receive an injected bolus of normal saline (through the same needle) of between 14-25ml until the new vessels seen on ultrasound scan disappear. They will be then given a programme of stretching and strengthening exercises in the same way as patients on the control arm.

Active Comparator: Control Arm

Patients on this trial arm will receive an ultrasound guided injection of steroid and local anaesthetic between Kager's fat pad and the achilles tendon. They will then be given a programme of stretching and strengthening exercises.

Patients on this trial arm will be offered the high volume saline injection at their 6 week follow up appointment after outcome measures have been taken by the blinded assessor.

The whole cohort of patients (control and treatment arms) will then be followed up at 12 and 40 weeks

Procedure descriptions:

Ultrasound guided injection of steroid and local anaesthetic

2mls of 0.5% Bupivocaine and 25mg of hydrocortisone given as a single bolus via a 21G needle using sterile technique. The injection will be placed into the space between Kagers fat pad and the anterior aspect of the achilles tendon, into the area of maximal neovascularisation as seen on ultrasound scan.

Procedure: High volume saline injection

After steroid and local anaesthetic has been delivered, a bolus of normal saline will also be infused into the space between Kager's fat pad and the achilles tendon through the same needle, using ultrasound guidance and sterile technique. At least 14mls will be given but up to 40mls could be used. Saline will be injected until the injector determines that the appearance of neovascularisation on ultrasound has disappeared.

Exercise programme

A bandage will be placed on the ankle for 48 hours and instructions given to rest the ankle. The patient will be verbally shown a programme of exercises to be done over the next 6 weeks to stretch the tendon and steadily build up load bearing on it. The exercises are also clearly shown on a leaflet which the patient takes home.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

100mm Visual Analogue Pain Score. Pain scores between the two trial arms are compared 6 weeks post injection

Secondary outcome measures

1. Foot and Ankle Outcome Score (FAOS): A validated measure of function specifically for foot and ankle conditions. Scores from the two trial arms are compared at 6 weeks post injection
2. EQ5D-3L, a widely used health status measure which will be used to compare the two study groups 6 weeks post injection
3. Diameter of symptomatic achilles tendon by ultrasound scan compared at 6 weeks between the two trial arms
4. Neovascularisation grading: A grading of the amount of new vessel growth into the tendon as seen on ultrasound scan will be compared at 6 weeks between the two trial arms
5. The cohort of patients will have all outcome measures reviewed at 12 and 40 weeks to ensure resolution of symptoms and to look for evidence of symptom recurrence following injection.

Overall trial start date

12/03/2012

Overall trial end date

12/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age: 18+
2. More than 13 weeks of pain in the Achilles tendon area
3. Ongoing symptoms despite completing an eccentric loading exercise programme with a physiotherapist
4. Achilles tendon is tender to palpation
5. Tendon diameter greater than 0.7cm on ultrasound scan (indicating tendinopathy)
6. Evidence of neovascularisation on doppler ultrasound scan
7. Sufficient English literacy skills to complete consent and questionnaires

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

44

Participant exclusion criteria

1. Ultrasound evidence of tendon tear, intrasubstance defect or a previous history of tendon tear
2. Another co existing significant foot or ankle pathology, i.e. symptomatic osteoarthritis
3. Taking anticoagulant medication, clopidogrel or dipyridamole
4. A medical condition that would make treatment unsafe i.e. peripheral neuropathy, peripheral vascular disease or active infection
5. Previous achilles tendon surgery
6. Unable to give informed consent

Recruitment start date

12/03/2012

Recruitment end date

12/03/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Chapel Allerton Hospital
Leeds
LS7 4SA
United Kingdom

Sponsor information

Organisation

Leeds Community Healthcare Trust (UK)

Sponsor details

Linda Dobrzanska
Research & Development Manager
NHS Leeds
Stockdale House - 2nd Floor
Headingley Business Park
Victoria Road
Leeds
LS6 1PF
United Kingdom
+44 (0)113 203 3473
Linda.dobrzanska@nhsleeds.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

UK National Institute of Health Research Flexibility and Sustainability Funding (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

Publication citations

Additional files

Editorial Notes