Achilles TendinopathyNCT01583504
High Volume Saline Injections for Achilles Tendinopathy
A study testing Ultrasound guided injection of steroid and local anaesthetic, High volume saline injection and exercise programme in people with Achilles Tendinopathy, run by Leeds Comunity Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy
- What is being tested?
- Ultrasound guided injection of steroid and local anaesthetic, High volume saline injection and exercise programme
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2012to Mar 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- More than 13 weeks of pain in the achilles tendon area
- Completed eccentric tendon loading programme with a physiotherapist
- Achilles tendon tender to palpation in the midportion
- Tendon diameter greater than 0.7cm on ultrasound scan
- Evidence of neovascularisation on doppler ultrasound scan
- Sufficient English language to complete questionnaires and consent
Who cannot join
- Ultrasound evidence or previous history of partial or full tendon tear
- Another co-existing significant foot or ankle pathology
- Taking anticoagulant medication i.e: warfarin, clopidogrel, dipyridamole
- A medical condition that would affect safety of injection i.e. diabetic neuropathy, peripheral vascular disease
- Previous achilles tendon surgery
- unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Leeds Musculoskeletal and Rehabilitation Service
Leeds, W Yorks, LS7 4SA
Marie Hoddell, 0113 392 4802, marie.hoddell@leedsth.nhs.uk
About this study
Official title: A Double Blind, Randomised Controlled Trial of High Volume Saline Injections for Chronic Midportion Achilles Tendinopathy
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.
Objective 1: To establish whether high volume saline injections are an effective treatment in decreasing pain for people with achilles tendinopathy
Read more
Objective 2: To investigate whether high volume saline injections can improve day to day functioning, quality of life and the ultrasound appearances of the tendon for people with achilles tendinopathy
Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction using a simple questionnaire.
Objective 4: To follow up the cohort of people who have received the injection for 9 months and ascertain whether any benefits persisted, or if the symptoms recurred.
Background: Achilles tendon 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%.
Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing and swelling of the tendon. Symptoms may occur with exercise at first but can progress to occurring at rest and interfering with day to day activities. When the problematic tendon is examined under the microscope, it usually shows signs of degeneration rather than inflammation - especially when symptoms have been persistent. An ultrasound scan will usually show that the tendon is swollen with an increased water content and a disorganised tendon structure.
A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound, often shows areas of increased blood flow around the tendon. Studies have shown that when these areas of increased blood flow are present, the patient tends to be experiencing more pain and stiffness in the tendon. Under the microscope, these blood vessels are often accompanied by nerve fibres and it has been suggested that these newly growing nerve endings are responsible for the persistent pain that patients experience.
There is robust evidence that a particular type of exercise programme (eccentric loading) is an effective treatment for achilles tendinopathy. These exercises involve taking weight on the tendon whilst it is being compressed rather than stretched - heel lowering exercises. Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45% of patients will still have symptoms. There is no clear consensus amongst doctors as to what is the best second line treatment to try for this group of people.
A number of different treatments have been described in research literature to try to treat this group of people with persistent symptoms, although no firm conclusion can be reached. There have been 2 small trials of high volume saline injections which showed some promising potential for the treatment. The aim of this injection is to destroy the blood vessels and nerve endings that grow into the swollen tendon to reduce pain and allow people to move and exercise more normally using the tendon. These studies simply looked at before and after injection results and did not compare the injections to a placebo or other treatment. The aim of this project is to conduct a high quality comparison of this new type of injection against a more common steroid and local anaesthetic injection around the tendon sheath. The design of the trial is a double blind, randomised controlled trial. This means that neither the patient, nor the doctor collecting data on pain scores knows which treatment the participant has been given, allowing a fair comparison of the interventions.
The main comparisons between the 2 groups will take place at a 6 week follow up appointment. Once outcome measures have been recorded by the blinded assessor, the participant will then be told which arm of the study they are on. If they previously received the control injection (steroid and local anaesthetic only)and they still have symptoms, they will at this stage be offered the high volume saline injection as well. The investigators will then follow all of the study participants up for 9 months to ascertain whether people show a persistent benefit from the treatment, or whether symptoms subsequently return.
The full study protocol is available on request from the Principle Investigator, along with information leaflets, ethical approvals etc.
- Conditions
- Achilles Tendinopathy
- Being tested
- Ultrasound guided injection of steroid and local anaesthetic, High volume saline injection, exercise programme
- Keywords
- Achilles, Tendinopathy, Tendonitis, Injection
- Medical subject headings
- Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided injection of steroid and local anaestheticProcedure or surgery
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.
High volume saline injectionProcedure or surgery
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 programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High volume saline injection | Experimental | 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. Receives: Procedure: Ultrasound guided injection of steroid and local anaesthetic; Procedure: High volume saline injection; Behavioral: exercise programme |
| Control Arm | Active comparator | 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 will then be followed up at 12 and 40 weeks Receives: Procedure: Ultrasound guided injection of steroid and local anaesthetic; Behavioral: exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
100mm Visual Analogue 100mm Visual Analogue Pain Score
Pain scores between the 2 trial arms are compared 6 weeks post injection
Measured: 6 weeks post intervention
Secondary outcomes (5)
Foot and Ankle Outcome Score
A validated measure of function specifically for foot and ankle conditions. Scores from the 2 trial arms are compared at 6 weeks post injection
Measured: 6 weeks
EQ5D-3L
a widely used health status measure which will be used to compare the 2 study groups 6 weeks post injection
Measured: 6 weeks
Diameter of symptomatic achilles tendon by ultrasound scan
the diameters of the achilles tendons will be compared at 6 weeks between the 2 trial arms
Measured: 6 weeks
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 2 trial arms.
Measured: 6 weeks
all outcome measures
the cohort of patients will have all outcome measures reviewed at 12 and 40 weeks to ensure resolution of symptoms
Measured: 12 and 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles TendinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leeds Comunity Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Insitute of Health Research FSF funding
- Responsible party
- Principal investigator, Dr Matthew Smith, Leeds Comunity Healthcare NHS Trust
- Investigators
- James Brown, MB ChB, Study director, Leeds Musculoskeletal and Rehabilitation Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583504
- Sponsor's protocol ID
- 11/YH/0376
- Status last verified
- Apr 2012
- First submitted
- 20 Apr 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Randomised Controlled Trial of High Volume Saline Injections for Chronic Midportion Achilles Tendinopathy
- ClinicalTrials.gov ID
- NCT01583504
- Acronym / sponsor ID
- 11/YH/0376
- Conditions
- Achilles Tendinopathy
- Keywords
- Achilles, Tendinopathy, Tendonitis, Injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Leeds Comunity Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- National Insitute of Health Research FSF funding
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Objective 1: To establish whether high volume saline injections are an effective treatment in decreasing pain for people with achilles tendinopathy
Objective 2: To investigate whether high volume saline injections can improve day to day functioning, quality of life and the ultrasound appearances of the tendon for people with achilles tendinopathy
Objective 3: To assess the tolerability of the procedure and levels of patient satisfaction using a simple questionnaire.
Objective 4: To follow up the cohort of people who have received the injection for 9 months and ascertain whether any benefits persisted, or if the symptoms recurred.
Background: Achilles tendon 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%.
Tendinopathy is a condition which is characterised by pain, difficulty with weight bearing and swelling of the tendon. Symptoms may occur with exercise at first but can progress to occurring at rest and interfering with day to day activities. When the problematic tendon is examined under the microscope, it usually shows signs of degeneration rather than inflammation - especially when symptoms have been persistent. An ultrasound scan will usually show that the tendon is swollen with an increased water content and a disorganised tendon structure.
A special type of ultrasound scan which looks at fluid flows, called a doppler ultrasound, often shows areas of increased blood flow around the tendon. Studies have shown that when these areas of increased blood flow are present, the patient tends to be experiencing more pain and stiffness in the tendon. Under the microscope, these blood vessels are often accompanied by nerve fibres and it has been suggested that these newly growing nerve endings are responsible for the persistent pain that patients experience.
There is robust evidence that a particular type of exercise programme (eccentric loading) is an effective treatment for achilles tendinopathy. These exercises involve taking weight on the tendon whilst it is being compressed rather than stretched - heel lowering exercises. Nevertheless after completing a 3 month eccentric loading exercise programme, around 24-45% of patients will still have symptoms. There is no clear consensus amongst doctors as to what is the best second line treatment to try for this group of people.
A number of different treatments have been described in research literature to try to treat this group of people with persistent symptoms, although no firm conclusion can be reached. There have been 2 small trials of high volume saline injections which showed some promising potential for the treatment. The aim of this injection is to destroy the blood vessels and nerve endings that grow into the swollen tendon to reduce pain and allow people to move and exercise more normally using the tendon. These studies simply looked at before and after injection results and did not compare the injections to a placebo or other treatment. The aim of this project is to conduct a high quality comparison of this new type of injection against a more common steroid and local anaesthetic injection around the tendon sheath. The design of the trial is a double blind, randomised controlled trial. This means that neither the patient, nor the doctor collecting data on pain scores knows which treatment the participant has been given, allowing a fair comparison of the interventions.
The main comparisons between the 2 groups will take place at a 6 week follow up appointment. Once outcome measures have been recorded by the blinded assessor, the participant will then be told which arm of the study they are on. If they previously received the control injection (steroid and local anaesthetic only)and they still have symptoms, they will at this stage be offered the high volume saline injection as well. The investigators will then follow all of the study participants up for 9 months to ascertain whether people show a persistent benefit from the treatment, or whether symptoms subsequently return.
The full study protocol is available on request from the Principle Investigator, along with information leaflets, ethical approvals etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High volume saline injection | Experimental | Procedure: Ultrasound guided injection of steroid and local anaesthetic, Procedure: High volume saline injection, Behavioral: exercise programmePatients 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. |
| Control Arm | Active comparator | Procedure: Ultrasound guided injection of steroid and local anaesthetic, Behavioral: exercise programmePatients 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 will then be followed up at 12 and 40 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18+
- More than 13 weeks of pain in the achilles tendon area
- Completed eccentric tendon loading programme with a physiotherapist
- Achilles tendon tender to palpation in the midportion
- Tendon diameter greater than 0.7cm on ultrasound scan
Key exclusion criteria (6 listed)
- Ultrasound evidence or previous history of partial or full tendon tear
- Another co-existing significant foot or ankle pathology
- Taking anticoagulant medication i.e: warfarin, clopidogrel, dipyridamole
- A medical condition that would affect safety of injection i.e. diabetic neuropathy, peripheral vascular disease
- Previous achilles tendon surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided injection of steroid and local anaesthetic2mls 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 or surgery | Control Arm, High volume saline injection |
| High volume saline injectionAfter 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. | Procedure or surgery | High volume saline injection |
| exercise programmea 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. | Behavioural | Control Arm, High volume saline injection |
Primary outcome
100mm Visual Analogue 100mm Visual Analogue Pain Score
Time frame: 6 weeks post intervention
Pain scores between the 2 trial arms are compared 6 weeks post injection
5 secondary outcomes
Foot and Ankle Outcome Score
Time frame: 6 weeks
EQ5D-3L
Time frame: 6 weeks
Diameter of symptomatic achilles tendon by ultrasound scan
Time frame: 6 weeks
Neovascularisation grading
Time frame: 6 weeks
all outcome measures
Time frame: 12 and 40 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Brown, MB ChB study director
Leeds Musculoskeletal and Rehabilitation Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided injection of steroid and local anaesthetic, High volume saline injection and exercise programme in people with Achilles Tendinopathy, run by Leeds Comunity Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Smith, MBChB (0113 392 4802, matthewsmith@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
100mm Visual Analogue 100mm Visual Analogue Pain Score (time frame: 6 weeks post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.