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Achilles TendinopathyNCT04384874

A Novel Multi-factorial Criteria-based Rehabilitation Program for Chronic Mid-portion Achilles Tendinopathy

A study testing Exercise therapy in people with Achilles Tendinopathy, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Sixty physically active patients (aged 18-45) with chronic mid-portion Achilles tendinopathy will be recruited to take part in the study. The patients will be diagnosed by a sports medicine doctor and an MRI scan and will be experiencing palpable Achilles pain at the time of inclusion. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Achilles Tendinopathy
What is being tested?
Exercise therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteIreland
Study dates
29 Jan 2020to 31 May 2023
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 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Diagnosed with mid-portion Achilles Tendinopathy by a sports medicine physician
  • Have experienced symptoms for more than 3 months and less than 3 years
  • Aged between 18-45 years,
  • Regularly perform running-based exercise more than twice per week

Who cannot join

  • Have a co-existing lower limb injury.
  • Have had another running-related injury in the previous 12 months.
  • Have had an Achilles injection in the past 6 months

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Sports Surgery Clinic

    Dublin, Leinster

Other trials in Ireland

About this study

Official title: SSC6 Versus Silbernagel Rehabilitation Program in Patients With Chronic Mid-portion Achilles Tendinopathy: A Randomised Control Trial

Sixty physically active patients (aged 18-45) with chronic mid-portion Achilles tendinopathy will be recruited to take part in the study. The patients will be diagnosed by a sports medicine doctor and an MRI scan and will be experiencing palpable Achilles pain at the time of inclusion. The patients will be randomized into either a group performing the Silbernagel combined concentric-eccentric program, or a group performing a novel multi-phase program with specific outcome measures. The study will assess the patients calf strength, reactive strength and running biomechanics at baseline, week's 6 and 12 of a rehabilitation program and be available for a 6 month, 12 month and 2 year follow-up interview. The VISA-A questionnaire will be the primary outcome measure and will be completed at each testing and follow-up session.

Read the detailed description

Achilles tendinopathy is an overuse injury commonly seen in sports and physical activities that involve running, jumping and hopping. Patients with Achilles tendinopathy experience pain, morning stiffness and reduced ability to exercise. This condition can last for several years in some cases.

Exercise therapy in the form of resistance training has been demonstrated to be the most effective rehabilitation tool to reduce pain and increase function in patients with Achilles tendinopathy. Patients often experience clinical improvements before any meaningful structural changes on MRI or ultrasound imaging are observed. Returning athletes back to competitive sport requires a progressive loading program to enable them to tolerate high stretch-shortening cycle loads appropriate to the demands of their sport.

The SSC6 rehabilitation program is a six-stage pathway with a focus on strength development of the local muscle-tendon unit and the kinetic chain, the development of power and kinetic strength, running biomechanics and running load modification. The progression through each phase is guided by objective outcome criteria based on pain and function, strength and performance tests and achieving individualised resistance load targets. The strength and power exercises are performed at high intensity three days per week with 48 hours recovery. The Silbernagel program is a four-phase involves a daily exercise program of lower intensity with progression through each phase guided by symptoms and function.

This study will compare the effectiveness of a comprehensive Achilles tendinopathy rehabilitation program with progression criteria with a common Achilles tendinopathy rehabilitation program. Sixty recreationally-active subjects aged between 18-45 years who meet the inclusion criteria, will be recruited to partake in this study. The subjects will be randomly assigned to one of two groups where they will undergo a multi-phase rehabilitation program. Data will be collected at baseline, 6 weeks and 12 weeks, to monitor pain and functional response, biomechanical and structural changes. At 6, 12 and 24 months following the commencement of the rehabilitation program, patients will be required to complete a follow-up questionnaire to monitor progress and any re-injury incidence that may have occurred.

The following testing protocols will be performed:

  1. VISA-A Questionnaire The VISA-A questionnaire has been shown to be a valid, reliable and easy to use outcome measure tool for intervention studies on Achilles tendinopathy. It consists of eight questions regarding pain and function during both daily living and sporting activities. The overall score is between 0-100 where higher scores represent reduced pain and improved function. An improvement of 21 points between 2 and 12 weeks of a rehabilitation program have been typically observed. The difference in VISA-A score between both training protocols from baseline testing to the outcome testing at 6 weeks, 12 weeks, 6 and 12 months; will formulate the primary outcome measure for this study.
  2. Ankle isokinetic testing Achilles tendinopathy has been associated with reduced plantar flexor strength. Isokinetic testing is commonly used to measure plantarflexor peak torque. The subjects will perform 2 isokinetic tests. In the first test the subjects will lie in a prone position in an isokinetic dynamometer with full knee extension and the foot securely strapped to a pedal a neutral ankle position (tibia perpendicular to the sole of the foot). The centre of rotation of the ankle axis will be aligned with the dynamometer. Subjects will be asked to perform a warm-up involving 5 sub maximal concentric plantarflexion and dorsiflexion contractions between 60-100% of their self-perceived MVC. The subjects will then be required to produce a maximal plantarflexion force 5 repetitions for 2 sets with a 1 minute rest between sets. In the second test the subjects will lie in supine position with the knee flexed to 80º in order to specifically test the peak torque of the soleus. The same warm-up protocol and sets and repetitions as the previous test will apply. Both tests will use a speed of 60º per second and operate through an ankle range of between 30º plantarflexion and 20º dorsiflexion.
  3. Running biomechanics Altered running biomechanics and muscle recruitment strategies have been highlighted in runners with Achilles tendinopathy. The subjects will be asked to run on the treadmill at a self-selected sub maximal speed. Using 3D motion analysis (Run 3D, Oxford, United Kingdom), a number of biomechanical variables will be measured. These include: vertical and leg stiffness, contact time, flight time, stride length, stride frequency and joint angular displacements from initial contact to mid stance phase.
  4. Hop testing Achilles tendon material properties contribute to stretch shortening cycle performance during hopping tasks. Reduced tendon mechanical properties, plantar flexor muscle rate of force development and deficits on a single leg horizontal hop have previously been observed in patients with Achilles tendinopathy. Jump height, ground contact time and reactive strength index (RSI) will be measured using a double and single leg drop jump. Vertical, leg and ankle joint stiffness will be calculated using a novel single leg hurdle hop test. A pilot study has previously been carried out on 10 healthy subjects prior to the commencement of the Achilles RCT study. Good to excellent reliability was found for of vertical stiffness, contact time, ground reaction force, hop distance and rebound distance and 3 trials were sufficient to obtain a true measure of performance across most variables.
  5. Subjective questionnaire After the completion of the rehabilitation program patients will be ask to provide feedback on the prescribed program and will complete a training diary where compliance and adherence to the program will be monitored.
Being tested
Exercise therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise therapyOther

    A 12 week multi-stage exercise rehabilitation program

Study groups in NCT04384874
Study groupRoleWhat they receive
Silbernagel combined concentric-eccentric programActive comparatorA graduated rehabilitation program using exercises with concentric and eccentric contractions and progressing to plyometric training. The exercises are performed daily with progression guided by pain symptoms. There is no specificity in prescribed exercise loading.
Receives: Other: Exercise therapy
SSC6ExperimentalA multi-stage rehabilitation program with focus on strength and reactive strength targets, as well as running gait re-training. These exercises will be initially carried out 3 days per week for the first 6 weeks with specific load targets prescribed.
Receives: Other: Exercise therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in VISA-A Questionnaire score

    This is a measure of pain and lower limb function associated with Achilles tendinopathy and a primary outcome measure will be the change in VISA-A questionnaire at various time points during the 12 week intervention and in the long-term follow-ups. A change of 20 points is typically observed after a rehabilitation program, while a 10 point increase is accepted as being clinically meaningful.

    Measured: This will be assessed at week 6 and 12, as well as 6, 12 and 24 month follow-ups

Secondary outcomes (3)
  1. Plantar flexor strength

    Measured using isokinetic dynamometry to determine plantar flexor peak torque relative to bodyweight (Nm/kg) with 2 test protocols.

    Measured: This will be carried out at week 0, 6 and 12

  2. Running biomechanics

    Using 3D motion analysis (Run 3D, Oxford, United Kingdom) a number of kinematic and spatiotemporal variables will be measured: contact time, flight time, stride length, stride frequency and joint angular displacements from initial contact to mid stance phase. Spring mass model characteristics and especially lower limb stiffness will be calculated using a validated equitation based on running speed, contact time, body mass and leg length dimensions. After a brief warm-up, the subject will be asked to run at a speed they feel that they could sustain for a 30 minute steady effort and data will be captured for 30 seconds. The running speed selected by the subject at baseline testing will be repeated for the two subsequent testing sessions.

    Measured: This will be carried out at week 0, 6 and 12

  3. Lower limb reactive strength

    Patients will be asked to perform a double and single leg vertical drop jump and a single leg horizontal rebound task to assess lower limb biomechanics and reactive strength qualities.

    Measured: This will be carried out at week 6 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2020
  2. Study start29 Jan 2020
  3. Primary completion30 Jan 2023
  4. Study completion31 May 2023

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04384874
Sponsor's protocol ID
SSC-Achilles-001
Status last verified
Apr 2024
First submitted
23 Apr 2020
Last updated
22 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Griffin C, Daniels K, Hill C, Franklyn-Miller A, Morin JB. A criteria-based rehabilitation program for chronic mid-portion Achilles tendinopathy: study protocol for a randomised controlled trial. BMC Musculoskelet Disord. 2021 Aug 14;22(1):695. doi: 10.1186/s12891-021-04553-6.

    PubMed 34391384

Questions about this trial

What is this clinical trial studying?

A study testing Exercise therapy in people with Achilles Tendinopathy, run by Sports Surgery Clinic, Santry, Dublin at 1 site in Ireland.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 22 Apr 2024. 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 Ireland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in VISA-A Questionnaire score (time frame: This will be assessed at week 6 and 12, as well as 6, 12 and 24 month follow-ups). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04384874, which also lists 1 linked publication.

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 22 Apr 2024.

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