An interventional study of Exercise therapy in Achilles Tendinopathy, sponsored by Sports Surgery Clinic, Santry, Dublin. Completed at 1 site in Ireland. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Sports Surgery Clinic, Santry, Dublin · Not applicable, Interventional, and Treatment
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.
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:
397 studies on the registry are indexed under Tendinopathy; 77 are open to participants now.
This study's enrollment of 29 is below the median of 48 across 332 interventional studies indexed under Tendinopathy.
Browse Tendinopathy studies →Sports Surgery Clinic, Santry, Dublin is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A 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.
Other: Exercise therapy
A 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.
Other: Exercise therapy
A 12 week multi-stage exercise rehabilitation program
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.
Time frame: This will be assessed at week 6 and 12, as well as 6, 12 and 24 month follow-ups
Plantar flexor strength
Measured using isokinetic dynamometry to determine plantar flexor peak torque relative to bodyweight (Nm/kg) with 2 test protocols.
Time frame: This will be carried out at week 0, 6 and 12
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.
Time frame: This will be carried out at week 0, 6 and 12
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.
Time frame: This will be carried out at week 6 and 12
Ran from Jan 2020 to primary completion in Jan 2023, 36 months.
Of 174 non-industry interventional studies with no phase under Tendinopathy, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 36 months is above that.
Counting every sponsor, half of 183 studies reached it within 20 months; a quarter within 7 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Sports Surgery Clinic, Santry, Dublin