Comparison of a patient-specific, gradually progressive exercise program guided by clinical parameters with an eccentric exercise program in people with chronic mid portion achillestendinopathy;

The department of sports medicine at the Maxima Medical Centre has special
consulting hours focussing on Achilles tendon complaints. We see around 100
patients a year with an overuse injury of the Achillest endon (
Achillestendinopathy).
This is a common, often chronic injury in a heterogeneous patientgroup.
Achillestendinopathy is a clinical diagnosis based on the presence of the triad
of pain, swelling en decreased load capacity.

The injury is very common amongst runners and jumping athletes, but around 1/3
of the patients has a sedentary lifestyle (Longo 2009). Besides the
heterogenity of the population, the injury is also very heterogeneous.
The insertion and the mid-portion tendinopathy are considered as separate
entities, where the tendinopathy progresses in different stages (a continuum),
from reactive to failed healing and eventually degeneration (Cook & Purdam
2009).
This heterogenity makes the applying of the correct treatment a big challenge.

Remedial therapy is seen as the cornerstone of the treatment, where the
excentric programme of Alfredson (1998) is the best known. This form of
remedial therapy proved effective during several scientific studies, with a
decrease of pain ( decrease of VAS score of 4- 94%) and an increase of function
( increase of VISA-A-score of 37-111%) (Habets 2015). The long-term effects are
also reasonably good. An increase of 52% VISA A after one year has been
described (de Jonge 2008) as well as a decrease of pain with 42 % (Roos 2003).
The national guideline of the Sports Medicine Association advises therefore to
start with an excentric programme. However, the excentric remedial therapy does
not work for 24-45% (Alfredson & Lorentzon 2000, Longo 2009). The number of
non-responders is probably higher in non-athletes, than in athletes (Savana
2007).

During TendoMax consulting hours we often see patients with longterm complaints
and with whom the excentric remedial therapy didn't work (long-term). We
therefore (by necessity) developed our own multimodal programme, with the
general principle of adjusting the load to the load capacity. For this, we
use our own TendoMax exercise programme and load management. Additional, we add
some co-interventions (if indicated) : improving the bio-mechanics (shoe advice
and eventually fitting assesment for shoe soles), improving the functional
stability, eliminating moving disorders through manual therapy/medicine,
prolotherapy ( injections with a glucose solution) or the prescription of
NSAID's (Ibuprofen) and in exceptional cases Extracorporeal ShockWave Therapy.

Because a lot of people have already tried excentric exercise therapy when
consulting the TendoMax consulting hours, we found it necessary to optimize the
exercise therapy. We saw possibilities because theoretically, some observations
can be made on the exercise therapy according to Alfredson; It is not adjusted
to the individual patient (concerning load capacity and sporting history/wish).
There is virtually no trainingsregime in terms of frequency and intensity; with
no adjusting by means of clinical parameters. This is not patient-friendly, the
exercises are for most patients too painful and too heavy. Also, this way of
exercise therapy is in practice difficult to combine with the "rules" of
loadregulating (loadmanagement; load based on complaints, max. NPRS 4/10).
Possibly because of this the therapy compliance might also not be optimal. In
the reference literature the excentric remedial therapy compliance varies from
72% (>50% therapy compliance) (de Vos 2007) to only 27-50% with a therapy
compliance of > 75% (Yelland 2011, Roos 2004). Especially these aspects have
been integrated into the TendoMax remedial programme, based on basal
trainingfysiological principles (supercompensation, dosed overload, individual
variability, reversibility) best practices and recent literature. It has a
progressive build-up, where the in- and outflowlevel are adapted to (load
capacity of ) the patient. Guiding here are the clinical parameters (pain and
after response), that might possibly make the remedial therapy a less
painful/heavy experience and can be better combined with load management,
hopefully leading to a higher therapy compliance.
In addition we offer several excercises (adjusted to the patient and the phase
of the complaints), in order to train multiple properties of the tendon. With
this we hope to get better results in the long run.
A standard treatment duration with this programma can't be determined, because
it depends on the actual and desired load capacity of the Achilles tendon of
the patient. The scientific literature that supports our remedial practice
programme, relates particularly to literature on patellar tendinopathy. So it
seems that the isometric exercise appears to be antalgic (Rio 2014, v. Ark
2014, Naugle 2012) and the heavy slow resistance training
(concentric/excentric) shows in the short as well as in the long term an
improvement of the clinical parameters (pain and function) and leads to a good
patient satisfaction (Kongsgaard 2010). Silbernagel(2001) showed that combined
concentric/excentric excercises lead to clinical improvement with the
Achillestendinopathy.
A systematic review (Habets & van Cingel 2014) clarified that excentric
therapy, but also other forms of remedial therapy, are effective, but there
have been few studies into the optimal meaning of remedial therapy within the
treatment of Achillestendinopathy.
We now have approximately 2 years of experience with our own remedial therapy
programme and earlier ( unpublished ) research ( N=51) showed a statistical
significant increase of the VISA-A of 65 % (46,0 (+/- 19,2) to 75,7 (+/-
18,8)) and a decrease of the NPRS of 52 % (4,8 (+/- 2.1) to 2,3 (+/- 1,5))
after 16 weeks. Therefore in this research we would like to compare it directly
with the excentric therapy of Alfredson.

Our aim is to investigate whether our TendoMáx program (gardually increasing
loading program, guided by clinical parameters) is more effective in reducing
pain and improving function than an eccentric exercise program in patients with
a chronic mid-portion Achilles tendinopathy.

Design: Randomized controlled trial
Setting: TendoMáx, outpatient clinic for Achilles tendon injuries. Single
centre study.
Open study, blinding for evaluation.
Inclusion: 21-11-2016 en 21-11-2018.
Sample size: 62 patients.
Outcome measurements: AAS* , NPRS**, VISA-A***, patient satisfaction,
compliance (%)


* AAS score: Ankle Activity Score; A score based on level and type of sport.
** NPRS : Numeractic Pain Rating Scale. We use the NPRS for measuring the pain
just before and just after performing the exercises (in the first 4 weeks); but
we also use an average NPRS for the whole week, a score for the best en worst
moment during the week and a NPRS during a functional test.
*** VISA A: Victorian Institution Sports Assessment Achilles Questionnaire: a
valid measurement instrument for measuring Achilles tendon function

Eccentric exercise program:
Load progression is based on time, pain is not a restriction for exercise
therapy.

Phase 1: Strengthening. Heel drop with extended en bent knee. Starting with 2d
3x10 rep's (double leg) building up to 2d 3x13 rep's (single leg)
Phase 2: Strenghtening; Heel drop with extended en bent knee. Starting with 2d
3x15hh (single leg) and building up to extra weights (until 15kg)
Phase 3: Return to sport; If no complaints remained = return to sport.
Decreased complaints: gradually returning to sport, starting with increasing
exposure time and intensity during training and thereafter during a match.

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TendoMáx exercise program:
load progression is guided by clinical parameters (pain and morning stiffness)

Phase 1: Decreasing reactivity; Isometric heel raise, building up from 3d 3x30s
(doule leg) to 3d 3x45s (single leg)
Phase 2; Strength; Concentric heel raise/Excentrisch heel drop with extended
and bent knee. Building up from 2d 4x6rep's (double leg) to 2d 4x6 rep's +
extra weight up to 20% of body weight (sinlge leg). Moreover, a progressive
walking schedule is started.
Phase 3: Sportspecific exercises and building up maximal strength. Heel drop
starting with 1d3x15 rep's with 15RM- value to 1d3x 4rep's with 4RM- value.
Moreover, a progressive running schedule is started.
Phase 4: Gradually returning to sport, starting with increasing frequence,
exposure time and intensity during training and thereafter during a match.

Participants have to abide the exercise program.
Moreover participants should fill out online questionnaires;
- intake meeting: AAS, NPRS average, VISA-A
- week 1 t/m 4 (per e-mail, weekly): NPRS average, NPRS just before and after
exercises, compliance
- week 4 (per e-mailby phone): VISA A
- week 8 (appointment tendomax/per e-mail): VISA- A, compliance (week 5 t/m 8)
- week 12 (per e-mailby phone): VISA- A , compliance (week 9 t/m 12)
- week 16 (appointment tendomax)per e-mail): VISA-A, compliance (week 813 t/m
16), NPRS average, patient satisfaction
- week 24, 36 en 52 (by phoneper e-mail): VISA-A, NPRS average

Extra time investment:
- 10 times an online questionnaire per e-mail phone call (15-510 minutes) for
data collection
- 1 time an appointment with the investigator after the consultation at
TendoMax, (15 minutes); informing about study, randomisation and filling out
the questionnaires and procedure considering these questionnaires (15 minutes)

The only risk is a temporary increase in complaints. There is no risk of
complications or significant side-effects.