Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave Therapy in the Insertional Achilles Tendinopathy
Condition: Achilles Tendinitis; Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      Background: There is no consensus regarding the treatment of insertional tendinopathies. The
      good results of the eccentric training in the management of the non-insertional Achilles
      tendinopathy were not reproducible in the insertional disease. Shock wave therapy is
      described as an alternative to these patients.

      Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents
      better results that the eccentric strengthening associated to placebo.

      Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the use
      of placebo, in parallel groups.

      Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be
      enrolled in a randomized trial. Participants will be divided in two groups, one containing
      the combination of shock wave and eccentric exercises as treatment and the other
      comprehending the exercises assembled to placebo. The assessment of outcomes will occur in 2,
      4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain,
      activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles
      [VISA-A] questionnaire).
    

Detailed description: 
      Introduction: The insertional tendinopathy occurs in the Achilles attachment to the
      tuberosity of the calcaneus bone and up to 2 cm proximal to the tuberosity. It is generally
      associated to a traction enthesophyte (upper spur), to Haglund deformity (pump bump) and to
      pre and retro achilles bursitis. Nowadays, it is considered that its cause is
      multi-factorial, comprehending mechanical, vascular, neural and genetic factors.
      Historically, the disease´s initial treatment is based on motor physiotherapy, via the
      eccentric strengthening of the tendon. If, on the one hand, the results for non-insertional
      tendinopathy were encouraging, 82% of them being duly successful, the insertional
      tendinopathy, on the other hand, produced a rate of improvement ranging between 32 and 67% of
      the patients, according to the present studies.

      The failure of the traditional treatment normally leads the patients to surgery frequently
      associated to complications, such as wound necrosis and tendon rupture. More recently, the
      therapy with shock waves is being used in the treatment of pseudo-arthrosis and several types
      of tendinopathy.

      Several studies showed the above mentioned effects of the shock wave therapy may
      theoretically stimulate neovascularization and of the collagen production that, besides being
      important in the healing process, also permits several clinical usages, such as the skin
      healing treatment, the pseudo-arthrosis and several tendinopathies, including the Achilles
      insertional tendinopathy. The shock wave therapy is being progressively more studied. Recent
      works have presented good results with the technique however; the evidences are still
      insufficient to represent a consensus regarding the indication of this treatment.

      The objective of the present study is compare the effectiveness of eccentric strengthening
      protocol with and without shockwave therapy considering the VISA-A.

      Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents
      better results that the eccentric strengthening associated to placebo.

      Material and Method Design Double blind randomized clinical trial, with the use of placebo,
      in parallel groups Setting The study will be conducted at Hospital São Paulo - University
      Hospital of UNIFESP (HSP-UNIFESP), in the Orthopedics and Traumatology Department (DOT) and
      in CPRT - Centre of Tissue Research and Regeneration (DOT/EPM-UNIFESP); linked to a FINEP
      project regarding Shock Waves.

      Inclusion Criteria: Older than 18 and younger than 65 years of age, both genders; Pain
      symptoms in the calcaneus tendon insertion region over the last three months; Clinical
      diagnosis: presence of pain at palpation of the tendinous insertion region in the calcaneus
      bone (and up to 2cm close to this region) and the occurrence of increase of the region´s
      volume; Indication of tendinopathy in the Ultra Sound done at the previous health center or
      by a certified doctor; Lateral X-ray view of the calcaneus, showing any of the associated
      conditions (Haglund, enthesophyte or intra-substantial calcification).

      Exclusion Criteria: Previous surgery involving the affected foot or ankle; History or
      documented evidence of autoimmune or peripheral vascular diseases; History or documented
      evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel
      syndrome).History or documented evidence of systemic inflammatory disease a (rheumatoid
      arthritis, spondylitis, Reiter Syndrome, etc.); Non-Insertional or mixed tendinopathy
      (insertional and non-insertional); Previous infiltration in the affected tendon over the six
      months preceding the initial assessment; Beginning of the present pain, due to a trauma;
      Gross or congenital deformity overweighting the triceps sural muscle, being the main
      aetiology of the present disease; Pregnancy; Any condition that represents a contraindication
      of the proposed therapies; Any physical or social limitation that makes the protocol
      continuation unviable; Impossibility or incapacity to sign the Free Informed Consent Form;
      History or documented evidence concerning the blood coagulation disorders (treatment with
      anti-coagulant, excluding aspirin); Use of heart pacemaker;

      Sampling: calculation considers a standard deviation of 16.2; the clinical difference to be
      detected corresponds to 3,3 with sampling error of 5%. It was calculated considering 93
      patients divided in two groups in a randomized way. The sampling amount was defined according
      to the methodology indicated in Attachment I, where, based on the Central Limit Theorem and
      Laws of Large Numbers, this sampling size guarantees the reliability of the statistics.

      Randomization: The randomization sequence will be generated via computing software
      (http://www.randomizer.org/form.htm), producing a list from 1 - x, and each number will be
      related to a sole treatment method. Investigators will perform a randomization with
      interchanged blocks, with the same number of patients in each group.

      Allocation: The patients will have to fill out an initial questionnaire in order to be
      selected (Attachment 1). After that, the assistant doctor will do the physical diagnostic
      examination of the patient. Then, the US and XRay procedures will take place, in order
      complete the diagnostic assessment. The patient will be included in the protocol and duly
      randomized after the diagnostic confirmation is done via anamnesis and physical examination,
      and also after completion of supplementary tests, signature of the Informed Consent Form, and
      fulfilment of all the inclusion criteria and non-adequacy to the exclusion criteria. The
      following data will be collected to do the epidemiological: analysis of the lesions and
      interventions: Body mass index, Sex, Age, Sports practice (Yes/No), Presence of Haglung
      Deformity (Y/N), and the Presence of Enthesophyte (Y/N). Each non-transparent sealed
      envelope, numbered from 1 to 93, will contain either a paper with the word "physiotherapy" or
      with the words "physiotherapy and shock wave". Each treatment method will have the same
      number of envelopes. The patients will be initially assessed individually, being randomized
      and allocated in the same way. The intervention procedures will be the same, with the same
      positioning and preparations, but differing regarding the existence of a support at the
      applicator head of the shock wave apparatus in the group of patients without shock wave.

      Blinding: Neither the patient nor the evaluator doctor will have access to the protocol test
      applied to each patient.

      The patient will be included in the study after the diagnostic confirmation is done by
      medical history and physical examination, and also after completion of subsidiary tests (US),
      signature of the Informed Consent Form, and fulfilment of all the inclusion criteria and
      non-adequacy to the exclusion criteria.

      Intervention: Utilization of shock waves: Appliance of US gel on the region that will receive
      the shock wave; Appliance of radial shock waves with the BLT600 equipment (BTL Medical
      Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and
      1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0) as
      described above, repeated on the second week after the first intervention (2nd week) and four
      weeks after the first intervention (4th week).

      Group without Shock wave: Appliance of US gel on the region that will receive the shock wave;
      Placing of the apparatus´ therapeutic head with the support that blocks the shock wave
      propagation directly on the appliance field; Appliance of radial shock waves with the BLT600
      equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to
      10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day
      of treatment (D0) as described above, repeated on the second week after the first
      intervention (2nd week) and four weeks after the first intervention (4th week).

      Eccentric Exercises The groups will be submitted to Alfredson eccentric strengthening
      protocol for 12 weeks, starting on the same day of the first appliance. The exercises will be
      shown to the patients by the assistant doctor, and a booklet (Attachment 2) will be handed
      out, with detailed explanation concerning the protocol to be followed.

      Secondary Conclusion: EVA (Visual Analogue Scale); AOFAS; SF-12; Algometry (pain threshold
      and VAS with 3kg) Follow up: The patients must return to the ambulatory for clinical
      assessment at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months and 6 months after the beginning
      of the protocol.

      Assessment Scores: The questionnaires VISA-A, EVA, AOFAS and SF-12 will be applied in the
      first consultation. The patient will be also assessed with the same questionnaires at the
      intervals of 1, 3 and 6 months of the protocol.

      Statistical Analysis: After collecting information we will define the results, with
      descriptive analysis for the quantitative variables (interval of 95% of reliability for the
      average/mean). The qualitative variables will require the Comparison of Two Proportions via
      relative frequency analysis. The Pearson Correlation will be used to check the relation
      between quantitative variables, and the Chi-Square test will be utilized in relation to
      qualitative variables. The ANOVA test will be used to compare the two techniques based on
      their average.
    

Intervention name(s): Shock Wave Therapy; Eccentric Exercises; Placebo
Intervention type(s): Device; Other; Device
Intervention description(s): Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).; 12 weeks, starting on the same day of the first appliance. The patient will practice the exercises standing on tiptoes and will perform exercises of passive ankle extension (dorsiflexion), three series of 15 repetitions, with the knee stretched, and three series of 15 repetitions with the knee flexed by 20 degrees.; Placing of the apparatus´ therapeutic head with the support that impedes the shock wave propagation directly on the appliance field; Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).
Other intervention name(s): radial shock waves; Alfredson eccentric strengthening protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: achilles; tendinopathy; Physical Therapy Modalities; High-Energy Shock Waves