Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave Therapy in the Insertional Achilles Tendinopathy

June 15, 2020 updated by: Nacime Salomão Barbachan Mansur, Federal University of São Paulo

Shock Wave Therapy, Associated to Eccentric Strengthening Versus Isolated Eccentric Strengthening for Treating Insertional Achilles Tendinopathy: Double Blinded Randomized Clinical Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 04022-001
        • Federal University of São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.)
  • History or documented evidence of loss of sensibility in the foot or ankle;
  • 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;
  • Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;
  • Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling;
  • Tumour lesions (primary or secondary tumours).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Shock wave plus eccentric exercises
Shock wave therapy associated with eccentric exercises rehabilitation program.
Device: Shock Wave Therapy
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 Names:
  • radial shock waves
Other: Eccentric Exercises
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.
Other Names:
  • Alfredson eccentric strengthening protocol
Placebo Comparator: Placebo plus eccentric exercises
Placebo associated with eccentric exercises rehabilitation program.
Other: Eccentric Exercises
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.
Other Names:
  • Alfredson eccentric strengthening protocol
Device: Placebo
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VISA-A Score change
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Victorian Institute of Sports Assessment - Achilles
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS - Pain assessment (change)
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Visual Analogue Scale
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
AOFAS Hindfoot Scale (change)
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
American Orthopaedic Foot and Ankle Society Hindfoot Scale
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
SF-12 (change)
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Short Form (SF-12) Health Survey
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Pain threshold at Algometry (change)
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Algometry in the most painful point at the participant's heel
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
VAS with 3kg of pressure in the Algometer (change)
Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Pain assessment by Visual Analogue Scale with 3kg of pressure in the most painful point at the participant's heel
0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Nacime SB Mansur, MD, Researcher
  • Study Director: Marcel JS Tamaoki, PhD, Researcher

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2017

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

April 26, 2016

First Submitted That Met QC Criteria

April 27, 2016

First Posted (Estimate)

May 2, 2016

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 15, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8094833648737701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

According to the ICMJE data sharing police, the datasets supporting the conclusions of this article are available at DataDryard (Mansur, Nacime Salomão Barbachan; Tamaoki, Marcel Jun Sugawara (2020), SHOCK WAVE THERAPY ASSOCIATED WITH ECCENTRIC STRENGTHENING VERSUS ISOLATED ECCENTRIC STRENGTHENING FOR ACHILLES INSERTIONAL TENDINOPATHY TREATMENT: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL, Dryad Dataset, https://doi.org/10.5061/dryad.jq2bvq86k) and available upon request.

IPD Sharing Time Frame

Indefinitely

IPD Sharing Access Criteria

Validated researcher

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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