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

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ClinicalTrials.gov Identifier: NCT02757664
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Nacime Salomão Barbachan Mansur, Federal University of São Paulo

Brief 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).


Condition or disease Intervention/treatment Phase
Achilles Tendinitis Tendinopathy Device: Shock Wave Therapy Other: Eccentric Exercises Device: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shock Wave Therapy, Associated to Eccentric Strengthening Versus Isolated Eccentric Strengthening for Treating Insertional Achilles Tendinopathy: Double Blinded Randomized Clinical Trial
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Tendinitis

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 Name: 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 Name: 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 Name: 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).




Primary Outcome Measures :
  1. VISA-A Score change [ Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks ]
    Victorian Institute of Sports Assessment - Achilles


Secondary Outcome Measures :
  1. VAS - Pain assessment (change) [ Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks ]
    Visual Analogue Scale

  2. 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

  3. SF-12 (change) [ Time Frame: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks ]
    Short Form (SF-12) Health Survey

  4. 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

  5. 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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757664


Locations
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Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04022-001
Sponsors and Collaborators
Federal University of São Paulo
Investigators
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Principal Investigator: Nacime SB Mansur, MD Researcher
Study Director: Marcel JS Tamaoki, PhD Researcher
Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nacime Salomão Barbachan Mansur, Medical Doctor, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02757664    
Other Study ID Numbers: 8094833648737701
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Indefinitely
Access Criteria: Validated researcher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nacime Salomão Barbachan Mansur, Federal University of São Paulo:
achilles
tendinopathy
Physical Therapy Modalities
High-Energy Shock Waves
Additional relevant MeSH terms:
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Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries