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

NCT02757664 | Completed DMC

• 1 other identifier: 8094833648737701
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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).

Conditions

Achilles Tendinitis; Tendinopathy

Keywords

achilles; tendinopathy; Physical Therapy Modalities; High-Energy Shock Waves

Outcome Measures

Primary Outcomes (1)

• VISA-A Score change

  Victorian Institute of Sports Assessment - Achilles

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

Secondary Outcomes (5)

• VAS - Pain assessment (change)

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

• AOFAS Hindfoot Scale (change)

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

• SF-12 (change)

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

• Pain threshold at Algometry (change)

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

• VAS with 3kg of pressure in the Algometer (change)

  0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks

Study Arms (2)

Shock wave plus eccentric exercises

ACTIVE COMPARATOR

Shock wave therapy associated with eccentric exercises rehabilitation program.

Device: Shock Wave Therapy; Other: Eccentric Exercises

Placebo plus eccentric exercises

PLACEBO COMPARATOR

Placebo associated with eccentric exercises rehabilitation program.

Other: Eccentric Exercises; Device: Placebo

Interventions

Shock Wave Therapy DEVICE

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).

Also known as: radial shock waves

Shock wave plus eccentric exercises

Eccentric Exercises OTHER

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.

Also known as: Alfredson eccentric strengthening protocol

Placebo plus eccentric exercises; Shock wave plus eccentric exercises

Placebo DEVICE

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).

Placebo plus eccentric exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04022-001, Brazil

Location

Related Publications (33)

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  PMID: 19857838 BACKGROUND

• Irwin TA. Current concepts review: insertional achilles tendinopathy. Foot Ankle Int. 2010 Oct;31(10):933-9. doi: 10.3113/FAI.2010.0933. No abstract available.

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• Wang CJ, Wang FS, Yang KD, Weng LH, Hsu CC, Huang CS, Yang LC. Shock wave therapy induces neovascularization at the tendon-bone junction. A study in rabbits. J Orthop Res. 2003 Nov;21(6):984-9. doi: 10.1016/S0736-0266(03)00104-9.

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• Al-Abbad H, Simon JV. The effectiveness of extracorporeal shock wave therapy on chronic achilles tendinopathy: a systematic review. Foot Ankle Int. 2013 Jan;34(1):33-41. doi: 10.1177/1071100712464354.

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• Notarnicola A, Moretti B. The biological effects of extracorporeal shock wave therapy (eswt) on tendon tissue. Muscles Ligaments Tendons J. 2012 Jun 17;2(1):33-7. Print 2012 Jan.

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  PMID: 18171957 BACKGROUND

• Furia JP. High-energy extracorporeal shock wave therapy as a treatment for chronic noninsertional Achilles tendinopathy. Am J Sports Med. 2008 Mar;36(3):502-8. doi: 10.1177/0363546507309674. Epub 2007 Nov 15.

  PMID: 18006678 BACKGROUND

• Rompe JD, Nafe B, Furia JP, Maffulli N. Eccentric loading, shock-wave treatment, or a wait-and-see policy for tendinopathy of the main body of tendo Achillis: a randomized controlled trial. Am J Sports Med. 2007 Mar;35(3):374-83. doi: 10.1177/0363546506295940. Epub 2007 Jan 23.

  PMID: 17244902 BACKGROUND

• Furia JP. High-energy extracorporeal shock wave therapy as a treatment for insertional Achilles tendinopathy. Am J Sports Med. 2006 May;34(5):733-40. doi: 10.1177/0363546505281810.

  PMID: 16627628 BACKGROUND

• Costa ML, Shepstone L, Donell ST, Thomas TL. Shock wave therapy for chronic Achilles tendon pain: a randomized placebo-controlled trial. Clin Orthop Relat Res. 2005 Nov;440:199-204. doi: 10.1097/01.blo.0000180451.03425.48.

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• Furia JP. [Extracorporeal shockwave therapy in the treatment of chronic insertional Achilles tendinopathy]. Orthopade. 2005 Jun;34(6):571-8. doi: 10.1007/s00132-005-0806-9. German.

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• Perlick L, Schiffmann R, Kraft CN, Wallny T, Diedrich O. [Extracorporal shock wave treatment of the achilles tendinitis: Experimental and preliminary clinical results]. Z Orthop Ihre Grenzgeb. 2002 May-Jun;140(3):275-80. doi: 10.1055/s-2002-32475. German.

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• Wang CJ, Chen HS, Chen CE, Yang KD. Treatment of nonunions of long bone fractures with shock waves. Clin Orthop Relat Res. 2001 Jun;(387):95-101. doi: 10.1097/00003086-200106000-00013.

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• Wang CJ, Huang HY, Chen HH, Pai CH, Yang KD. Effect of shock wave therapy on acute fractures of the tibia: a study in a dog model. Clin Orthop Relat Res. 2001 Jun;(387):112-8. doi: 10.1097/00003086-200106000-00015.

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• Meirer R, Kamelger FS, Huemer GM, Wanner S, Piza-Katzer H. Extracorporal shock wave may enhance skin flap survival in an animal model. Br J Plast Surg. 2005 Jan;58(1):53-7. doi: 10.1016/j.bjps.2004.04.027.

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• Sayana MK, Maffulli N. Eccentric calf muscle training in non-athletic patients with Achilles tendinopathy. J Sci Med Sport. 2007 Feb;10(1):52-8. doi: 10.1016/j.jsams.2006.05.008. Epub 2006 Jul 7.

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• Fahlstrom M, Jonsson P, Lorentzon R, Alfredson H. Chronic Achilles tendon pain treated with eccentric calf-muscle training. Knee Surg Sports Traumatol Arthrosc. 2003 Sep;11(5):327-33. doi: 10.1007/s00167-003-0418-z. Epub 2003 Aug 26.

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• Ohberg L, Alfredson H. Effects on neovascularisation behind the good results with eccentric training in chronic mid-portion Achilles tendinosis? Knee Surg Sports Traumatol Arthrosc. 2004 Sep;12(5):465-70. doi: 10.1007/s00167-004-0494-8. Epub 2004 Apr 2.

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• Kearney R, Costa ML. Insertional achilles tendinopathy management: a systematic review. Foot Ankle Int. 2010 Aug;31(8):689-94. doi: 10.3113/FAI.2010.0689.

  PMID: 20727317 RESULT

• Sussmilch-Leitch SP, Collins NJ, Bialocerkowski AE, Warden SJ, Crossley KM. Physical therapies for Achilles tendinopathy: systematic review and meta-analysis. J Foot Ankle Res. 2012 Jul 2;5(1):15. doi: 10.1186/1757-1146-5-15.

  PMID: 22747701 RESULT

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  PMID: 21406328 RESULT

• Hart L. Shock-wave treatment was more effective than eccentric training for chronic insertional achilles tendinopathy. Clin J Sport Med. 2009 Mar;19(2):152-3. doi: 10.1097/01.jsm.0000347357.41069.27. No abstract available.

  PMID: 19451774 RESULT

• Rompe JD, Furia J, Maffulli N. Eccentric loading versus eccentric loading plus shock-wave treatment for midportion achilles tendinopathy: a randomized controlled trial. Am J Sports Med. 2009 Mar;37(3):463-70. doi: 10.1177/0363546508326983. Epub 2008 Dec 15.

  PMID: 19088057 RESULT

• Rasmussen S, Christensen M, Mathiesen I, Simonson O. Shockwave therapy for chronic Achilles tendinopathy: a double-blind, randomized clinical trial of efficacy. Acta Orthop. 2008 Apr;79(2):249-56. doi: 10.1080/17453670710015058.

  PMID: 18484252 RESULT

• Mafi N, Lorentzon R, Alfredson H. Superior short-term results with eccentric calf muscle training compared to concentric training in a randomized prospective multicenter study on patients with chronic Achilles tendinosis. Knee Surg Sports Traumatol Arthrosc. 2001;9(1):42-7. doi: 10.1007/s001670000148.

  PMID: 11269583 RESULT

• Mansur NS, Faloppa F, Belloti JC, Ingham SJ, Matsunaga FT, Santos PR, Santos BS, Carrazzone OL, Peixoto G, Aoyama BT, Tamaoki MJ. Shock wave therapy associated with eccentric strengthening versus isolated eccentric strengthening for Achilles insertional tendinopathy treatment: a double-blinded randomised clinical trial protocol. BMJ Open. 2017 Jan 27;7(1):e013332. doi: 10.1136/bmjopen-2016-013332.

  PMID: 28132005 DERIVED

MeSH Terms

Conditions

Tendinopathy

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Nacime SB Mansur, MD

  Researcher

  PRINCIPAL INVESTIGATOR

• Marcel JS Tamaoki, PhD

  Researcher

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 2, 2016
• Study Start: February 1, 2017
• Primary Completion: April 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Indefinitely
• Access Criteria: Validated researcher

Locations

BR (1)