Achilles Tendinopathy; the Effect of Shockwave Treatment

NCT07685509 | Not Yet Recruiting

• 2 other identifiers: 2026-01721-01P2026-0030
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

BACKGROUND Achilles tendinopathy-pain in the Achilles tendon-is a common and often long-lasting condition that limits physical activity and performance, and also affects work capacity and quality of life. The pain is localized either to the mid- portion of the tendon or at its insertion into the calcaneus. Although individually tailored exercise is the first-line treatment, symptoms persist in many patients, highlighting the need for adjunctive therapies. AIM This interdisciplinary and innovative research project aims to evaluate the effect of shockwave therapy in Achilles tendinopathy, both in cases where the pain is located in the mid-portion of the tendon and where it is situated at the tendon's insertion. In addition to assessing effects on pain and function, the study will examine the impact on calcifications, neovascularization (evaluated via Doppler ultrasound), and-uniquely-systemic immunological effects, with a focus on NK cells in the blood, an area that remains largely unexplored. METHOD This is a randomized controlled trial (RCT) with four arms, including 200 patients divided into two groups based on pain location. Half of the participants will receive adjunctive shockwave therapy in six sessions, in addition to exercise following the protocol by Silbernagel et al. The primary outcome measure is self-reported pain assessed using the Numeric Rating Scale (NRS) 0-10 at 12 months. Secondary outcomes include function, assessed through patient-reported outcomes (Victorian Institute of Sport Assessment-Achilles Swedish version, VISA-AS), calf muscle strength and endurance, and jumping ability using a validated test battery. Neovascularization and tendon cross-sectional area will be evaluated using ultrasound/Doppler. In a sub-cohort, immune cell composition in blood will be analyzed using flow cytometry before and after treatment. For patients undergoing surgery, tissue samples will also be collected for cellular composition analysis. SIGNIFICANCE This project has the potential to improve treatment strategies, reduce the need for surgery, and generate entirely new knowledge about the relationship between local tissue pathology and systemic immune responses.

Conditions

Achilles Tendinopathy (AT); Achilles Tendon; Achilles Tendon Pain

Keywords

Achilles Tendinopathy; Shockwave; Insertional Achilles Tendinopathy; Exercise; Heel-rise

Outcome Measures

Primary Outcomes (1)

• Change in self-reported pain from baseline to 12 months after treatment start

  Zero is equivalent to no pain and 10 indicates the worst possible pain.

  At baseline and after 12 months after enrollment

Secondary Outcomes (12)

• Change in self-reported pain 3 and 6 months after treatment start

  At baseline and after 3 and 6 months after enrollment

• Rate of blood vessels in the Achilles tendon

  At baseline and after 3, 6, and 12 month

• Achilles Tendon cross-sectional area

  At baseline and after 3, 6 and 12 months

• Physical Activity Scale (PAS)

  At baseline and after 3,6 and 12 months

• VISA-AS

  At baseline and after 3, 6 and 12 months

Other Outcomes (1)

• Blood samples will be collected to assess changes in immune cell composition, focusing on NK and CD8+ T cells.

  At baseline and after 4-6 weeks

Study Arms (4)

Achilles Tendinopathy, exercise therapy and additional treatment with shockwave

EXPERIMENTAL

Patients with Achilles Tendinopathy receiving exercise therapy with regular follow-ups and additional treatment with shockwave.

Device: individually tailored exercises and Radial Shockwave

Achilles Tendinopathy, exercise therapy

ACTIVE COMPARATOR

Patients with Achilles Tendinopathy receiving exercise therapy with regular follow-ups

Other: Individually tailored exercises

Insertional Achilles Tendinopathy, exercise therapy and additional treatment with shockwave

EXPERIMENTAL

Patients with Insertional Achilles Tendinopathy receiving exercise therapy with regular follow-ups and additional treatment with shockwave.

Device: individually tailored exercises and Radial Shockwave

Insertional Achilles Tendinopathy, exercise therapy

ACTIVE COMPARATOR

Patients with Insertional Achilles Tendinopathy receiving exercise therapy with regular follow-ups

Other: Individually tailored exercises

Interventions

individually tailored exercises and Radial Shockwave DEVICE

Shockwave: 5-6 treatments with radial shockwave, 10 bar, 2000-4000 pulses as an additional treatment to individually tailored exercises.

Achilles Tendinopathy, exercise therapy and additional treatment with shockwave; Insertional Achilles Tendinopathy, exercise therapy and additional treatment with shockwave

Individually tailored exercises OTHER

Individually tailored exercises

Achilles Tendinopathy, exercise therapy; Insertional Achilles Tendinopathy, exercise therapy

Eligibility Criteria

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

You may qualify if:

• Women and men over 18 years of age who seek care for load-related pain in the midportion of the Achilles tendon or at the Achilles tendon insertion at a Physiotherapy Clinic in Primary Care, at the Physiotherapy Department at Sahlgrenska University Hospital/Mölndal, or at the Orthopedic Department at Sahlgrenska University Hospital/Mölndal.
• Symptoms must have been present for one month or longer.
• Symptoms may be present in one or both Achilles tendons.

You may not qualify if:

• Unwillingness to receive shockwave therapy.
• Previous shockwave therapy for Achilles tendon pain within the past year.
• Neurological disease, significant cardiac conditions, increased bleeding tendency, treatment with anticoagulant medication, pregnancy, or presence of a tumor in the foot.
• Corticosteroid injection in the foot within the past six months.
• Reduced sensation, acute inflammation, or any wound around the heel.
• Inability to understand or speak Swedish.

Sponsors & Collaborators

• Göteborg University: collaborator
• Vastra Gotaland Region: lead

Related Publications (24)

• Silbernagel KG, Thomee R, Karlsson J. Cross-cultural adaptation of the VISA-A questionnaire, an index of clinical severity for patients with Achilles tendinopathy, with reliability, validity and structure evaluations. BMC Musculoskelet Disord. 2005 Mar 6;6:12. doi: 10.1186/1471-2474-6-12.

  PMID: 15748297 BACKGROUND

• Silbernagel KG, Gustavsson A, Thomee R, Karlsson J. Evaluation of lower leg function in patients with Achilles tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2006 Nov;14(11):1207-17. doi: 10.1007/s00167-006-0150-6. Epub 2006 Jul 21.

  PMID: 16858560 BACKGROUND

• Jonsson P, Alfredson H, Sunding K, Fahlstrom M, Cook J. New regimen for eccentric calf-muscle training in patients with chronic insertional Achilles tendinopathy: results of a pilot study. Br J Sports Med. 2008 Sep;42(9):746-9. doi: 10.1136/bjsm.2007.039545. Epub 2008 Jan 9.

  PMID: 18184750 BACKGROUND

• Farrar JT, Young JP Jr, LaMoreaux L, Werth JL, Poole MR. Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain. 2001 Nov;94(2):149-158. doi: 10.1016/S0304-3959(01)00349-9.

  PMID: 11690728 BACKGROUND

• Santamato A, Beatrice R, Micello MF, Fortunato F, Panza F, Bristogiannis C, Cleopazzo E, Macarini L, Picelli A, Baricich A, Ranieri M. Power Doppler Ultrasound Findings before and after Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Pilot Study on Pain Reduction and Neovascularization Effect. Ultrasound Med Biol. 2019 May;45(5):1316-1323. doi: 10.1016/j.ultrasmedbio.2018.12.009. Epub 2019 Feb 8.

  PMID: 30739723 BACKGROUND

• Cheng Y, Zhang J, Cai Y. Utility of Ultrasonography in Assessing the Effectiveness of Extracorporeal Shock Wave Therapy in Insertional Achilles Tendinopathy. Biomed Res Int. 2016;2016:2580969. doi: 10.1155/2016/2580969. Epub 2016 Nov 28.

  PMID: 28004000 BACKGROUND

• Gatz M, Schweda S, Betsch M, Dirrichs T, de la Fuente M, Reinhardt N, Quack V. Line- and Point-Focused Extracorporeal Shock Wave Therapy for Achilles Tendinopathy: A Placebo-Controlled RCT Study. Sports Health. 2021 Sep-Oct;13(5):511-518. doi: 10.1177/1941738121991791. Epub 2021 Feb 13.

  PMID: 33586526 BACKGROUND

• Charles R, Fang L, Zhu R, Wang J. The effectiveness of shockwave therapy on patellar tendinopathy, Achilles tendinopathy, and plantar fasciitis: a systematic review and meta-analysis. Front Immunol. 2023 Aug 16;14:1193835. doi: 10.3389/fimmu.2023.1193835. eCollection 2023.

  PMID: 37662911 BACKGROUND

• Feeney KM. The Effectiveness of Extracorporeal Shockwave Therapy for Midportion Achilles Tendinopathy: A Systematic Review. Cureus. 2022 Jul 18;14(7):e26960. doi: 10.7759/cureus.26960. eCollection 2022 Jul.

  PMID: 35989757 BACKGROUND

• Paantjens MA, Helmhout PH, Backx FJG, van Etten-Jamaludin FS, Bakker EWP. Extracorporeal Shockwave Therapy for Mid-portion and Insertional Achilles Tendinopathy: A Systematic Review of Randomized Controlled Trials. Sports Med Open. 2022 May 13;8(1):68. doi: 10.1186/s40798-022-00456-5.

  PMID: 35552903 BACKGROUND

• Stania M, Mala J, Chmielewska D. The Efficacy of Extracorporeal Shock Wave Therapy as a Monotherapy for Achilles Tendinopathy: A Systematic Review and Meta-Analysis. J Chiropr Med. 2023 Dec;22(4):294-301. doi: 10.1016/j.jcm.2023.04.003. Epub 2023 Jun 14.

  PMID: 38205224 BACKGROUND

• Pinitkwamdee S, Laohajaroensombat S, Orapin J, Woratanarat P. Effectiveness of Extracorporeal Shockwave Therapy in the Treatment of Chronic Insertional Achilles Tendinopathy. Foot Ankle Int. 2020 Apr;41(4):403-410. doi: 10.1177/1071100719898461. Epub 2020 Jan 10.

  PMID: 31924120 BACKGROUND

• Mansur NSB, Matsunaga FT, Carrazzone OL, Schiefer Dos Santos B, Nunes CG, Aoyama BT, Dias Dos Santos PR, Faloppa F, Tamaoki MJS. Shockwave Therapy Plus Eccentric Exercises Versus Isolated Eccentric Exercises for Achilles Insertional Tendinopathy: A Double-Blinded Randomized Clinical Trial. J Bone Joint Surg Am. 2021 Jul 21;103(14):1295-1302. doi: 10.2106/JBJS.20.01826.

  PMID: 34029235 BACKGROUND

• Butler JJ, DeClouette B, Azam MT, Walls RC, Jejelava G, Zheng D, Jia N, Kennedy JG. Outcomes After Extracorporeal Shockwave Therapy for Chronic Noninsertional Achilles Tendinopathy Compared With Chronic Insertional Achilles Tendinopathy: A Retrospective Review. Orthop J Sports Med. 2024 Sep 4;12(9):23259671241265330. doi: 10.1177/23259671241265330. eCollection 2024 Sep.

  PMID: 39247530 BACKGROUND

• Abdelkader NA, Helmy MNK, Fayaz NA, Saweeres ESB. Short- and Intermediate-Term Results of Extracorporeal Shockwave Therapy for Noninsertional Achilles Tendinopathy. Foot Ankle Int. 2021 Jun;42(6):788-797. doi: 10.1177/1071100720982613. Epub 2021 Jan 15.

  PMID: 33451253 BACKGROUND

• Rompe JD, Furia J, Maffulli N. Eccentric loading compared with shock wave treatment for chronic insertional achilles tendinopathy. A randomized, controlled trial. J Bone Joint Surg Am. 2008 Jan;90(1):52-61. doi: 10.2106/JBJS.F.01494.

  PMID: 18171957 BACKGROUND

• 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 BACKGROUND

• Beyer R, Kongsgaard M, Hougs Kjaer B, Ohlenschlaeger T, Kjaer M, Magnusson SP. Heavy Slow Resistance Versus Eccentric Training as Treatment for Achilles Tendinopathy: A Randomized Controlled Trial. Am J Sports Med. 2015 Jul;43(7):1704-11. doi: 10.1177/0363546515584760. Epub 2015 May 27.

  PMID: 26018970 BACKGROUND

• Silbernagel KG, Thomee R, Thomee P, Karlsson J. Eccentric overload training for patients with chronic Achilles tendon pain--a randomised controlled study with reliability testing of the evaluation methods. Scand J Med Sci Sports. 2001 Aug;11(4):197-206. doi: 10.1034/j.1600-0838.2001.110402.x.

  PMID: 11476424 BACKGROUND

• Alfredson H, Pietila T, Jonsson P, Lorentzon R. Heavy-load eccentric calf muscle training for the treatment of chronic Achilles tendinosis. Am J Sports Med. 1998 May-Jun;26(3):360-6. doi: 10.1177/03635465980260030301.

  PMID: 9617396 BACKGROUND

• Verges J, Martinez N, Pascual A, Bibas M, Santina M, Rodas G. Psychosocial and individual factors affecting Quality of Life (QoL) in patients suffering from Achilles tendinopathy: a systematic review. BMC Musculoskelet Disord. 2022 Dec 21;23(1):1114. doi: 10.1186/s12891-022-06090-2.

  PMID: 36544133 BACKGROUND

• Kenyon M, Driver P, Mallows A, Stephens G, Bryant M, Al Dawoud M, O'Neill S. Characteristics of patients seeking national health service (NHS) care for Achilles tendinopathy: A service evaluation of 573 patients. Musculoskelet Sci Pract. 2024 Nov;74:103156. doi: 10.1016/j.msksp.2024.103156. Epub 2024 Sep 4.

  PMID: 39270530 BACKGROUND

• de Jonge S, van den Berg C, de Vos RJ, van der Heide HJ, Weir A, Verhaar JA, Bierma-Zeinstra SM, Tol JL. Incidence of midportion Achilles tendinopathy in the general population. Br J Sports Med. 2011 Oct;45(13):1026-8. doi: 10.1136/bjsports-2011-090342.

  PMID: 21926076 BACKGROUND

• Malliaras P, Gravare Silbernagel K, de Vos RJ, Bourke J, Sancho I, Hanlon SL, Agergaard AS, Bahr R, Bittencourt NFN, Bordalo M, Brorsson A, Tzortziou Brown V, Cardoso T, Child S, Chimenti RL, Cowley E, D'Hooghe P, Derman W, Finnoff JT, Fu SN, Halstead J, Hamilton B, Nilsson-Helander KM, Holmich P, Houghton J, James AM, Kulig K, Lau A, Ling S, Maffulli N, Masci L, Mayes S, Mc Auliffe S, McCrum C, Morrissey D, Munteanu SE, Murphy MC, Newsham-West R, O'Neill S, Padhiar N, Papadopoulou T, Rees JD, Rio EK, Ruffino D, Scott A, Speirs S, Sun Y, Thorborg K, Trease L, Verhaar JAN, Wezenbeek E, White S, Zellers JA, Zhang S, Korakakis V, Vicenzino B. Diagnostic domains, differential diagnosis and conditions requiring further medical attention that are considered important in the assessment for Achilles tendinopathy: a Delphi consensus study. Br J Sports Med. 2025 Jun 18;59(13):891-901. doi: 10.1136/bjsports-2024-109185.

  PMID: 40240126 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 6, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2031
• Last Updated: July 6, 2026

Record last verified: 2026-06