Achilles Tendinopathy (AT)NCT07685509
Achilles Tendinopathy; the Effect of Shockwave Treatment
A study testing individually tailored exercises and Radial Shockwave and Individually tailored exercises in people with Achilles Tendinopathy (AT) and Achilles Tendon, run by Vastra Gotaland Region.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achilles Tendinopathy (AT), Achilles Tendon, Achilles Tendon Pain
- What is being tested?
- individually tailored exercises and Radial Shockwave and Individually tailored exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Comparison of Two Treatment Methods for Achilles Tendon Pain With a Focus on Pain, Function, Vascular Ingrowth, Immune Cell Response, and Cell Composition
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.
Read more
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.
Read the detailed description
Pain in the Achilles tendon, Achilles tendinopathy, is a common musculoskeletal condition affecting adults of all ages. The condition is characterized by localized pain and swelling in the Achilles tendon, particularly during tendon loading, functional limitations, and, in chronic cases, pathological neovascularization. Achilles tendinopathy is considered a typical overuse injury, and the diagnosis is made clinically. The incidence is reported to be 2/1000 per year, which would mean that approximately 1,400 individuals are affected each year in the Gothenburg area alone. A recent study from the United Kingdom has also shown that the typical patient is not physically active-as many clinical guidelines are designed for-but rather between 50 and 60 years old, has a high BMI, and often presents with comorbidities such as hypertension and diabetes. This highlights the need to review current clinical guidelines and evaluate the evidence for alternative treatments.
The pain is usually load-related and located either in the midportion of the Achilles tendon or at its insertion on the calcaneus. The condition is often long-lasting despite adequate treatment, and in addition to limiting physical activity, it can also affect work ability and quality of life. Non-operative treatment with heel-raise exercises and load management-appropriately dosed exercise-is the first-line standard, although long-standing or treatment-resistant cases may require adjunct therapies. Among these, extracorporeal shockwave therapy (ESWT), administered either radially (rESWT) or focally (fESWT), has emerged as a promising intervention in several studies, although it has been questioned in others. Shockwave therapy targets both pain relief and restoration of function, but its effects on pain, function, tendon morphology, and immune cell levels remain largely unexplored.
Recent systematic reviews have emphasized the need for higher-quality studies to determine whether adding shockwave therapy is beneficial for patients with Achilles tendinopathy. Evidence remains limited regarding whether shockwave therapy provides comparable pain relief for midportion versus insertional pain. Furthermore, it is unclear whether shockwave therapy must be combined with heel-raise exercises and load management or whether it can function as a standalone treatment.
Doppler ultrasound is commonly used to quantify neovascularization in the tendon. Some studies have shown that shockwave therapy induces transient increases in neovascularization that coincide with clinical improvement, while others have found no effect on neovascularization. Tendon thickness and the effect of shockwave therapy on intratendinous calcifications have also been investigated, but no consensus has been reached. Much of this research area remains unexplored due to the small number of studies and limited sample sizes.
Despite a growing evidence base suggesting that appropriately dosed exercise combined with shockwave therapy may be beneficial for tendon injuries, several areas remain under-investigated. Notably, no publications have been found on whether the micro-injuries potentially induced by shockwave therapy may cause systemic effects and thereby alter immune cell levels. Unpublished data from our research group have shown that early loading of a ruptured Achilles tendon increases circulating NK-cell levels, but whether this also applies to a painful tendon with potential tendinosis changes is unknown.
The aim of this project is to evaluate two different treatment methods for patients with Achilles tendinopathy-appropriately dosed exercise alone or appropriately dosed exercise combined with shockwave therapy-with a focus on:
Pain and muscle function
Neovascularization and calcifications in the tendon
Systemic changes in immune cell composition in the blood, with a focus on NK cells and CD8+ T cells
Hypotheses Appropriately dosed exercise combined with shockwave therapy leads to reduced pain and improved function compared with appropriately dosed exercise alone.
Appropriately dosed exercise combined with shockwave therapy reduces neovascularization and calcifications in the tendon.
Appropriately dosed exercise combined with shockwave therapy induces micro-injuries in the tendon that generate a systemic immune response (higher levels of NK cells and CD8+ T cells).
Appropriately dosed exercise combined with shockwave therapy has similar effects regardless of whether the pain is located in the midportion of the Achilles tendon or at its insertion.
Significance This project has the potential to improve the treatment of Achilles tendinopathy by identifying which patients benefit from shockwave therapy and by increasing the understanding of the biological effects of different treatment methods. The results may contribute to more individualized treatment and reduce the need for surgical interventions.
- Being tested
- individually tailored exercises and Radial Shockwave, Individually tailored exercises
- Keywords
- Achilles Tendinopathy, Shockwave, Insertional Achilles Tendinopathy, Exercise, Heel-rise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individually tailored exercises and Radial ShockwaveDevice
Shockwave: 5-6 treatments with radial shockwave, 10 bar, 2000-4000 pulses as an additional treatment to individually tailored exercises.
Individually tailored exercisesOther
Individually tailored exercises
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: individually tailored exercises and Radial Shockwave |
| Achilles Tendinopathy, exercise therapy | Active comparator | Patients with Achilles Tendinopathy receiving exercise therapy with regular follow-ups Receives: 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. Receives: 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 Receives: Other: Individually tailored exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and after 12 months after enrollment
Secondary outcomes (12)
Change in self-reported pain 3 and 6 months after treatment start
Zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: At baseline and after 3 and 6 months after enrollment
Rate of blood vessels in the Achilles tendon
Rate of blood vessels (n) (neovascularization) will be measured with Ultrasound in Doppler mode and compared with the healthy side.
Measured: At baseline and after 3, 6, and 12 month
Achilles Tendon cross-sectional area
Achilles Tendon cross-sectional area in square centimeters will be evaluated with ultrasound in the midportion of the tendon
Measured: At baseline and after 3, 6 and 12 months
Physical Activity Scale (PAS)
A patient reported outcome used for the purpose to evaluate the patients self estimated physical activity level. The scale is from 1 to 6 and the higher score, the better outcome.
Measured: At baseline and after 3,6 and 12 months
VISA-AS
A valid and reliable questionnaire developed for patients with an Achilles Tendinopathy with a purpose to evaluate patient reported outcome in terms of symptoms and function. The values can be between 0 and 100 and the higher score, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Heel-rise height during heel-rise work test
Evaluation of heel-rise height (cm) during heel-rise work test. Comparison between groups in heel-rise height Limb Symmetry Index (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Evaluation of lower leg endurance with heel-rise work (Joule)
Evaluation of lower leg endurance with heel-rise work (Joule) during heel-rise work test. Comparison between groups in heel-rise work Limb Symmetry Index (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Numbers of heel-rises during heel-rise work test
Evaluation of numbers of heel-rises during heel-rise work test. Comparison between groups in numbers of heel-rises Limb Symmetry Index (LSI) - injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Calf muscle power
Evaluation of calf muscle power in a weight training machine expressed in watt (Newton x meter /seconds). Comparison will be performed between groups and limbs in power (LSI)- injured side/healthy side *100 expressed in percent.The range in LSI is between 0-100% and the higher value, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Drop Countermovement Jump
Drop Countermovement Jump: Evaluation of vertical jumping height after jumping from a 20 cm high box. The outcome will be measured as the height the patient can perform in jump height after landing in cm. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
Measured: At baseline and after 3, 6 and 12 months
Hopping
Evaluation of series of jumps as in jumping ropes. The outcome measurement will be mean jumping height in cm and elasticity ratio in 20 jumps. Comparison between groups and limbs in jump height and elasticity ratio will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome
Measured: At baseline and after 3, 6 and 12 months
Range of motion in the ankle
Range of motion in both ankles will be measured with an inclinometer in degrees both with the knee bent and with the knee straight. Comparison between groups and limbs in jump height will be presented as Limb Symmetry Index (LSI)- injured side/healthy side *100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
Measured: At baseline and after 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Achilles Tendinopathy (AT)Studies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Göteborg University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07685509
- Sponsor's protocol ID
- 2026-01721-01
- Other IDs
- P2026-0030, 2026-01721-01
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15748297Silbernagel 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.
PubMed 16858560Jonsson 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.
PubMed 18184750Farrar 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.
PubMed 11690728Santamato 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.
PubMed 30739723Cheng 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.
PubMed 28004000Gatz 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.
PubMed 33586526Charles 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.
PubMed 37662911Feeney 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.
PubMed 35989757Paantjens 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.
PubMed 35552903Stania 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.
PubMed 38205224Pinitkwamdee 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.
PubMed 31924120Mansur 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.
PubMed 34029235Butler 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.
PubMed 39247530Abdelkader 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.
PubMed 33451253
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Treatment Methods for Achilles Tendon Pain With a Focus on Pain, Function, Vascular Ingrowth, Immune Cell Response, and Cell Composition
- ClinicalTrials.gov ID
- NCT07685509
- Acronym / sponsor ID
- 2026-01721-01
- Keywords
- Achilles Tendinopathy, Shockwave, Insertional Achilles Tendinopathy, Exercise, Heel-rise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Göteborg University
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 6 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pain in the Achilles tendon, Achilles tendinopathy, is a common musculoskeletal condition affecting adults of all ages. The condition is characterized by localized pain and swelling in the Achilles tendon, particularly during tendon loading, functional limitations, and, in chronic cases, pathological neovascularization. Achilles tendinopathy is considered a typical overuse injury, and the diagnosis is made clinically. The incidence is reported to be 2/1000 per year, which would mean that approximately 1,400 individuals are affected each year in the Gothenburg area alone. A recent study from the United Kingdom has also shown that the typical patient is not physically active-as many clinical guidelines are designed for-but rather between 50 and 60 years old, has a high BMI, and often presents with comorbidities such as hypertension and diabetes. This highlights the need to review current clinical guidelines and evaluate the evidence for alternative treatments.
The pain is usually load-related and located either in the midportion of the Achilles tendon or at its insertion on the calcaneus. The condition is often long-lasting despite adequate treatment, and in addition to limiting physical activity, it can also affect work ability and quality of life. Non-operative treatment with heel-raise exercises and load management-appropriately dosed exercise-is the first-line standard, although long-standing or treatment-resistant cases may require adjunct therapies. Among these, extracorporeal shockwave therapy (ESWT), administered either radially (rESWT) or focally (fESWT), has emerged as a promising intervention in several studies, although it has been questioned in others. Shockwave therapy targets both pain relief and restoration of function, but its effects on pain, function, tendon morphology, and immune cell levels remain largely unexplored.
Recent systematic reviews have emphasized the need for higher-quality studies to determine whether adding shockwave therapy is beneficial for patients with Achilles tendinopathy. Evidence remains limited regarding whether shockwave therapy provides comparable pain relief for midportion versus insertional pain. Furthermore, it is unclear whether shockwave therapy must be combined with heel-raise exercises and load management or whether it can function as a standalone treatment.
Doppler ultrasound is commonly used to quantify neovascularization in the tendon. Some studies have shown that shockwave therapy induces transient increases in neovascularization that coincide with clinical improvement, while others have found no effect on neovascularization. Tendon thickness and the effect of shockwave therapy on intratendinous calcifications have also been investigated, but no consensus has been reached. Much of this research area remains unexplored due to the small number of studies and limited sample sizes.
Despite a growing evidence base suggesting that appropriately dosed exercise combined with shockwave therapy may be beneficial for tendon injuries, several areas remain under-investigated. Notably, no publications have been found on whether the micro-injuries potentially induced by shockwave therapy may cause systemic effects and thereby alter immune cell levels. Unpublished data from our research group have shown that early loading of a ruptured Achilles tendon increases circulating NK-cell levels, but whether this also applies to a painful tendon with potential tendinosis changes is unknown.
The aim of this project is to evaluate two different treatment methods for patients with Achilles tendinopathy-appropriately dosed exercise alone or appropriately dosed exercise combined with shockwave therapy-with a focus on:
Pain and muscle function
Neovascularization and calcifications in the tendon
Systemic changes in immune cell composition in the blood, with a focus on NK cells and CD8+ T cells
Hypotheses Appropriately dosed exercise combined with shockwave therapy leads to reduced pain and improved function compared with appropriately dosed exercise alone.
Appropriately dosed exercise combined with shockwave therapy reduces neovascularization and calcifications in the tendon.
Appropriately dosed exercise combined with shockwave therapy induces micro-injuries in the tendon that generate a systemic immune response (higher levels of NK cells and CD8+ T cells).
Appropriately dosed exercise combined with shockwave therapy has similar effects regardless of whether the pain is located in the midportion of the Achilles tendon or at its insertion.
Significance This project has the potential to improve the treatment of Achilles tendinopathy by identifying which patients benefit from shockwave therapy and by increasing the understanding of the biological effects of different treatment methods. The results may contribute to more individualized treatment and reduce the need for surgical interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Achilles Tendinopathy, exercise therapy and additional treatment with shockwave | Experimental | Device: individually tailored exercises and Radial ShockwavePatients with Achilles Tendinopathy receiving exercise therapy with regular follow-ups and additional treatment with shockwave. |
| Achilles Tendinopathy, exercise therapy | Active comparator | Other: Individually tailored exercisesPatients with Achilles Tendinopathy receiving exercise therapy with regular follow-ups |
| Insertional Achilles Tendinopathy, exercise therapy and additional treatment with shockwave | Experimental | Device: individually tailored exercises and Radial ShockwavePatients with Insertional Achilles Tendinopathy receiving exercise therapy with regular follow-ups and additional treatment with shockwave. |
| Insertional Achilles Tendinopathy, exercise therapy | Active comparator | Other: Individually tailored exercisesPatients with Insertional Achilles Tendinopathy receiving exercise therapy with regular follow-ups |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individually tailored exercises and Radial ShockwaveShockwave: 5-6 treatments with radial shockwave, 10 bar, 2000-4000 pulses as an additional treatment to individually tailored exercises. | Device | Achilles Tendinopathy, exercise therapy and additional treatment with shockwave, Insertional Achilles Tendinopathy, exercise therapy and additional treatment with shockwave |
| Individually tailored exercisesIndividually tailored exercises | Other | Achilles Tendinopathy, exercise therapy, Insertional Achilles Tendinopathy, exercise therapy |
Primary outcome
Change in self-reported pain from baseline to 12 months after treatment start
Time frame: At baseline and after 12 months after enrollment
Zero is equivalent to no pain and 10 indicates the worst possible pain.
12 secondary outcomes
Change in self-reported pain 3 and 6 months after treatment start
Time frame: At baseline and after 3 and 6 months after enrollment
Rate of blood vessels in the Achilles tendon
Time frame: At baseline and after 3, 6, and 12 month
Achilles Tendon cross-sectional area
Time frame: At baseline and after 3, 6 and 12 months
Physical Activity Scale (PAS)
Time frame: At baseline and after 3,6 and 12 months
VISA-AS
Time frame: At baseline and after 3, 6 and 12 months
Heel-rise height during heel-rise work test
Time frame: At baseline and after 3, 6 and 12 months
Evaluation of lower leg endurance with heel-rise work (Joule)
Time frame: At baseline and after 3, 6 and 12 months
Numbers of heel-rises during heel-rise work test
Time frame: At baseline and after 3, 6 and 12 months
Calf muscle power
Time frame: At baseline and after 3, 6 and 12 months
Drop Countermovement Jump
Time frame: At baseline and after 3, 6 and 12 months
Hopping
Time frame: At baseline and after 3, 6 and 12 months
Range of motion in the ankle
Time frame: At baseline and after 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Background: PubMed 15748297Silbernagel 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.
- Background: PubMed 16858560Silbernagel 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.
- Background: PubMed 18184750Jonsson 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.
- Background: PubMed 11690728Farrar 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.
- Background: PubMed 30739723Santamato 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.
- Background: PubMed 28004000Cheng 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.
- Background: PubMed 33586526Gatz 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.
- Background: PubMed 37662911Charles 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.
- Background: PubMed 35989757Feeney 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.
- Background: PubMed 35552903Paantjens 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.
- Background: PubMed 38205224Stania 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.
- Background: PubMed 31924120Pinitkwamdee 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing individually tailored exercises and Radial Shockwave and Individually tailored exercises in people with Achilles Tendinopathy (AT) and Achilles Tendon, run by Vastra Gotaland Region.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported pain from baseline to 12 months after treatment start (time frame: At baseline and after 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07685509, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.