Achilles Tendinopathy; the Effect of Shockwave Treatment

ConditionsAchilles Tendinopathy (AT)Achilles Tendon Achilles Tendon Pain

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
Individually tailored exercises
Other intervention
Individually tailored exercises

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: Achilles Tendinopathy, exercise therapy and additional treatment with shockwaveExperimental treatment 1 intervention

Group B: Achilles Tendinopathy, exercise therapyActive comparator 1 intervention

Group C: Insertional Achilles Tendinopathy, exercise therapy and additional treatment with shockwaveExperimental treatment 1 intervention

Group D: Insertional Achilles Tendinopathy, exercise therapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

At baseline and after 12 months after enrollment

Secondary outcomes

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.

Time frame

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.

Time frame

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

Time frame

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.

Time frame

At baseline and after 3,6 and 12 months

Other outcomes

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

10 ml blood will be collected at two times from a cohort of the population. Flow cytometry and antibody staining will be used for immune profiling.

Time frame

At baseline and after 4-6 weeks

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vastra Gotaland Region

Lead sponsor

Göteborg University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: