Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave Therapy in the Insertional Achilles … (NCT02757664) | Clinical Trial Compass
CompletedNot Applicable
Clinical Trial to Evaluate the Adjuvant Effect of Shock Wave Therapy in the Insertional Achilles Tendinopathy
Brazil119 participantsStarted 2017-02-01
Plain-language 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).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contraindic…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.