Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain (NCT04385329) | Clinical Trial Compass
CompletedNot Applicable
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
55 participantsStarted 2016-07-04
Plain-language summary
The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.
Who can participate
Age range
18 Years – 75 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:
* Adult age (18 to 75 years) and written informed consent;
* Unilateral heel pain of four weeks or longer duration;
* Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
* Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
* Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.
Exclusion Criteria:
* No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
* No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
* No clinical signs of lumbar radiculopathy at physical examination;
* No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
* No previous fractures or surgery in the affected ankle and foot;
* No rheumatologic diseases, no plantar fibromatosis
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.
What they're measuring
1
Change in FFI-foot function index
Timeframe: FFI was administered at baseline, at two months time point and at three months time point
Trial details
NCT IDNCT04385329
SponsorFondazione IRCCS Policlinico San Matteo di Pavia