| Registry | NCT07233395 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 60 (Estimated) |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital (Other) |
| Conditions | Plantar Fasciitis |
| Interventions | Dextrose Prolotherapy, Extracorporeal Shock Wave Therapy (ESWT) (Procedure, device) |
| Dates | start 2025-11-15 (estimated), primary completion 2026-01-15 (estimated), completion 2026-03-15 (estimated), first posted 2025-11-18, last updated 2025-11-18 |
Related Papers Related Patents Related Grants Related Experts
All trials for Plantar Fasciitis All trials of Dextrose Prolotherapy All trials of Extracorporeal Shock Wave Therapy (ESWT)
Plantar fasciitis is a degeneration of the plantar aponeurosis and is the most common cause of heel pain (11-15%). Although seen in both sexes, plantar fasciitis is more common in women, usually unilateral and bilateral in 30% of cases . The most widely accepted view regarding the formation of plantar fasciitis is that it is a degenerative process caused by myxoid degeneration, microtears, collagen necrosis, and angiofibroblastic hyperplasia, resulting from repetitive microtrauma to the plantar fascia, particularly at the calcaneal insertion site. It is not inflammatory . The purpose of this study was to compare the effectiveness of prolotherapy, a regenerative treatment, and ESWT in the treatment of plantar fasciitis.
Plantar fasciitis is known as the most common cause of heel pain in adults. While its incidence increases between the ages of 40 and 60, it is more common in runners, those who work in positions requiring prolonged standing, overweight individuals, and those with certain biomechanical foot problems. Diagnosis of plantar fasciitis can be easily made through history and physical examination. Conservative methods are the first line of treatment. Local injections and ESWT are used in patients who fail to improve despite conservative treatment. ESWT and Prolotherapy are treatment methods that induce regeneration by creating a controlled inflammation. This prospective study aims to compare the effectiveness of ESWT and Prolotherapy, which have similar mechanisms of action, in the treatment of plantar fasciitis and to identify the more effective method.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Dextrose Prolotherapy | Experimental | Procedure: Dextrose Prolotherapy | Participants in this group will receive dextrose prolotherapy twice, at two-week intervals. A 5 mL syringe will be prepared with 2.5 mL of 30% dextrose, 2 mL of isotonic saline, and 0.5 mL of 2% lidocaine (final 15% dextrose solution). Injections will be administered into seven points around the plantar fascia origin and insertion under aseptic conditions. |
| Extracorporeal Shock Wave Therapy (ESWT) | Active comparator | Device: Extracorporeal Shock Wave Therapy (ESWT) | Participants in this group will receive extracorporeal shock wave therapy (ESWT) twice per week for a total of four sessions. The treatment will be applied to the plantar fascia insertion using a standard clinical ESWT device following manufacturer guidelines. |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: * Diagnosis of plantar fasciitis Ages 18 to 75 years Both male and female participants Heel pain localized to the medial calcaneal tubercle for more than 3 months Morning first-step pain and pain increasing with daily loading Willingness to participate and provide written informed consent Patients presenting to Kanuni Sultan Süleyman Training and Research Hospital Exclusion Criteria: Cardiac pacemaker Type 1 or Type 2 diabetes mellitus History of inflammatory rheumatic disease Bleeding disorders Use of anticoagulant medications other than aspirin Allergy to dextrose Previous foot or ankle surgery Peripheral neuropathy S1 radiculopathy in the same extremity Local corticosteroid injection to the plantar fascia within the last 3 months ESWT applied to the plantar fascia within the last 3 months Physical therapy applied to the foot/ankle in the last 3 months Cognitive dysfunction Active infection at the planned injection site \-