Treatment for heel pain using neuromodulation techniques
Neuromodulation of the Posterior Tibial Nerve in the Heel Spur (Epin Calcanei): Randomized Controlled Trial
This study is testing two different treatments for heel pain to see which one helps people with heel spurs feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06558552 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of transcutaneous pulsed radiofrequency and extracorporeal shock wave therapy in treating patients diagnosed with heel spurs. A total of 100 patients aged 18 to 65 will be recruited from the Algology and Physical Medicine and Rehabilitation departments at Kanuni Sultan Süleyman Training and Research Hospital. Participants will be randomly assigned to receive one of the two treatment modalities, with their health monitored throughout the process. The study will take place between May 2024 and August 2024, focusing on improving pain management and quality of life for those suffering from chronic heel pain.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 who have been diagnosed with heel spurs through clinical and radiological assessments.
Not a fit: Patients who have undergone recent interventional procedures for heel spurs or have certain medical conditions, such as severe obesity or advanced heart failure, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce heel pain and improve the quality of life for patients with heel spurs.
How similar studies have performed: While there is ongoing research in the field of neuromodulation for pain management, the specific combination of treatments in this study is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-65, * Patients diagnosed with calcaneus spur and epin calcaneus in radiological imaging with anamnesis, clinical and physical examination * Patients who signed the voluntary consent form Exclusion Criteria: * Patients who have undergone interventional procedures for heel spurs in the last 6 months, * Morbidly obese patients (BMI\>35 kg/m2), * Patients with advanced decompensated heart failure and pacemakers, * Patients with known transcutaneous pad allergy, patients with skin infection in the area where ESWT was performed or pads were attached, * Patients with metal implants, * Patients with circulatory disorders and lesions, * Patients who cannot communicate and cannot be positioned, * Patients with bleeding disorders, patients with severe psychosis and progressive neurological deficits and muscle diseases, * and pregnant women.
Where this trial is running
Istanbul
- Kanuni Sultan Süleyman Training and Research Hospital — Istanbul, Turkey (Recruiting)
Study contacts
- Principal investigator: halil ibrahim altun, specialist — Kanuni Sultan Süleyman Training and Research Hospital
- Study coordinator: halil ibrahim altun, specialist
- Email: halilibrahim_altun@yahoo.com
- Phone: +905072774773
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.