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Efficacy of a Locoregional Anesthesia Technique During Shock Wave Therapy

NCT03918434 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 21

Last updated 2021-10-08

No results posted yet for this study

Summary

Plantar fasciitis and the chronic Achilles tendinopathy are the most common causes of heel pain. The term "plantar fasciitis" implies an inflammatory condition by the suffix "itis". However, various lines of evidence indicate that this disorder is better classified as "fasciosis" or "fasciopathy", as heel pain associated with degenerative changes in the fascia and atrophy of the abductor minimi muscle. High energy shock wave therapy (HESWT) has been proposed as a potential method of treating patients with chronic disease without the need to stop weightbearing. Often a crucial complication of HESWT is the appearance of pain with the subsequent interruption of the procedure. The consequences are a reduced patient compliance, need of a deep sedation and more sessions for the treatment.

Frequently, topic anesthesia (TA) (as EMLA) is applied during the therapy to decrease the pain HESWT-induced and enable sham treatment. Multiple publications focused on the evaluation of a clinically relevant effect of shock wave application on plantar heel pain, either of HESWT, applied in a single session with local or regional anesthesia or of low energy HESWT, applied repetitively without local anesthesia.

Rompe JD and colleagues have demonstrated that the therapeutic success rate of HESWT with TA is significantly smaller than without TA even after 3 months. Probably, the use of anesthetic topically applied can reduce the efficacy of HESWT for increased impedance. To date, many patients interrupted the HESWT for moderate-severe pain. Consequently, this therapy, which generally is administered in three sessions, required a prolongation of procedure up to six sessions.The clinical application of Posterior Tibial nerve block (already widely used in operating room) during HESWT applied in Orthopedic Day Hospital could offer the possibility to minimize the patient discomfort and to give the therapeutic doses just in few HESWT sessions, reducing the hospital access of outpatients for the treatments and the costs related to prolonged treatment caused by pain. Furthermore, this anesthetic approach could make patients tolerate majorated doses of HESWT in few sessions, with high effectiveness of procedure after several months.

Conditions

  • Achilles Tendinopathy
  • Plantar Fascitis

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2019-11-30
Completion
2019-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03918434 on ClinicalTrials.gov