NCT05090059

Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)

Myofascial Points Treatment With Focused Extracorporeal Shock Waves (f-ESW) for Plantar Fasciitis: an Open Label Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: University of Padova · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Plantar fasciitis (PF) is a common cause of heel pain. Among the several conservative treatment options, Extracorporeal Shock Wave Therapy (ESWT) is considered the standard treatment. Recent studies suggest that PF may be sustained by a myofascial impairment proximal to the pain area with a biomechanical disequilibrium of the entire lower limb and pelvis. Therefore, by combining the concepts of Fascial Manipulation and ESWT, the purpose of this open label randomized controlled clinical trial is to evaluate the effectiveness of the ESWT on myofascial trigger points of lower limb in a sample of subjects with PF. Patients with PF were randomly assigned to an Experimental treatment Group (EG), treated with focused ESWT on myofascial points, and a Control Group (CG), treated with the focused ESWT traditional approach on the medial calcaneal tubercle. Outcome measures included the Foot and Ankle Outcome Score (FAOS) and the Italian Foot Functional Index (17-iFFI). The assessment was made before the first session(baseline-T1), immediately before the second session (T2), immediately before the third session (T3), at 1month (T4) and 4 months' follow-up (T5). Thirty patients who satisfied inclusion and exclusion criteria were enrolled.

Conditions

• Plantar Fasciitis
• Myofascial Trigger Point Pain
• Foot Injury

Interventions

Type	Name	Description
DEVICE	Lower limb myofascial trigger points f-ESWT	3 weekly sessions of focused Extracorporeal Shockwave treatment with a frequency of 5 Hz, an energy flux density of 0.05-0.167 mJ(millijoule)/mm2, administered on 3-4 myofascial lower limb trigger points (identified according to the approach of Fascial Manipulation), 1500 shocks per point.

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-02-28
• Completion: 2020-02-28
• First posted: 2021-10-22
• Last updated: 2021-10-22

Locations

1 site across 1 country: Italy