Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)

University of Padova

Status: Completed

Conditions: Plantar Fasciitis; Myofascial Trigger Point Pain; Foot Injury

Treatments: Device: Lower limb myofascial trigger points f-ESWT

Study type: Interventional

Funder types: Other

Identifiers

NCT05090059

61902

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age,
• the presence of heel pain ≥ 3 months duration unresponsive to first-choice conservative treatments (non-steroidal anti-inflammatory and/or other analgesic drugs, exercise program, insoles),
• specialist diagnosis of plantar fasciitis confirmed with clinical examination,
• pain intensity ≥ 5 at the Visual Analog Scale (VAS)

Exclusion criteria

• previous ankle/foot fracture or surgery,
• previous ankle/foot infections,
• neurological deficits of the lower limbs,
• diagnosis or suspect of fibromyalgia,
• local steroid injection within the previous 3 months,
• diabetes mellitus,
• vascular diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Lower limb myofascial trigger points f-ESWT group

Experimental group

Description:

3 total sessions, one per week, 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 or 4 myofascial points (identified based on Fascial Manipulation principles), 1500 shocks per point.

Treatment:

Device: Lower limb myofascial trigger points f-ESWT

Plantar fascia insertion f-ESWT group

Active Comparator group

Description:

3 total sessions, one per week, of focused extracorporeal shockwave treatment, with a frequency of 5 Hz, an energy flux density of 0.32 mJ(millijoule)/mm2, for a total of 2000 shocks administered on the area of the painful heel on the medial calcaneal tubercle.

Treatment:

Device: Lower limb myofascial trigger points f-ESWT