Clinical trial NCT05090059: Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)
Official title: Myofascial Points Treatment With Focused Extracorporeal Shock Waves (f-ESW) for Plantar Fasciitis: an Open Label Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fasciitis
Myofascial Trigger Point Pain
Foot Injury
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 17-Italian Foot Function Index (17-iFFI)
timeFrame: T1 (baseline - immediately before the first session); T2 (1 week - immediately before the second session); T3 (2 weeks - immediately before the third session); T4 (1 month follow-up); T5 (4 months follow-up)
measure: Change in Foot and Ankle Outcome Scale (FAOS)
timeFrame: T1 (baseline - immediately before the first session); T2 (1 week - immediately before the second session); T3 (2 weeks - immediately before the third session); T4 (1 month follow-up); T5 (4 months follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Department of Neurosciences, Physical and Rehabilitation Unit, University of Padova
Study officials:
References: