Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)
NCT ID: NCT05090059
Last Updated: 2021-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-04-01
2020-02-28
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lower limb myofascial trigger points f-ESWT group
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.
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.
Plantar fascia insertion f-ESWT group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 infections,
* neurological deficits of the lower limbs,
* diagnosis or suspect of fibromyalgia,
* local steroid injection within the previous 3 months,
* diabetes mellitus,
* vascular diseases
18 Years
ALL
No
Sponsors
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University of Padova
OTHER
Responsible Party
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Locations
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Department of Neurosciences, Physical and Rehabilitation Unit, University of Padova
Padua, , Italy
Countries
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Other Identifiers
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61902
Identifier Type: -
Identifier Source: org_study_id