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Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW) (ESW)

Primary Purpose

Plantar Fasciitis, Myofascial Trigger Point Pain, Foot Injury

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Lower limb myofascial trigger points f-ESWT
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurosciences, Physical and Rehabilitation Unit, University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lower limb myofascial trigger points f-ESWT group

Plantar fascia insertion f-ESWT group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in 17-Italian Foot Function Index (17-iFFI)
Self-administered questionnaire. It consists in 17 items divided into 3 subscales: pain (5 items), disability (9 items), and limitation of activity (3 items). The items are rated on a Visual Analogue Scale (VAS), from 0 to 10. A score is calculated for every subgroup of items, and then the final score is calculated by adding the subscale's scores and dividing the result by 170. The final percentage score is between 0% (best outcome) and 100% (worst outcome).
Change in Foot and Ankle Outcome Scale (FAOS)
Self-administered questionnaire. It consists of 42 items divided in 5 subscales: pain (9 items), other symptoms (7 items), function in activities of daily living (17 items), function in sports and recreation (5 items), and foot-and-ankle related quality of life (4 items). The questions are made to be answered with qualitative terms (None, Mild, Moderate, Severe, Extreme) or temporal terms (Never, Rarely, Sometimes, Often, Always) corresponding to a numeric value, from 0 to 4. The score for each subdomain as well as the total FAOS is then calculated and normalized to a 0-100 scale, where 0% is the worst outcome and 100% the best outcome. Then, a final, global percentage score, from 0% (worst outcome) to 100% (best outcome), is given.

Secondary Outcome Measures

Full Information

First Posted
September 6, 2021
Last Updated
October 10, 2021
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05090059
Brief Title
Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)
Acronym
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis, Myofascial Trigger Point Pain, Foot Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lower limb myofascial trigger points f-ESWT group
Arm Type
Experimental
Arm 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.
Arm Title
Plantar fascia insertion f-ESWT group
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Lower limb myofascial trigger points f-ESWT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in 17-Italian Foot Function Index (17-iFFI)
Description
Self-administered questionnaire. It consists in 17 items divided into 3 subscales: pain (5 items), disability (9 items), and limitation of activity (3 items). The items are rated on a Visual Analogue Scale (VAS), from 0 to 10. A score is calculated for every subgroup of items, and then the final score is calculated by adding the subscale's scores and dividing the result by 170. The final percentage score is between 0% (best outcome) and 100% (worst outcome).
Time Frame
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)
Title
Change in Foot and Ankle Outcome Scale (FAOS)
Description
Self-administered questionnaire. It consists of 42 items divided in 5 subscales: pain (9 items), other symptoms (7 items), function in activities of daily living (17 items), function in sports and recreation (5 items), and foot-and-ankle related quality of life (4 items). The questions are made to be answered with qualitative terms (None, Mild, Moderate, Severe, Extreme) or temporal terms (Never, Rarely, Sometimes, Often, Always) corresponding to a numeric value, from 0 to 4. The score for each subdomain as well as the total FAOS is then calculated and normalized to a 0-100 scale, where 0% is the worst outcome and 100% the best outcome. Then, a final, global percentage score, from 0% (worst outcome) to 100% (best outcome), is given.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Neurosciences, Physical and Rehabilitation Unit, University of Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)

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