Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)

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.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Foot Injuries Foot Injury Leg Injuries Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Myofascial Trigger Point Pain Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Padova, 35128, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lower limb myofascial trigger points f-ESWT

Device

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 outcomes

Change in 17-Italian Foot Function Index (17-iFFI)

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)

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)

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)

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.

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

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

Acronym: ESW

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 22, 2021
Registry last updated: Oct 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed