Plantar FasciitisESWNCT05090059
Myofascial Points Treatment With Focused Extracorporeal Shock Waves (ESW)
A study testing Lower limb myofascial trigger points f-ESWT in people with Plantar Fasciitis and Myofascial Trigger Point Pain, run by University of Padova at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plantar Fasciitis, Myofascial Trigger Point Pain, Foot Injury
- What is being tested?
- Lower limb myofascial trigger points f-ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2019to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
Department of Neurosciences, Physical and Rehabilitation Unit, University of Padova
Padova, 35128
About this study
Official title: Myofascial Points Treatment With Focused Extracorporeal Shock Waves (f-ESW) for Plantar Fasciitis: an Open Label Randomized Clinical Trial
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.
Read more
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.
- Being tested
- Lower limb myofascial trigger points f-ESWT
- Medical subject headings
- Fasciitis, Plantar, Myofascial Pain Syndromes, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower limb myofascial trigger points f-ESWTDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Lower limb myofascial trigger points f-ESWT group | Experimental | 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. Receives: Device: Lower limb myofascial trigger points f-ESWT |
| Plantar fascia insertion f-ESWT group | Active comparator | 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. Receives: Device: Lower limb myofascial trigger points f-ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Apr 2019
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090059
- Sponsor's protocol ID
- 61902
- Acronym
- ESW
- Status last verified
- Sep 2021
- First submitted
- 6 Sep 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myofascial Points Treatment With Focused Extracorporeal Shock Waves (f-ESW) for Plantar Fasciitis: an Open Label Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05090059
- Acronym / sponsor ID
- ESW / 61902
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower limb myofascial trigger points f-ESWT group | Experimental | Device: Lower limb myofascial trigger points f-ESWT3 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. |
| Plantar fascia insertion f-ESWT group | Active comparator | Device: Lower limb myofascial trigger points f-ESWT3 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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)
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lower limb myofascial trigger points f-ESWT3 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. | Device | Lower limb myofascial trigger points f-ESWT group, Plantar fascia insertion f-ESWT group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower limb myofascial trigger points f-ESWT in people with Plantar Fasciitis and Myofascial Trigger Point Pain, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.