TendinopathyNCT04385329
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
A study testing Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points and Shock wave therapy on plantar fascia only in people with Tendinopathy, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
Trial summary
The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendinopathy
- What is being tested?
- Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points and Shock wave therapy on plantar fascia only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 4 Jul 2016to 3 Nov 2018
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult age (18 to 75 years) and written informed consent;
- Unilateral heel pain of four weeks or longer duration;
- Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
- Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
- Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.
Who cannot join
- No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
- No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
- No clinical signs of lumbar radiculopathy at physical examination;
- No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
- No previous fractures or surgery in the affected ankle and foot;
- No rheumatologic diseases, no plantar fibromatosis
About this study
Official title: Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.
- Conditions
- Tendinopathy
- Being tested
- Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points, Shock wave therapy on plantar fascia only
- Keywords
- Myofascial pain syndrome
- Medical subject headings
- Tendinopathy, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger pointsOther
Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.
Shock wave therapy on plantar fascia onlyOther
Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group:shock waves extended to gastrocnemius TrP | Experimental | Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points. Receives: Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points |
| Control group: shock waves not extended to gastrocnemius TrP | Active comparator | A standard focused shock wave therapy exclusively targeted at the plantar fascia Receives: Other: Shock wave therapy on plantar fascia only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FFI-foot function index
Foot Function Index is self-administered questionnaire designed to measure foot performances in relation to symptoms. Foot Function Index is structured in two sections of nine items each, investigating foot pain (FFI-A) and function (FFI-B) respectively. The total score of each section ranges from zero (no pain/no functional limitation) to 100 (intolerable pain/complete inability). The two scores were separately analysed.
Measured: FFI was administered at baseline, at two months time point and at three months time point
Secondary outcomes (1)
Change in PPT-pressure pain threshold
Pressure pain threshold (PPT) of the gastrocnemius-soleus trigger points was assessed by means of a digital hand-held algometer (see procedures for details). PPT is the minimal force that induces pain and its measurement is useful to quantitatively evaluate the effect of a treatment on trigger points
Measured: PPT was recorded at baseline, at two months time point and at three months time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start4 Jul 2016
- Primary completion4 Jul 2018
- Study completion3 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TendinopathyStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore Carlis, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385329
- Sponsor's protocol ID
- 20160017179
- Status last verified
- May 2020
- First submitted
- 5 May 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04385329
- Acronym / sponsor ID
- 20160017179
- Conditions
- Tendinopathy
- Keywords
- Myofascial pain syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 4 Jul 2016 (actual)
- Primary completion
- 4 Jul 2018 (actual)
- Study completion
- 3 Nov 2018 (actual)
- First posted
- 12 May 2020 (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.
The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group:shock waves extended to gastrocnemius TrP | Experimental | Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger pointsFocused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points. |
| Control group: shock waves not extended to gastrocnemius TrP | Active comparator | Other: Shock wave therapy on plantar fascia onlyA standard focused shock wave therapy exclusively targeted at the plantar fascia |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult age (18 to 75 years) and written informed consent;
- Unilateral heel pain of four weeks or longer duration;
- Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum;
- Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details);
- Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description.
Key exclusion criteria (6 listed)
- No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses);
- No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area);
- No clinical signs of lumbar radiculopathy at physical examination;
- No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings;
- No previous fractures or surgery in the affected ankle and foot;
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 |
|---|---|---|
| Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger pointsEnrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique. | Other | Experimental group:shock waves extended to gastrocnemius TrP |
| Shock wave therapy on plantar fascia onlyEnrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique. | Other | Control group: shock waves not extended to gastrocnemius TrP |
Primary outcome
Change in FFI-foot function index
Time frame: FFI was administered at baseline, at two months time point and at three months time point
Foot Function Index is self-administered questionnaire designed to measure foot performances in relation to symptoms. Foot Function Index is structured in two sections of nine items each, investigating foot pain (FFI-A) and function (FFI-B) respectively. The total score of each section ranges from zero (no pain/no functional limitation) to 100 (intolerable pain/complete inability). The two scores were separately analysed.
1 secondary outcome
Change in PPT-pressure pain threshold
Time frame: PPT was recorded at baseline, at two months time point and at three months time point
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 12 May 2020.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points and Shock wave therapy on plantar fascia only in people with Tendinopathy, run by Fondazione IRCCS Policlinico San Matteo di Pavia.
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 5 inclusion and 6 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 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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 FFI-foot function index (time frame: FFI was administered at baseline, at two months time point and at three months time point). 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 12 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.