Fasciitis, PlantarNCT04664712
Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement
A study testing Tendisulfur Pro and Focused shock wave in people with Fasciitis, Plantar, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- Tendisulfur Pro and Focused shock wave
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 11 Sep 2019to 20 Nov 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;
Who cannot join
- History of previous fractures or ankle and heel surgery;
- Recurrence of previous local painful episodes;
- Lesion of the plantar fascia on US examination;
- Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
- Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.
Trial locations and contacts
1 site in 1 country.
Italy1 site
AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia
Bari, 70124
About this study
Official title: Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement in the Treatment of Plantar Fasciitis: a Prospective Randomized Study
Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.
Read the detailed description
A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).
- Conditions
- Fasciitis, Plantar
- Being tested
- Tendisulfur Pro, Focused shock wave
- Keywords
- focused shock waves, tendinitis, natriuretics
- Medical subject headings
- Fasciitis, Plantar, Tendinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendisulfur ProDietary supplement
Dietary supplement based on Methylsulfonylmethane (2.5 g), hydrolyzed collagen (1 g), L-arginine (1 g), L-lysine (500 mg), Vitamin C (500 mg), Bromelain (200 mg), Chondroitin sulfate (150 mg), Glucosamine (150 mg) [17, 18], dry extracts of turmeric (100 mg), Boswellia (100 mg) and Myrrh (50 mg)
Focused shock waveDevice
We delivered 2000 shots per session using a low/medium energy level (range between 0.01 and 0.175 milliJoule/mm2) depending on the patient's tolerance during treatment with a frequency of 4 Hz.
| Study group | Role | What they receive |
|---|---|---|
| shock wave | Active comparator | Not described Receives: Device: Focused shock wave |
| shock wave and tendon supplement | Active comparator | Not described Receives: Dietary Supplement: Tendisulfur Pro; Device: Focused shock wave |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analogue Score (VAS)
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain) and 10 (worst imaginable pain).
Measured: T0 (recruitment); T1 (three months)
Change in Visual Analogue Score (VAS)
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)
Measured: T1 (three months); T2 (six months)
Secondary outcomes (4)
Change in American Foot & Ankle Score (AOFAS)
The scores ranging between 100 (no disability) and 0 (maximum disability)
Measured: T0 (recruitment); T2 (six months)
Change in Foot Function Index (FFI)
The scores ranging between 100 (no disability) and 0 (maximum disability).
Measured: T0 (recruitment); T2 (six months)
Roles & Maudsley (R&M)
Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).
Measured: T1 (three months)
Roles & Maudsley (R&M)
Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).
Measured: T2 (six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start11 Sep 2019
- Primary completion1 May 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fasciitis, PlantarStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Biagio Moretti, Prof, Principal investigator, University of Bari Aldo Moro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664712
- Sponsor's protocol ID
- ESWT-TP
- Status last verified
- Nov 2020
- First submitted
- 25 Nov 2020
- Last updated
- 11 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement in the Treatment of Plantar Fasciitis: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04664712
- Acronym / sponsor ID
- ESWT-TP
- Conditions
- Fasciitis, Plantar
- Keywords
- focused shock waves, tendinitis, natriuretics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 11 Sep 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 11 Dec 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.
Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.
Detailed description
A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| shock wave | Active comparator | Device: Focused shock wave |
| shock wave and tendon supplement | Active comparator | Dietary Supplement: Tendisulfur Pro, Device: Focused shock wave |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;
Key exclusion criteria (5 listed)
- History of previous fractures or ankle and heel surgery;
- Recurrence of previous local painful episodes;
- Lesion of the plantar fascia on US examination;
- Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
- Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.
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 |
|---|---|---|
| Tendisulfur ProDietary supplement based on Methylsulfonylmethane (2.5 g), hydrolyzed collagen (1 g), L-arginine (1 g), L-lysine (500 mg), Vitamin C (500 mg), Bromelain (200 mg), Chondroitin sulfate (150 mg), Glucosamine (150 mg) [17, 18], dry extracts of turmeric (100 mg), Boswellia (100 mg) and Myrrh (50 mg) | Dietary supplement | shock wave and tendon supplement |
| Focused shock waveWe delivered 2000 shots per session using a low/medium energy level (range between 0.01 and 0.175 milliJoule/mm2) depending on the patient's tolerance during treatment with a frequency of 4 Hz. | Device | shock wave, shock wave and tendon supplement |
Primary outcome
Change in Visual Analogue Score (VAS)
Time frame: T0 (recruitment); T1 (three months)
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain) and 10 (worst imaginable pain).
Change in Visual Analogue Score (VAS)
Time frame: T1 (three months); T2 (six months)
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)
4 secondary outcomes
Change in American Foot & Ankle Score (AOFAS)
Time frame: T0 (recruitment); T2 (six months)
Change in Foot Function Index (FFI)
Time frame: T0 (recruitment); T2 (six months)
Roles & Maudsley (R&M)
Time frame: T1 (three months)
Roles & Maudsley (R&M)
Time frame: T2 (six months)
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 11 Dec 2020.
- Individual participant dataSharing planned: No. No sharing
Related trials for Fasciitis, Plantar
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Hip Muscle Strengthening and Calf Myofascial Release in Females With Chronic Plantar Fasciitis
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F-18 Sodium Fluoride PET/CT-Guided Pain Palliation in Chronic Plantar Fasciitis: A Comparative Study of ¹⁷⁷Lutetium-Corticosteroid-Local Anaesthetic Injection vs Corticosteroid-Local Anaesthetic Injection
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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.
Biagio Moretti, Prof principal investigator
University of Bari Aldo Moro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendisulfur Pro and Focused shock wave in people with Fasciitis, Plantar, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari 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 1 inclusion and 5 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 11 Dec 2020. 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 Visual Analogue Score (VAS) (time frame: T0 (recruitment); T1 (three months)). 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 11 Dec 2020.