Fasciitis, PlantarTHEAL-FNCT05925777
Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
A study testing THEAL (Mectronic, Bergamo) in people with Fasciitis, Plantar, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial summary
Standard treatments of plantar fasciitis include stretching exercises of the posterior muscle chain and plantar fascia, taking anti-inflammatories, cortisone infiltration or biostimulation with physical therapies (low energy laser therapy, shock waves, ultrasound therapy, etc.). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- THEAL (Mectronic, Bergamo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Aug 2023to 1 May 2025
- 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
- history of heel pain for at least 3 months prior to enrollment,
- Pain on palpation of the medial calcaneal tubercle or proximal plantar fascia,
- plantar fascia thickness of 4.0 mm or greater.
Who cannot join
- age below 18 years of age
- history of systemic disease
- pregnancy
- Previous surgery on the lower limbs
- diagnosis of fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel joint syndrome
- body mass index (BMI) greater than 35 kg/m2
Show all 17Show fewer
- wounds, infections in the treatment area
- altered sensation in the treatment area
- skin pigmentation alterations in the area to be treated (tattoo, dyschromia)
- metal implants in the treatment area
- History of oral or injected corticosteroid therapy within the past six weeks
- Diagnosis of neurological heel pain (radiculopathy)
- diagnosis of systemic inflammatory arthritis (rheumatoid arthritis, etc.)
- other acute pathologies (febrile fever, cold, etc.) requiring treatment
- other painful conditions requiring painkillers (toothache, back pain, etc.)
- neoplasms
- cardiac pacemaker or other device.
Trial locations and contacts
1 site in 1 country.
About this study
Standard treatments of plantar fasciitis include stretching exercises of the posterior muscle chain and plantar fascia, taking anti-inflammatories, cortisone infiltration or biostimulation with physical therapies (low energy laser therapy, shock waves, ultrasound therapy, etc.). In non-responsive forms to conservative treatments, surgical treatment can be undertaken.
Laser therapy is indicated for plantar fasciitis, in particular for its biological anti-inflammatory, anti-edema and reparative effects on the plantar fascia; to date, the potential effects also on the underlying bone edema component, when present, which aggravates and self-maintains the ongoing pathology are not known.
Read the detailed description
Plantar fasciitis is one of the most common causes of heel pain; the pain is more intense in the morning, tends to decrease during the day with movement, to flare up after sitting for a long time. It presents itself as inflammation and contextual degeneration of the insertion of the fascia that covers the muscles present at the level of the sole of the foot, with progressive evolution and possible calcification of the insertion. The incidence is between 9 and 20% of the population, with a higher incidence in middle-aged obese women and in young male runners. The diagnosis makes use of radiography, to verify any local deformities or the presence of the subcalcaneal spur, and ultrasound, to investigate the integrity of the fascia and its thickening. MRI images are useful for better studying the heel bone and plantar fascia, especially for discerning other various causes of heel pain, including stress fractures, tarsal tunnel syndrome, and Achilles tendinopathy. Signal changes with bone edema are sometimes found in association with plantar fasciitis and may be indicative of or represent the result of avulsive trauma, stress, intraspongious fractures or a combination of these situations. These MRI images are similar to those described in the elbow in some patients with epicondylitis, where overuse can cause increased bone edema on T2-weights. Previous studies have shown the presence of bone edema at the level of the heel on MRI in 35% of patients with plantar fasciitis. Plantar fascia evaluation with a dedicated magnetic resonance scanner in weight-bearing position: our experience in patients with plantar fasciitis and in healthy volunteers. Maier et al demonstrated that the presence of calcaneal bone edema is a highly predictive factor for improved response to shock wave treatment. Often the finding of a thickening of the fascia and the signal changes of the soft tissues do not correlate with the clinical response, while the presence of bone edema is highly predictive (positive predictive value 0.94, sensitivity 0.89, specificity 0.8).
- Conditions
- Fasciitis, Plantar
- Being tested
- THEAL (Mectronic, Bergamo)
- Keywords
- laser, foot, ankle, pain
- Medical subject headings
- Fasciitis, Plantar, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THEAL (Mectronic, Bergamo)Device
Also called laser
laser therapy high intensity
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The protocol provides for the administration of 10 polymodal high energy laser therapy sessions, to be carried out every other day. The THEAL device (Mectronic, Bergamo) allows to deliver 4 wavelengths (650 nm, 810 nm, 980 nm and 1064 nm), with continuous and pulsed mode, with power up to 20 W.
Patients will perform stretching exercise like those of the control group. Receives: Device: THEAL (Mectronic, Bergamo) |
| Control group | No intervention | Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks. 1. Hamstring and ankle plantar flexor stretch (straight leg raise in supine position) 2. self-stretching of the surae muscles: the patient bends forward in a standing position with the affected foot farthest from the wall, keeping the heel on the floor; 3. the soleus muscle is exercised with the knee flexed and the gastrocnemius muscle with the knee extended 4. Plantar fascia self-stretch: In a seated position, the patient crosses the affected foot over the contralateral thigh and passively extends the metatarsophalangeal joints . In the first session, the volunteers will be trained on how to perform the exercises correctly and will be monitored once a week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: change between baseline to 2 months
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: change between baseline to 6 months
Secondary outcomes (4)
functional recovery
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
Measured: change between baseline to 2 months
functional recovery
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
Measured: change between baseline to 6 months
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Measured: change between baseline to 2 months
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Measured: change between baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Aug 2023
- Primary completion1 Jan 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Model description
- randomized prospective
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925777
- Sponsor's protocol ID
- THEAL-fasc
- Acronym
- THEAL-F
- Status last verified
- May 2025
- First submitted
- 13 Jun 2023
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
PubMed 12851352
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
- ClinicalTrials.gov ID
- NCT05925777
- Acronym / sponsor ID
- THEAL-F / THEAL-fasc
- Conditions
- Fasciitis, Plantar
- Keywords
- laser, foot, ankle, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 29 Jun 2023 (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.
Standard treatments of plantar fasciitis include stretching exercises of the posterior muscle chain and plantar fascia, taking anti-inflammatories, cortisone infiltration or biostimulation with physical therapies (low energy laser therapy, shock waves, ultrasound therapy, etc.). In non-responsive forms to conservative treatments, surgical treatment can be undertaken.
Laser therapy is indicated for plantar fasciitis, in particular for its biological anti-inflammatory, anti-edema and reparative effects on the plantar fascia; to date, the potential effects also on the underlying bone edema component, when present, which aggravates and self-maintains the ongoing pathology are not known.
Detailed description
Plantar fasciitis is one of the most common causes of heel pain; the pain is more intense in the morning, tends to decrease during the day with movement, to flare up after sitting for a long time. It presents itself as inflammation and contextual degeneration of the insertion of the fascia that covers the muscles present at the level of the sole of the foot, with progressive evolution and possible calcification of the insertion. The incidence is between 9 and 20% of the population, with a higher incidence in middle-aged obese women and in young male runners. The diagnosis makes use of radiography, to verify any local deformities or the presence of the subcalcaneal spur, and ultrasound, to investigate the integrity of the fascia and its thickening. MRI images are useful for better studying the heel bone and plantar fascia, especially for discerning other various causes of heel pain, including stress fractures, tarsal tunnel syndrome, and Achilles tendinopathy. Signal changes with bone edema are sometimes found in association with plantar fasciitis and may be indicative of or represent the result of avulsive trauma, stress, intraspongious fractures or a combination of these situations. These MRI images are similar to those described in the elbow in some patients with epicondylitis, where overuse can cause increased bone edema on T2-weights. Previous studies have shown the presence of bone edema at the level of the heel on MRI in 35% of patients with plantar fasciitis. Plantar fascia evaluation with a dedicated magnetic resonance scanner in weight-bearing position: our experience in patients with plantar fasciitis and in healthy volunteers. Maier et al demonstrated that the presence of calcaneal bone edema is a highly predictive factor for improved response to shock wave treatment. Often the finding of a thickening of the fascia and the signal changes of the soft tissues do not correlate with the clinical response, while the presence of bone edema is highly predictive (positive predictive value 0.94, sensitivity 0.89, specificity 0.8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized prospective
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: THEAL (Mectronic, Bergamo)The protocol provides for the administration of 10 polymodal high energy laser therapy sessions, to be carried out every other day. The THEAL device (Mectronic, Bergamo) allows to deliver 4 wavelengths (650 nm, 810 nm, 980 nm and 1064 nm), with continuous and pulsed mode, with power up to 20 W. Patients will perform stretching exercise like those of the control group. |
| Control group | No intervention | –Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks. 1. Hamstring and ankle plantar flexor stretch (straight leg raise in supine position) 2. self-stretching of the surae muscles: the patient bends forward in a standing position with the affected foot farthest from the wall, keeping the heel on the floor; 3. the soleus muscle is exercised with the knee flexed and the gastrocnemius muscle with the knee extended 4. Plantar fascia self-stretch: In a seated position, the patient crosses the affected foot over the contralateral thigh and passively extends the metatarsophalangeal joints . In the first session, the volunteers will be trained on how to perform the exercises correctly and will be monitored once a week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- history of heel pain for at least 3 months prior to enrollment,
- Pain on palpation of the medial calcaneal tubercle or proximal plantar fascia,
- plantar fascia thickness of 4.0 mm or greater.
Key exclusion criteria (17 listed)
- age below 18 years of age
- history of systemic disease
- pregnancy
- Previous surgery on the lower limbs
- diagnosis of fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel joint syndrome
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 |
|---|---|---|
| THEAL (Mectronic, Bergamo)Also: laserlaser therapy high intensity | Device | experimental group |
Primary outcome
recovery of pain
Time frame: change between baseline to 2 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
recovery of pain
Time frame: change between baseline to 6 months
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
4 secondary outcomes
functional recovery
Time frame: change between baseline to 2 months
functional recovery
Time frame: change between baseline to 6 months
perception of clinical improvement
Time frame: change between baseline to 2 months
perception of clinical improvement
Time frame: change between baseline to 6 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 25 May 2025.
- Background: PubMed 12851352DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing THEAL (Mectronic, Bergamo) 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 3 inclusion and 17 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 25 May 2025. 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?
recovery of pain (time frame: change between baseline to 2 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?
On the ClinicalTrials.gov record for NCT05925777, which also lists 1 linked publication.
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 25 May 2025.