History of Changes for Study: NCT05925777

Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema (THEAL-F)

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Study Record Versions

Version	Submitted Date	Changes
1	June 22, 2023	None (earliest Version on record)
2	July 21, 2023	Study Status
3	September 1, 2023	Recruitment Status, Study Status, Contacts/Locations and Oversight

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	THEAL-fasc
Brief Title:	Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema (THEAL-F)
Official Title:	Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
Secondary IDs:

Study Status


Record Verification:	June 2023
Overall Status:	Not yet recruiting
Study Start:	July 1, 2023
Primary Completion:	July 1, 2026 [Anticipated]
Study Completion:	January 1, 2027 [Anticipated]

First Submitted:	June 13, 2023
First Submitted that Met QC Criteria:	June 22, 2023
First Posted:	June 29, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	June 22, 2023
Last Update Posted:	June 29, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief 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.). 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).

Conditions


Conditions:	Fasciitis, Plantar
Keywords:	laser foot ankle pain

Study Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	randomized prospective
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	24 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Experimental: experimental group

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 exercises like those of the control group.

Device: THEAL (Mectronic, Bergamo)

laser therapy high intensity

Other Names:

laser

No Intervention: Control group

Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks.

Hamstring and ankle plantar flexor stretch (straight leg raise in supine position)
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.

Outcome Measures


Primary Outcome Measures:
1.	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."
2.	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."
Secondary Outcome Measures:
1.	functional recovery [ Time Frame: change between baseline to 2 months ] 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.
2.	functional recovery [ Time Frame: change between baseline to 6 months ] 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.
3.	perception of clinical improvement [ Time Frame: change between baseline to 2 months ] Maudsley and Roles scale scores range from 0-4 points for excellent to poor
4.	perception of clinical improvement [ Time Frame: change between baseline to 6 months ] Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Other Outcome Measures:
1.	band thickness [ Time Frame: change between baseline to 2 months ] ultrasound image to measure of fascia thickness, measured in mm
2.	band thickness [ Time Frame: change between baseline to 6 months ] ultrasound image to measure of fascia thickness, measured in mm
3.	presence of edema [ Time Frame: change between baseline to 2 months ] MRI image to verify the presence or absence of bone edema (dichotomous answer)
4.	presence of edema [ Time Frame: change between baseline to 6 months ] MRI image to verify the presence of absence or bone edema (dichotomous answer)

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: 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. Exclusion Criteria: 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 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.

Contacts/Locations


Locations:	Italy
	Angela Notarnicola Bari, Italy, 70124

IPDSharing


Plan to Share IPD:	No

References


Citations:	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
Links:
Available IPD/Information: