Angela Notarnicola
Bari, 70124, Italy
NCT Number: NCT05925777
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Bari, 70124, Italy
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
laser therapy high intensity
Other names: laser
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."
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."
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.
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.
Time frame: change between baseline to 2 months
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time frame: change between baseline to 6 months
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time frame: change between baseline to 2 months
ultrasound image to measure of fascia thickness, measured in mm
Time frame: change between baseline to 6 months
ultrasound image to measure of fascia thickness, measured in mm
Time frame: change between baseline to 2 months
MRI image to verify the presence or absence of bone edema (dichotomous answer)
Time frame: change between baseline to 6 months
MRI image to verify the presence of absence or bone edema (dichotomous answer)
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Other
Acronym: THEAL-F
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06318910
Fasciitis, Fasciitis, Plantar
Bangkok, Changwat Nakhon Pathom, Thailand
View Trial DetailsNCT06697834
Aponeurosis Contusion, Fasciitis
Domont, France
View Trial DetailsNCT06305507
Fasciitis, Fasciitis, Plantar
Seville, Andalusia, Spain
View Trial DetailsNCT06426667
Fasciitis, Fasciitis, Plantar
Ankara, Turkey (Türkiye)
View Trial Details