Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema (THEAL-F)
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ClinicalTrials.gov Identifier: NCT05925777 |
Recruitment Status :
Recruiting
First Posted : June 29, 2023
Last Update Posted : September 6, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fasciitis, Plantar | Device: THEAL (Mectronic, Bergamo) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | randomized prospective |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema |
Actual Study Start Date : | August 1, 2023 |
Estimated Primary Completion Date : | July 1, 2026 |
Estimated Study Completion Date : | January 1, 2027 |
Arm | Intervention/treatment |
---|---|
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 Name: laser |
No Intervention: Control group
Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks.
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. |
- 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."
- 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.
- 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.
- 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
- 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
- band thickness [ Time Frame: change between baseline to 2 months ]ultrasound image to measure of fascia thickness, measured in mm
- band thickness [ Time Frame: change between baseline to 6 months ]ultrasound image to measure of fascia thickness, measured in mm
- presence of edema [ Time Frame: change between baseline to 2 months ]MRI image to verify the presence or absence of bone edema (dichotomous answer)
- presence of edema [ Time Frame: change between baseline to 6 months ]MRI image to verify the presence of absence or bone edema (dichotomous answer)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05925777
Italy | |
Angela Notarnicola | Recruiting |
Bari, Italy, 70124 | |
Contact: Angela Notarnicola 0805592938 angelanotarnicola@yahoo.it |
Responsible Party: | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
ClinicalTrials.gov Identifier: | NCT05925777 |
Other Study ID Numbers: |
THEAL-fasc |
First Posted: | June 29, 2023 Key Record Dates |
Last Update Posted: | September 6, 2023 |
Last Verified: | June 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
laser foot ankle pain |
Fasciitis Fasciitis, Plantar Musculoskeletal Diseases Foot Diseases |