Fasciitis, Plantar Clinical Trial
— THEAL-FOfficial title:
Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
Verified date | June 2023 |
Source | Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 24 |
Est. completion date | January 1, 2027 |
Est. primary completion date | July 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. history of heel pain for at least 3 months prior to enrollment, 2. Pain on palpation of the medial calcaneal tubercle or proximal plantar fascia, 3. plantar fascia thickness of 4.0 mm or greater. Exclusion Criteria: 1. age below 18 years of age 2. history of systemic disease 3. pregnancy 4. Previous surgery on the lower limbs 5. diagnosis of fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel joint syndrome 6. body mass index (BMI) greater than 35 kg/m2 7. wounds, infections in the treatment area 8. altered sensation in the treatment area 9. skin pigmentation alterations in the area to be treated (tattoo, dyschromia) 10. metal implants in the treatment area 11. History of oral or injected corticosteroid therapy within the past six weeks 12. Diagnosis of neurological heel pain (radiculopathy) 13. diagnosis of systemic inflammatory arthritis (rheumatoid arthritis, etc.) 14. other acute pathologies (febrile fever, cold, etc.) requiring treatment 15. other painful conditions requiring painkillers (toothache, back pain, etc.) 16. neoplasms 17. cardiac pacemaker or other device. |
Country | Name | City | State |
---|---|---|---|
Italy | Angela Notarnicola | Bari |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari |
Italy,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | band thickness | ultrasound image to measure of fascia thickness, measured in mm | change between baseline to 2 months | |
Other | band thickness | ultrasound image to measure of fascia thickness, measured in mm | change between baseline to 6 months | |
Other | presence of edema | MRI image to verify the presence or absence of bone edema (dichotomous answer) | change between baseline to 2 months | |
Other | presence of edema | MRI image to verify the presence of absence or bone edema (dichotomous answer) | change between baseline to 6 months | |
Primary | 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." | change between baseline to 2 months | |
Primary | 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." | change between baseline to 6 months | |
Secondary | 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. | change between baseline to 2 months | |
Secondary | 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. | change between baseline to 6 months | |
Secondary | perception of clinical improvement | Maudsley and Roles scale scores range from 0-4 points for excellent to poor | change between baseline to 2 months | |
Secondary | perception of clinical improvement | Maudsley and Roles scale scores range from 0-4 points for excellent to poor | change between baseline to 6 months |
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