NCT03231150 Plantar Fasciitis Randomized Clinical Control Trial
| NCT ID | NCT03231150 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Plantar Fascitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2017-03-28 |
| Primary Completion | 2026-06-15 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
The primary aim of this clinical experiment is to compare, in terms of pain relief measured using the 10-cm visual analog scale (VAS) pain score (5-7), the clinical results of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroid for the treatment of proximal PF. Secondary aims will be to compare foot-related quality of life, as measured using the Foot Function Index (FFI)and the Bristol Foot Score (BFS), between the injection groups, and also to compare the pre-injection to late-term post-injection thickness of the plantar fascia as measured in the nested USGI group.
Eligibility Criteria
Inclusion Criteria: * Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur * ≥18 years of age * Male or non-pregnant female of any ethnicity or race * Active, former or non smoker * With or without peripheral vascular disease without lower extremity intermittent claudication or rest pain * With or without diabetes mellitus without polyneuropathy * With or without collagen vascular disease without lower extremity wound formation. Exclusion Criteria: * Known drug or alcohol dependence * Chronic pain syndrome or lumbosacral radiculitis * Neurological condition that requires the use of analgesic medications or anti-seizure or neuroleptic medications * Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration * Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radiographically * Pregnant females * Known allergy to any o