RecruitingNot ApplicableNCT03231150

Plantar Fasciitis Randomized Clinical Control Trial

Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis

Sponsor

University of Pennsylvania

Enrollment

62 participants

Start Date

Mar 28, 2017

Study Type

INTERVENTIONAL

Conditions

Plantar Fascitis

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

Min Age: 18 Years

Inclusion Criteria7

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 Criteria10

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 of the components of the injection therapy
Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation
Existing or prior osteomyelitis of the involved calcaneus
Unable to consent to participation in clinical research or currently be involved in another clinical investigation.

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Interventions

PROCEDURELocal Steroid Injection into the plantar heel

Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml.

PROCEDUREUltrasound Guided Injection

Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach

PROCEDUREAnatomical Guided injection

Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.