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Plantar Fasciitis Randomized Clinical Control Trial

Sponsored by University of Pennsylvania

About this trial

Last updated 3 years ago

Study ID

PPMC-04

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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 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.