NCT03231150 · University of Pennsylvania
Plantar Fasciitis Randomized Clinical Control Trial
(PF-RCT)
What this study is 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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.
Where
- Philadelphia, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 10, 2025 · Source of record for eligibility and locations