Comparing two injection methods for treating plantar fasciitis

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

This study tests which injection method, ultrasound-guided or anatomic topography-guided, works better to relieve pain in people with plantar fasciitis.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pennsylvania (other)
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT03231150 on ClinicalTrials.gov

What this trial studies

This clinical experiment aims to evaluate the effectiveness of ultrasound-guided injection (USGI) versus anatomic topography-guided injection (ATGI) of corticosteroids for pain relief in patients with proximal plantar fasciitis. The primary outcome will be measured using a visual analog scale (VAS) for pain, while secondary outcomes will assess foot-related quality of life through the Foot Function Index (FFI) and Bristol Foot Score (BFS). Additionally, the study will analyze changes in the thickness of the plantar fascia in the USGI group over time. Participants will receive either injection method to determine which provides better clinical results.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with pain in the proximal plantar fascia, with or without a calcaneal bone spur.

Not a fit: Patients with chronic pain syndromes, neurological conditions requiring analgesics, or those with significant vascular issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients suffering from plantar fasciitis.

How similar studies have performed: Previous studies have shown varying success with corticosteroid injections for plantar fasciitis, but the specific comparison of injection techniques in this study is relatively novel.

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 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 this trial is running

Philadelphia, Pennsylvania

• Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Donald S Malay, DPM — Penn Presbyterian Medical Center
• Study coordinator: Donald S Malay, DPM

Conditions: Plantar Fascitis