NCT03231150

Plantar Fasciitis Randomized Clinical Control Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Clinically, proximal PF causes plantar heel pain, which may extend into the proximal portion of the plantar longitudinal arch. Typically, the pain is most notable upon initial weight bearing ambulation (post-static dyskinesia, PSD), such as the first step in the morning or following a period of non-weight bearing or rest. This can be attributed to walking on hard surfaces or barefoot, prolonged weight bearing activity, inadequate stretching and use of poor footwear, as well as increased amounts of walking. Standard treatment of PF includes the use of foot orthotics, both pre-fabricated and custom molded, physical therapy and myotendinous stretching, splinting or strapping the foot, nonsteroidal anti-inflammatory drugs, ice, and corticosteroid injections. Ultrasonography (US) can be useful for examining the plantar fascia, which typically measures between 2 mm to 4 mm in thickness, and findings indicative of PF include diffuse hypoechogenicity at the calcaneal attachment of the plantar fascia, loss of definition between the plantar fascia and the surrounding soft tissues, peri-insertion edema, and thickness over 4.5 mm. Local infiltration of corticosteroids has been used to treat PF since the 1950s. Despite this being a well established treatment, there are still unexamined features of this form of intervention, including the method of injection, type of steroid used, concurrent use of localanesthetic agents, concurrent use of orthoses and/or supportive arch strapping, concurrent physical therapy, and the use of ultrasonographic guidance of the corticosteroid injection. 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.

Conditions

• Plantar Fascitis

Interventions

Type	Name	Description
PROCEDURE	Local 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.
PROCEDURE	Ultrasound 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
PROCEDURE	Anatomical Guided injection	Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.

Timeline

• Start date: 2017-03-28
• Primary completion: 2026-06-15
• Completion: 2026-10-31
• First posted: 2017-07-27
• Last updated: 2025-10-10

Locations

1 site across 1 country: United States