Recruiting

Plantar Fasciitis

Sponsor:

University of Pennsylvania

Code:

NCT03231150

Conditions

Plantar Fascitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Local Steroid Injection into the plantar heel

Ultrasound Guided Injection

Anatomical Guided injection

Study Details

Brief 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.

Conditions

Plantar Fascitis

Study ID

NCT03231150

Start date

Mar 28, 2017

Status verified date

Oct, 2025

Completion date

Oct 31, 2026

Anticipated

Primary completion date

Jun 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

62 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Anatomical injection

Once patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to "locate" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.

experimental: Ultrasound Guided Injection

Once patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.

Interventions

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.

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

Anatomical Guided injection

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

Primary outcome measure

  • Change in VAS pain score at post injection periods with use of USGI [ Time Frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up ]
  • Change in VAS pain score at post injection periods with use of ATGI [ Time Frame: Baseline to 3 months, 6 month, 9 month, and 12 month follow up ]

Central Contacts and Locations

Central contacts

Donald S Malay, DPM

4848440755malaydsm@gmail.com

Hye R Kim, DPM

443-765-6588hearin86@gmail.com

Locations

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Donald S Malay, DPM

484-844-0755malaydsm@gmail.com

More Information

Sponsor

University of Pennsylvania

Last update posted

Oct 10, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2025-10-10.