What this study is
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's being tested
- Local Steroid Injection into the plantar heel
Intervention · PROCEDURE
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
Intervention · PROCEDURE
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
Intervention · PROCEDURE
Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
Study details
- Official title
- Randomized Clinical Study to Evaluate Ultrasound Guided Injection Therapy Versus Topographic Injection Therapy for Plantar Fasciitis
- Sponsor
- University of Pennsylvania
- Conditions
- Plantar Fascitis
- Enrolling
- 62 people
- Starts
- 2017-03-28
- Est. completion
- 2026-10-31
- Design
- Double-blind, randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openPenn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
- Donald S Malay, DPM · Contact484-844-0755malaydsm@gmail.com
- Brittany Winfield, DPM · Sub-investigator
- Lauren E Pruner, DPM · Sub-investigator
- Raafae Hussain, DPM · Sub-investigator
- Paul Niziolek, MD · Sub-investigator
- Viviane Khoury, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of Pennsylvania
Study ID PPMC-04
Principal investigator
Donald S Malay, DPM
Penn Presbyterian Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.