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Plantar Fasciitis Randomized Clinical Control Trial

ConditionPlantar Fascitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Local Steroid Injection into the plantar heel

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

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

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Anatomical injectionActive comparator 2 interventions
Group B: Ultrasound Guided InjectionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Change in VAS pain score at post injection periods with use of USGI

with the primary efficacy endpoint being the 3-month post injection pain score

Time frame
Baseline to 3 months, 6 month, 9 month, and 12 month follow up
2

Change in VAS pain score at post injection periods with use of ATGI

with the primary efficacy endpoint being the 3-month post injection pain score

Time frame
Baseline to 3 months, 6 month, 9 month, and 12 month follow up

Secondary outcomes

1

Observation of normal plantar fascia after treatment as measured by ultrasound (US)

Time frame
Baseline to 12 month follow up
2

Foot-related quality of life outcomes as measured with use of the FFI

Time frame
Baseline to 3 months, 6 month, 9 month, and 12 month follow up
3

Foot-related quality of life outcomes as measured with use of the BFS

Time frame
Baseline to 3 months, 6 month, 9 month, and 12 month follow up

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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