Plantar Fasciitis Randomized Clinical Control Trial

Description

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

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Study Overview

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Study Details

Study overview

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.

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

Plantar Fasciitis Randomized Clinical Control Trial

Condition
Plantar Fascitis
Intervention / Treatment

-

Contacts and Locations

Philadelphia

Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Pennsylvania,

Donald S Malay, DPM, PRINCIPAL_INVESTIGATOR, Penn Presbyterian Medical Center

Study Record Dates

2025-01-31