RECRUITING

Plantar Fasciitis Randomized Clinical Control Trial

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2017-03-28

Study Completion:2025-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03231150

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Donald S Malay, DPM

CONTACT

4848440755

malaydsm@gmail.com

Hye R Kim, DPM

CONTACT

443-765-6588

hearin86@gmail.com

Principal Investigator

Donald S Malay, DPM

PRINCIPAL_INVESTIGATOR

Penn Presbyterian Medical Center

Study Locations (Sites)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-03-28

Study Completion Date2025-01-31

Study Record Updates

Study Start Date2017-03-28

Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

Plantar Fascitis