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Plantar Fasciitis Randomized Clinical Control Trial

2017-07-28 12:08:22 | BioPortfolio

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.

Description

Clinically, proximal PF causes plantar heel pain, which may extend into the proximal portion of the plantar longitudinal arch. Typically, the pain is most notable upon initial weight bearing ambulation (post-static dyskinesia, PSD), such as the first step in the morning or following a period of non-weight bearing or rest. This can be attributed to walking on hard surfaces or barefoot, prolonged weight bearing activity, inadequate stretching and use of poor footwear, as well as increased amounts of walking. Standard treatment of PF includes the use of foot orthotics, both pre-fabricated and custom molded, physical therapy and myotendinous stretching, splinting or strapping the foot, nonsteroidal anti-inflammatory drugs, ice, and corticosteroid injections. Ultrasonography (US) can be useful for examining the plantar fascia, which typically measures between 2 mm to 4 mm in thickness, and findings indicative of PF include diffuse hypoechogenicity at the calcaneal attachment of the plantar fascia, loss of definition between the plantar fascia and the surrounding soft tissues, peri-insertion edema, and thickness over 4.5 mm. Local infiltration of corticosteroids has been used to treat PF since the 1950s. Despite this being a well established treatment, there are still unexamined features of this form of intervention, including the method of injection, type of steroid used, concurrent use of localanesthetic agents, concurrent use of orthoses and/or supportive arch strapping, concurrent physical therapy, and the use of ultrasonographic guidance of the corticosteroid injection. 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.

Study Design

Conditions

Plantar Fascitis

Intervention

Local Steroid Injection into the plantar heel, Ultrasound Guided Injection, Anatomical Guided injection

Location

Penn Presbyterian Medical Center
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-07-28T12:08:22-0400

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Medical and Biotech [MESH] Definitions

Inflammation of the thick tissue on the bottom of the foot (plantar fascia) causing HEEL pain. The plantar fascia (also called plantar aponeurosis) are bands of fibrous tissue extending from the calcaneal tuberosity to the TOES. The etiology of plantar fasciitis remains controversial but is likely to involve a biomechanical imbalance. Though often presenting along with HEEL SPUR, they do not appear to be causally related.

A bony outgrowth on the lower surface of the CALCANEUS. Though often presenting along with plantar fasciitis (FASCIITIS, PLANTAR), they are not considered causally related.

A fibromatosis of the plantar fascia characterized by thickening of the fibrous bands on the plantar aponeurosis in the sole of the foot and toes.

The collecting of fetal blood samples via ultrasound-guided needle aspiration of the blood in the umbilical vein.

Adverse reactions that occur initially at the site of injection or infusion. Milder type is confined to a local allergic flare reaction. A more severe reaction is caused by extravasation of VESICANTS from the blood vessel at the site of injection and can cause damage to the surrounding tissue. In tumor flare reaction symptoms involve well beyond the injection site such as an increase in the tumor size and tumor markers levels, bone pain, and HYPERCALCEMIA.

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