Study Results
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Basic Information
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RECRUITING
NA
62 participants
INTERVENTIONAL
2017-03-28
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Anatomical injection
Once patient has been randomized, if placed in the anatomically-guided injection group, the medial band of the plantar fascia origin on the calcaneus will be palpated and marked approximately. In the clinical setting, a sham ultrasound machine will be utilized to "locate" the plantar fascia keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.
Local Steroid Injection into the plantar heel
Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml.
Anatomical Guided injection
Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
Ultrasound Guided Injection
Once patient has been randomized, if placed in the USGI group, the patient will be scheduled for an ultrasound therapy in the radiology department at Penn Presbyterian Medical Center. In this setting, the patient will be informed that in order to keep them blinded, that all patients must have either injection performed in the radiology department and that the ultrasound machine utilized will either be on or off during the injection keeping the patient blinded to the treatment modality. The area will then be prepped with alcohol to the medial heel and utilizing a medial approach, an injection of 0.5 cc 0.5% bupivacaine, 0.5 cc dexamethasone and 0.25 cc triamcinolone acetamide 40 mg/mL will be administered into the area surrounding the plantar fascia. The area will then be cleaned will alcohol and dressed with a small elastic bandage.
Local Steroid Injection into the plantar heel
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
Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach
Interventions
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Local Steroid Injection into the plantar heel
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
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
Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
Eligibility Criteria
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Inclusion Criteria
* ≥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.
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Donald S Malay, DPM
Role: PRINCIPAL_INVESTIGATOR
Penn Presbyterian Medical Center
Locations
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Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Ang TW. The effectiveness of corticosteroid injection in the treatment of plantar fasciitis. Singapore Med J. 2015 Aug;56(8):423-32. doi: 10.11622/smedj.2015118.
Weil L Jr, Glover JP, Weil LS Sr. A new minimally invasive technique for treating plantar fasciosis using bipolar radiofrequency: a prospective analysis. Foot Ankle Spec. 2008 Feb;1(1):13-8. doi: 10.1177/1938640007312318..
Young CC, Rutherford DS, Niedfeldt MW. Treatment of plantar fasciitis. Am Fam Physician. 2001 Feb 1;63(3):467-74, 477-8.
Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
Wessel J. The reliability and validity of pain threshold measurements in osteoarthritis of the knee. Scand J Rheumatol. 1995;24(4):238-42. doi: 10.3109/03009749509100881.
Lundeberg T, Lund I, Dahlin L, Borg E, Gustafsson C, Sandin L, Rosen A, Kowalski J, Eriksson SV. Reliability and responsiveness of three different pain assessments. J Rehabil Med. 2001 Nov;33(6):279-83. doi: 10.1080/165019701753236473.
Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.
Budiman-Mak E, Conrad KJ, Roach KE. The Foot Function Index: a measure of foot pain and disability. J Clin Epidemiol. 1991;44(6):561-70. doi: 10.1016/0895-4356(91)90220-4.
Barnett S, Campbell R, Harvey I. The Bristol Foot Score: developing a patient-based foot-health measure. J Am Podiatr Med Assoc. 2005 May-Jun;95(3):264-72. doi: 10.7547/0950264.
Tsai WC, Wang CL, Tang FT, Hsu TC, Hsu KH, Wong MK. Treatment of proximal plantar fasciitis with ultrasound-guided steroid injection. Arch Phys Med Rehabil. 2000 Oct;81(10):1416-21. doi: 10.1053/apmr.2000.9175.
Tsai WC, Hsu CC, Chen CP, Chen MJ, Yu TY, Chen YJ. Plantar fasciitis treated with local steroid injection: comparison between sonographic and palpation guidance. J Clin Ultrasound. 2006 Jan;34(1):12-6. doi: 10.1002/jcu.20177.
Chen CM, Chen JS, Tsai WC, Hsu HC, Chen KH, Lin CH. Effectiveness of device-assisted ultrasound-guided steroid injection for treating plantar fasciitis. Am J Phys Med Rehabil. 2013 Jul;92(7):597-605. doi: 10.1097/PHM.0b013e318278a831.
Li Z, Xia C, Yu A, Qi B. Ultrasound- versus palpation-guided injection of corticosteroid for plantar fasciitis: a meta-analysis. PLoS One. 2014 Mar 21;9(3):e92671. doi: 10.1371/journal.pone.0092671. eCollection 2014.
Other Identifiers
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PPMC-04
Identifier Type: -
Identifier Source: org_study_id
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