Plantar Fasciitis Randomized Clinical Control Trial (PF-RCT)

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

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 Overview

• Status: Recruiting
• Conditions: Plantar Fascitis
• Intervention / Treatment: Procedure: Local Steroid Injection into the plantar heel; Procedure: Anatomical Guided injection; Procedure: Ultrasound Guided Injection

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Donald S Malay, DPM; Phone Number: 4848440755; Email: malaydsm@gmail.com
• Study Contact Backup: Name: Hye R Kim, DPM; Phone Number: 443-765-6588; Email: hearin86@gmail.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center
      • Contact: Donald S Malay, DPM; Phone Number: 484-844-0755; Email: malaydsm@gmail.com
      • Sub-Investigator: Brittany Winfield, DPM
      • Sub-Investigator: Lauren E Pruner, DPM
      • Sub-Investigator: Raafae Hussain, DPM
      • Sub-Investigator: Paul Niziolek, MD
      • Sub-Investigator: Viviane Khoury, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Procedure: 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.; Procedure: Anatomical Guided injection; Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
Experimental: 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.	Procedure: 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.; Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline to 3 months, 6 month, 9 month, and 12 month follow up
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	Baseline to 3 months, 6 month, 9 month, and 12 month follow up

Secondary Outcome Measures

Outcome Measure	Time Frame
Observation of normal plantar fascia after treatment as measured by ultrasound (US)	Baseline to 12 month follow up
Foot-related quality of life outcomes as measured with use of the FFI	Baseline to 3 months, 6 month, 9 month, and 12 month follow up
Foot-related quality of life outcomes as measured with use of the BFS	Baseline to 3 months, 6 month, 9 month, and 12 month follow up

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Donald S Malay, DPM, Penn Presbyterian Medical Center

Publications and helpful links

General Publications

• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.
• 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. Erratum In: Am Fam Physician 2001 Aug 15;64(4):570.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2017
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: July 21, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: PPMC-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No