Plantar Fasciitis Randomized Clinical Control Trial

NCT03231150 | Recruiting

• 1 other identifier: PPMC-04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Plantar Fascitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Anatomical injection

ACTIVE COMPARATOR

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; Procedure: Anatomical Guided injection

Ultrasound Guided Injection

EXPERIMENTAL

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; Procedure: Ultrasound Guided Injection

Interventions

Local Steroid Injection into the plantar heel PROCEDURE

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 injection; Ultrasound Guided Injection

Ultrasound Guided Injection PROCEDURE

Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach

Ultrasound Guided Injection

Anatomical Guided injection PROCEDURE

Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.

Anatomical injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (13)

• 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.

  PMID: 26311907 RESULT

• 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..

  PMID: 19825686 RESULT

• Young CC, Rutherford DS, Niedfeldt MW. Treatment of plantar fasciitis. Am Fam Physician. 2001 Feb 1;63(3):467-74, 477-8.

  PMID: 11272297 RESULT

• Buchbinder R. Clinical practice. Plantar fasciitis. N Engl J Med. 2004 May 20;350(21):2159-66. doi: 10.1056/NEJMcp032745. No abstract available.

  PMID: 15152061 RESULT

• 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.

  PMID: 7481589 RESULT

• 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.

  PMID: 11766958 RESULT

• 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.

  PMID: 11733293 RESULT

• 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.

  PMID: 2037861 RESULT

• 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.

  PMID: 15901814 RESULT

• 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.

  PMID: 11030509 RESULT

• 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.

  PMID: 16353228 RESULT

• 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.

  PMID: 23221670 RESULT

• 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.

  PMID: 24658102 RESULT

Study Officials

• Donald S Malay, DPM

  Penn Presbyterian Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donald S Malay, DPM

CONTACT

4848440755; malaydsm@gmail.com

Hye R Kim, DPM

CONTACT

443-765-6588; hearin86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants that do not experience at least a 50% reduction in pain following phase 1 will undergo randomization to either USGI or ATGI, both injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml. Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach, whereas execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach. The patients will be randomized into these groups by a specialized statistical computerized system that randomly selects a number to the participant. An even or an odd number represents which form of injection the patient is to receive.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This investigation will be chronologically divided into four stages that will commence after procurement of institutional review board (IRB) approval and funding, namely: 1) screening and enrollment, 2) random treatment allocation and treatment, 3) data collection and analysis, and 4) presentation and publication. We anticipate that it will take approximately 23.5 months to execute the clinical experiment and to prepare the report for publication.

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 27, 2017
• Study Start: March 28, 2017
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: October 10, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)