Plantar Fasciitis Randomized Clinical Control Trial

Plantar Fascitis Clinical Trial

— PF-RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231150
• Other study ID #: PPMC-04
• Status: Recruiting
• Phase: N/A
• Start date: March 28, 2017
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2024
• Source: University of Pennsylvania
• Contact: Donald S Malay, DPM
• Phone: 4848440755
• Email: malaydsm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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.. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Observation of normal plantar fascia after treatment as measured by ultrasound (US)		Baseline to 12 month follow up
Secondary	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
Secondary	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