RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort

NCT02668510 | Withdrawn

• 1 other identifier: 16/03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant Plantar Fasciitis

Conditions

Fasciitis, Plantar

Keywords

Heel Pain; extracorporeal shock wave therapy; ESWT; shock wave; Soldiers; Platelet rich plasma; PRP; Autologous conditioned plasma; Military

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS

  3, 6, 12, 24 weeks

Secondary Outcomes (4)

• Functional Ankle Ability Measure (FAAM)

  3, 6, 12, 24 weeks

• Functional Ankle Ability Measure extended sports scale

  3, 6, 12, 24 weeks

• return to activity

  3, 6, 12, 24 weeks

• repeat treatment threshold

  3, 6, 12, 24 weeks

Study Arms (2)

Platelet Rich Plasma Injection Group

EXPERIMENTAL

shockwave therapy within standard of care using Ossatron system with intervention injection of platelet rich plasma (PRP) using Arthex system, into the plantar fascia at the calcaneal origin

Biological: platelet rich plasma

Placebo injection group

PLACEBO COMPARATOR

shockwave therapy with placebo normal saline injection

Drug: Normal saline

Interventions

platelet rich plasma BIOLOGICAL

immediately following shockwave therapy the injection of PRP derived from subjects own blood using Arthex double syringe system will be injected at the origin of the plantar fascia at the calcaneous

Also known as: PRP

Platelet Rich Plasma Injection Group

Normal saline DRUG

placebo injection of normal saline immediately following shockwave therapy

Also known as: Placebo

Placebo injection group

Eligibility Criteria

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

You may qualify if:

• years or older
• Patients that are already selected for ESWT for the treatment of resistant plantar fasciitis as part of clinical care under the doctor-patient relationship
• X-ray imaging studies (Plain radiographs) documenting no additional sources for heel pain within 12 months(all x-rays were conducted as part of standard of care and no radiation will be specific to the research study)
• Active Duty Soldier as they are a high demand cohort with increased frequency of plantar fasciitis compared to the general population as outlined by Scher et al.
• Previously tried conservative management meeting referral to Orthopaedics: Pain medications, taping, orthoses, night splinting or physical therapy
• Body Mass Index (BMI) \<40kg/m2

You may not qualify if:

• History of trauma\* or previous injury to heel requiring operative intervention
• All Soldiers pending medical board evaluation or punitive action
• History of connective tissue disorder (e.g., Marfan's Syndrome, Ehlers-Danlos disease, Rheumatoid Arthritis, etc.)
• Leaving the geographical area permanently or for extended periods of time forcing loss to follow up
• Treatment for plantar fasciitis with injection within the last 6 months
• Surgical indication or internal derangement of the foot
• Chronic pain conditions
• Pregnancy
• Tarsal tunnel syndrome
• Baxter's neuritis
• Rigid flat foot
• Active infection of the Foot overlying the injection area
• Use of immunomodulators, immunosuppressives, or chemotherapeutic agents
• Allergy or hypersensitivity to any of the proposed treatment medications
• Any other clinically significant acute or chronic medical conditions (e.g., bleeding disorder) that, in the judgment of the Investigator, would preclude the use of a PRP or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.

Sponsors & Collaborators

• Edna Rath: lead

Study Sites (1)

William Beaumont Army Medical Center

El Paso, Texas, 79920, United States

Location

Related Publications (10)

• Ogden JA, Cross GL, Williams SS. Bilateral chronic proximal plantar fasciopathy: treatment with electrohydraulic orthotripsy. Foot Ankle Int. 2004 May;25(5):298-302. doi: 10.1177/107110070402500504.

  PMID: 15134609 BACKGROUND

• Chew KT, Leong D, Lin CY, Lim KK, Tan B. Comparison of autologous conditioned plasma injection, extracorporeal shockwave therapy, and conventional treatment for plantar fasciitis: a randomized trial. PM R. 2013 Dec;5(12):1035-43. doi: 10.1016/j.pmrj.2013.08.590. Epub 2013 Aug 22.

  PMID: 23973504 BACKGROUND

• Aqil A, Siddiqui MR, Solan M, Redfern DJ, Gulati V, Cobb JP. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: a meta-analysis of RCTs. Clin Orthop Relat Res. 2013 Nov;471(11):3645-52. doi: 10.1007/s11999-013-3132-2. Epub 2013 Jun 28.

  PMID: 23813184 BACKGROUND

• Martin RL, Irrgang JJ, Burdett RG, Conti SF, Van Swearingen JM. Evidence of validity for the Foot and Ankle Ability Measure (FAAM). Foot Ankle Int. 2005 Nov;26(11):968-83. doi: 10.1177/107110070502601113.

  PMID: 16309613 BACKGROUND

• Metzner G, Dohnalek C, Aigner E. High-energy Extracorporeal Shock-Wave Therapy (ESWT) for the treatment of chronic plantar fasciitis. Foot Ankle Int. 2010 Sep;31(9):790-6. doi: 10.3113/FAI.2010.0790.

  PMID: 20880482 BACKGROUND

• Yin MC, Ye J, Yao M, Cui XJ, Xia Y, Shen QX, Tong ZY, Wu XQ, Ma JM, Mo W. Is extracorporeal shock wave therapy clinical efficacy for relief of chronic, recalcitrant plantar fasciitis? A systematic review and meta-analysis of randomized placebo or active-treatment controlled trials. Arch Phys Med Rehabil. 2014 Aug;95(8):1585-93. doi: 10.1016/j.apmr.2014.01.033. Epub 2014 Mar 21.

  PMID: 24662810 BACKGROUND

• de Mos M, van der Windt AE, Jahr H, van Schie HT, Weinans H, Verhaar JA, van Osch GJ. Can platelet-rich plasma enhance tendon repair? A cell culture study. Am J Sports Med. 2008 Jun;36(6):1171-8. doi: 10.1177/0363546508314430. Epub 2008 Mar 7.

  PMID: 18326832 BACKGROUND

• O'Malley MJ, Vosseller JT, Gu Y. Successful use of platelet-rich plasma for chronic plantar fasciitis. HSS J. 2013 Jul;9(2):129-33. doi: 10.1007/s11420-012-9321-9. Epub 2013 May 18.

  PMID: 24426857 BACKGROUND

• 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 BACKGROUND

• Scher DL, Belmont PJ Jr, Bear R, Mountcastle SB, Orr JD, Owens BD. The incidence of plantar fasciitis in the United States military. J Bone Joint Surg Am. 2009 Dec;91(12):2867-72. doi: 10.2106/JBJS.I.00257.

  PMID: 19952249 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Timothy B Pekari, DSc

  WBAMC

  PRINCIPAL INVESTIGATOR

• Amanda L Allen, MD

  WBAMC

  PRINCIPAL INVESTIGATOR

• Lola Norton

  WBAMC

  STUDY DIRECTOR

• Desiree d diebold, md

  wbamc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Human Protection Director

Study Record Dates

• First Submitted: January 26, 2016
• First Posted: January 29, 2016
• Study Start: January 1, 2016
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)