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

Fasciitis, Plantar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02668510
• Other study ID #: 16/03
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2017
• Source: William Beaumont Army Medical Center
• Contact: Timothy B Pekari, DSc
• Phone: 9157421693
• Email: timothy.b.pekari.mil[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

The purpose of this proposal is to perform a high-quality pilot study testing the efficacy of ESWT in combination with PRP for the management of resistant plantar fasciitis. We endeavor to determine if the pilot evidence supports a large, randomized study; and to conduct a power analysis for the follow-on study. The proposed pilot study will be a prospective double-blinded randomized controlled trial comparing pain and functionality at the 3 week, 6 week, 12 week and 6 month marks between extracorporeal shock wave therapy (ESWT) with platelet rich plasma (PRP) injection versus extracorporeal shock wave therapy with placebo injection of normal saline.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• • 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.

• Trauma for this research study is defined as a specific event or mechanism of injury, such as a direct blow or twisting injury of the foot that initiated the onset of heel pain. The insidious onset of heel pain with prolonged running or other physical activity is not defined as a traumatic event.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Biological:
• platelet rich plasma
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

Drug:
• Normal saline
placebo injection of normal saline immediately following shockwave therapy

Locations

Country	Name	City	State
United States	William Beaumont Army Medical Center	El Paso	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ogden JA, Cross GL, Williams SS. Bilateral chronic proximal plantar fasciopathy: treatment with electrohydraulic orthotripsy. Foot Ankle Int. 2004 May;25(5):298-302. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Functional Ankle Ability Measure (FAAM)	functionality scale	3, 6, 12, 24 weeks
Secondary	Functional Ankle Ability Measure extended sports scale	sports subscale for sport related activity	3, 6, 12, 24 weeks
Secondary	return to activity	achieving minimal clinical important difference (MCID) on FAAM sport scale	3, 6, 12, 24 weeks
Secondary	repeat treatment threshold	Decreased need for repeat ESWT as proven by achieving MCID on FAAM	3, 6, 12, 24 weeks