search
Back to results

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

Primary Purpose

Fasciitis, Plantar

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
platelet rich plasma
Normal saline
Sponsored by
William Beaumont Army Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring Heel Pain, extracorporeal shock wave therapy, ESWT, shock wave, Soldiers, Platelet rich plasma, PRP, Autologous conditioned plasma, Military

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • William Beaumont Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Platelet Rich Plasma Injection Group

Placebo injection group

Arm Description

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

shockwave therapy with placebo normal saline injection

Outcomes

Primary Outcome Measures

Visual analog scale (VAS)
Decreased first step pain over time with single treatment of ESWT & PRP as measured by the VAS

Secondary Outcome Measures

Functional Ankle Ability Measure (FAAM)
functionality scale
Functional Ankle Ability Measure extended sports scale
sports subscale for sport related activity
return to activity
achieving minimal clinical important difference (MCID) on FAAM sport scale
repeat treatment threshold
Decreased need for repeat ESWT as proven by achieving MCID on FAAM

Full Information

First Posted
January 26, 2016
Last Updated
April 30, 2018
Sponsor
William Beaumont Army Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02668510
Brief Title
RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
William Beaumont Army Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar
Keywords
Heel Pain, extracorporeal shock wave therapy, ESWT, shock wave, Soldiers, Platelet rich plasma, PRP, Autologous conditioned plasma, Military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Platelet Rich Plasma Injection Group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo injection group
Arm Type
Placebo Comparator
Arm Description
shockwave therapy with placebo normal saline injection
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Other Intervention Name(s)
PRP
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Placebo
Intervention Description
placebo injection of normal saline immediately following shockwave therapy
Primary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
Decreased first step pain over time with single treatment of ESWT & PRP as measured by the VAS
Time Frame
3, 6, 12, 24 weeks
Secondary Outcome Measure Information:
Title
Functional Ankle Ability Measure (FAAM)
Description
functionality scale
Time Frame
3, 6, 12, 24 weeks
Title
Functional Ankle Ability Measure extended sports scale
Description
sports subscale for sport related activity
Time Frame
3, 6, 12, 24 weeks
Title
return to activity
Description
achieving minimal clinical important difference (MCID) on FAAM sport scale
Time Frame
3, 6, 12, 24 weeks
Title
repeat treatment threshold
Description
Decreased need for repeat ESWT as proven by achieving MCID on FAAM
Time Frame
3, 6, 12, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timothy B Pekari, DSc
Phone
9157421693
Email
timothy.b.pekari.mil@mail.mil
First Name & Middle Initial & Last Name or Official Title & Degree
Justin D Orr, MD
Phone
9157421693
Email
justin.d.orr.mil@mail.mil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy B Pekari, DSc
Organizational Affiliation
WBAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amanda L Allen, MD
Organizational Affiliation
WBAMC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lola Norton
Organizational Affiliation
WBAMC
Official's Role
Study Director
Facility Information:
Facility Name
William Beaumont Army Medical Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lola Norton
Phone
915-742-0993
Email
lola.norton@us.army.mil
First Name & Middle Initial & Last Name & Degree
Arturo Alvarez
Phone
915-742-6075
Email
Arturo.AlvarezIII@us.army.mil

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
15134609
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. doi: 10.1177/107110070402500504.
Results Reference
background
PubMed Identifier
23973504
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.
Results Reference
background
PubMed Identifier
23813184
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.
Results Reference
background
PubMed Identifier
16309613
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. doi: 10.1177/107110070502601113.
Results Reference
background
PubMed Identifier
20880482
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.
Results Reference
background
PubMed Identifier
24662810
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.
Results Reference
background
PubMed Identifier
18326832
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.
Results Reference
background
PubMed Identifier
24426857
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.
Results Reference
background
PubMed Identifier
26311907
Citation
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.
Results Reference
background
PubMed Identifier
19952249
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs