Clinical trial NCT02668510: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Fasciitis, Plantar
Keywords: Heel Pain
extracorporeal shock wave therapy
ESWT
shock wave
Soldiers
Platelet rich plasma
PRP
Autologous conditioned plasma
Military
Lead sponsor: William Beaumont Army Medical Center
Sponsor class: FED
First posted: 2016-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 3, 6, 12, 24 weeks
Secondary outcomes:
measure: Functional Ankle Ability Measure (FAAM)
timeFrame: 3, 6, 12, 24 weeks
measure: Functional Ankle Ability Measure extended sports scale
timeFrame: 3, 6, 12, 24 weeks
measure: return to activity
timeFrame: 3, 6, 12, 24 weeks
measure: repeat treatment threshold
timeFrame: 3, 6, 12, 24 weeks
Other outcomes:
Locations:
city: El Paso
country: United States
facility: William Beaumont Army Medical Center
state: Texas
Study officials:
affiliation: WBAMC
name: Timothy B Pekari, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: WBAMC
name: Amanda L Allen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: WBAMC
name: Lola Norton
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.