Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

A Randomized, Controlled, Multi-site Trial of a Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

Determine if the addition of a specific acupuncture protocol to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.

Study Overview

• Status: Completed
• Conditions: Plantar Fascitis
• Intervention / Treatment: Device: Intervention + Standard of care; Other: Standard of care

Detailed Description

This is a randomized, controlled, multi-site trial investigating whether a specific acupuncture protocol can improve pain and function in adults with plantar fasciosis when added to standard of care treatment. The investigators hypothesize that there will be a significant improvement in both pain and functional outcomes, both acutely and over time, in the experimental group compared to the control group.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Eglin Air Force Base, Florida, United States, 32542
      • 96th Medical Group
  • Illinois
    • Belleville, Illinois, United States, 62225
      • Scott AFB
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Mike O'Callaghan Military Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

**Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study**

Inclusion Criteria:

• Male and female DoD beneficiaries, aged 18 to 74 years, who have been diagnosed with plantar fasciosis (in one or both of their feet) OR
• Patients meeting criteria of pain in the bottom of the foot/heel with first steps in the morning & tender to palpation over the medial calcaneal tubercle (where the plantar fascia inserts).

Those with acute and chronic diagnoses will be included.

Exclusion Criteria:

• Pregnant

• Any of the following in the foot being included into the study:

  • Active cellulitis of lower extremity
  • Prior surgery for plantar fasciosis
  • Steroid injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subjects will be offered to be involved in the study after they have completed a 12 -week wash out period.
  • If they have every had any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local Periosteal points, any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed a 12-week wash out period.
  • Botox injections for plantar fasciosis injections in the last 12 weeks for plantar fasciosis; if received in last 12 weeks subject will be offered to be involved in the study after they have completed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention + Standard of care; Acupuncture with electrostimulation plus standard of care prescribed home exercise program.	Device: Intervention + Standard of care; Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.
ACTIVE_COMPARATOR: Standard of care; Standard of care prescribed home exercise program.	Other: Standard of care; Standard of care prescribed home exercise program for treatment of plantar fasciosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used	visit 1 (Day 1)
Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used	visit 2 (week 2)
Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used	visit 3 (week 4)
Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used	visit 4 (week 6)
Defense and Veterans Pain Rating Scale (DVPRS)	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. It has been confirmed for reliability and validity in measuring both acute and chronic pain, and is currently the standard for pain measurement throughout DoD and VA health systems. The DVPRS has demonstrated linear scale qualities allowing parametric methods to be used	visit 5 (week 12)
Defense and Veterans Pain Rating Scale Supplemental Questions	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.	visit 1 (Day 1)
Defense and Veterans Pain Rating Scale Supplemental Questions	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.	visit 2 (week 2)
Defense and Veterans Pain Rating Scale Supplemental Questions	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.	visit 3 (week 4)
Defense and Veterans Pain Rating Scale Supplemental Questions	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. For clinicians to evaluate the biopsychosocial impact of pain.	visit 4 (week 6)
Defense and Veterans Pain Rating Scale Supplemental Questions	For clinicians to evaluate the biopsychosocial impact of pain.	The DVPRS consists of an 11-point numerical rating scale with 0 indicating no pain and 10 indicating severe pain. visit 5 (week 12)
Foot function index revised short (FFI-R short)	FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.	visit 1 (Day 1)
Foot function index revised short (FFI-R short)	FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.	visit 2 (week 2)
Foot function index revised short (FFI-R short)	FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.	visit 3 (week 4)
Foot function index revised short (FFI-R short)	FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.	visit 4 (week 6)
Foot function index revised short (FFI-R short)	FFI-R short uses a likert questionnaire to document foot pain severity, foot stiffness, difficulty performing activities, activity limitation, and social issues related to affected foot. It consists of 23 self-reported items divided into 3 subcategories on the basis of patient values: pain, disability and activity limitation.The patient has to score each question on a scale from 0 (no pain or difficulty) to 10 (worst pain imaginable or so difficult it requires help), that best describes their foot over the past week.	visit 5 (week 12)

Collaborators and Investigators

• Sponsor: brett rasmussen

Publications and helpful links

General Publications

• Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
• Cotchett MP, Landorf KB, Munteanu SE. Effectiveness of dry needling and injections of myofascial trigger points associated with plantar heel pain: a systematic review. J Foot Ankle Res. 2010 Sep 1;3:18. doi: 10.1186/1757-1146-3-18.
• Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.
• Glickman-Simon R, Wallace J. Acupuncture for knee osteoarthritis, chasteberry for premenstrual syndrome, probiotics for irritable bowel syndrome, yoga for hypertension, and trigger point dry needling for plantar fasciitis. Explore (NY). 2015 Mar-Apr;11(2):157-61. doi: 10.1016/j.explore.2014.12.009. Epub 2014 Dec 29. No abstract available.
• Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.
• Kumnerddee W, Pattapong N. Efficacy of electro-acupuncture in chronic plantar fasciitis: a randomized controlled trial. Am J Chin Med. 2012;40(6):1167-76. doi: 10.1142/S0192415X12500863.
• Landorf, K, J Radford, "Minimal important difference: Values for the Foot Health Status Questionnaire, Foot FunctionIndex and Visual Analogue Scale," The Foot. Mar 2008 18(1):15-19.
• Li S, Shen T, Liang Y, Zhang Y, Bai B. Miniscalpel-Needle versus Steroid Injection for Plantar Fasciitis: A Randomized Controlled Trial with a 12-Month Follow-Up. Evid Based Complement Alternat Med. 2014;2014:164714. doi: 10.1155/2014/164714. Epub 2014 Jul 8.
• Schwartz O, Levinson T, Astman N, Haim L. Attrition due to orthopedic reasons during combat training: rates, types of injuries, and comparison between infantry and noninfantry units. Mil Med. 2014 Aug;179(8):897-900. doi: 10.7205/MILMED-D-13-00567. Erratum In: Mil Med. 2016 Sep;181(9):1165. Mil Med. 2016 Oct;181(10 ):1391.
• Owens BD, Wolf JM, Seelig AD, Jacobson IG, Boyko EJ, Smith B, Ryan MA, Gackstetter GD, Smith TC; Millennium Cohort Study Team. Risk Factors for Lower Extremity Tendinopathies in Military Personnel. Orthop J Sports Med. 2013 Jun 11;1(1):2325967113492707. doi: 10.1177/2325967113492707. eCollection 2013 Jan-Jun.
• Roy TC. Diagnoses and mechanisms of musculoskeletal injuries in an infantry brigade combat team deployed to Afghanistan evaluated by the brigade physical therapist. Mil Med. 2011 Aug;176(8):903-8. doi: 10.7205/milmed-d-11-00006.
• 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.
• Thiagarajah AG. How effective is acupuncture for reducing pain due to plantar fasciitis? Singapore Med J. 2017 Feb;58(2):92-97. doi: 10.11622/smedj.2016143. Epub 2016 Aug 16.
• Woitzik E, Jacobs C, Wong JJ, Cote P, Shearer HM, Randhawa K, Sutton D, Southerst D, Varatharajan S, Brison RJ, Yu H, van der Velde G, Stern PJ, Taylor-Vaisey A, Stupar M, Mior S, Carroll LJ. The effectiveness of exercise on recovery and clinical outcomes of soft tissue injuries of the leg, ankle, and foot: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Man Ther. 2015 Oct;20(5):633-45. doi: 10.1016/j.math.2015.03.012. Epub 2015 Mar 28.
• Zhang SP, Yip TP, Li QS. Acupuncture treatment for plantar fasciitis: a randomized controlled trial with six months follow-up. Evid Based Complement Alternat Med. 2011;2011:154108. doi: 10.1093/ecam/nep186. Epub 2011 Feb 15.
• Polomano RC, Galloway KT, Kent ML, Brandon-Edwards H, Kwon KN, Morales C, Buckenmaier C' 3rd. Psychometric Testing of the Defense and Veterans Pain Rating Scale (DVPRS): A New Pain Scale for Military Population. Pain Med. 2016 Aug;17(8):1505-19. doi: 10.1093/pm/pnw105. Epub 2016 Jun 6.
• Nassif TH, Hull A, Holliday SB, Sullivan P, Sandbrink F. Concurrent Validity of the Defense and Veterans Pain Rating Scale in VA Outpatients. Pain Med. 2015 Nov;16(11):2152-61. doi: 10.1111/pme.12866. Epub 2015 Aug 8.
• Sloman R, Wruble AW, Rosen G, Rom M. Determination of clinically meaningful levels of pain reduction in patients experiencing acute postoperative pain. Pain Manag Nurs. 2006 Dec;7(4):153-8. doi: 10.1016/j.pmn.2006.09.001.
• Holm, S. 1979. A simple sequential rejective multiple test procedure. Scand. J. Statistics, 6: 65-70.
• R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2016 URL http://www.R-project.org/.

Helpful Links

• General Hospital and Personal Use Therapeutic Devices

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ACTUAL): November 2, 2021
• Study Completion (ACTUAL): November 2, 2021

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 24, 2020
• First Posted (ACTUAL): January 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2022
• Last Update Submitted That Met QC Criteria: January 13, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: primary care; acupuncture; electrostimulation; Plantar fasciosis
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: FWH20200060H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan on sharing data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No