Acupuncture for Plantar Fasciosis in the Primary Care Setting

NCT03246087 | Completed Results FDA Device

• 1 other identifier: FWH20170077H
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to determine if the addition of acupuncture to a standard of care prescribed exercise program is more effective at improving pain and function in adult patients with plantar fasciosis.

Conditions

Plantar Fascitis

Keywords

acupuncture; plantar fasiosis

Outcome Measures

Primary Outcomes (1)

• NPRS-11

  Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain.

  90 days

Secondary Outcomes (1)

• FFI-R

  90 days

Study Arms (3)

Acupuncture

ACTIVE COMPARATOR

Patients will receive acupuncture for plantar fasciosis. The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.

Device: Acupunture

Standard of Care

EXPERIMENTAL

The standard of care home exercise program will be reviewed along with the stretching and strengthening exercises.

Other: Standard of care

Crossover

EXPERIMENTAL

At the end of the study, patients in the Standard of Care group whom are still experiencing pain and symptoms will be rolled into the acupuncture treatment arm of the study.

Device: Acupunture

Interventions

Acupunture DEVICE

acupuncture for plantar fasciosis Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.

Acupuncture; Crossover

Standard of care OTHER

standard of care home exercise program

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female DoD beneficiaries, age 18 years or older, who have been diagnosed with plantar fasciitis/fasciosis 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.

You may not qualify if:

• Pregnant
• Absence of leg
• Active cellulitis of lower extremity
• Prior surgery for plantar fasciitis
• Steroid injections in the last 12 weeks for plantar fasciitis; 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.
• Any regenerative therapy to include proliferation therapy or platelet rich plasma therapy in the last 12 weeks for plantar fasciitis; 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 fasciitis injections in the last 12 weeks for plantar fasciitis; 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.
• Use of anticoagulants
• If they have every had any prior acupuncture for plantar fasciitis using the defined KB-2 points

Sponsors & Collaborators

• Mike O'Callaghan Military Hospital: lead

Study Sites (2)

Scott AFB

Belleville, Illinois, 62225, United States

Location

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (12)

• 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.

  PMID: 20807448 BACKGROUND

• Covey CJ, Mulder MD. Plantar fasciitis: How best to treat? J Fam Pract. 2013 Sep;62(9):466-71.

  PMID: 24080555 BACKGROUND

• 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.

  PMID: 25682385 BACKGROUND

• 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.

  PMID: 23227789 BACKGROUND

• 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.

  PMID: 25114704 BACKGROUND

• 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.

  PMID: 25102533 BACKGROUND

• 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.

  PMID: 26535232 BACKGROUND

• 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.

  PMID: 21882780 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

• 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.

  PMID: 27526703 BACKGROUND

• 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.

  PMID: 25892707 BACKGROUND

• 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.

  PMID: 19933769 BACKGROUND

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Amanda Crawford
• Organization: MOMH

amanda.j.crawford.ctr@health.mil

7026533583

Study Officials

• Stephen Cagle, MD

  Scott AFB

  PRINCIPAL INVESTIGATOR

• Carlton Covey, MD

  Nellis AF

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: August 11, 2017
• Study Start: October 17, 2017
• Primary Completion: April 13, 2019
• Study Completion: April 13, 2019
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)