Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

NCT ID: NCT04243343

Last Updated: 2022-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-11-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Plantar Fascitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention + Standard of care

Acupuncture with electrostimulation plus standard of care prescribed home exercise program.

Group Type EXPERIMENTAL

Intervention + Standard of care

Intervention Type DEVICE

Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.

Standard of care

Standard of care prescribed home exercise program.

Group Type ACTIVE_COMPARATOR

Standard of care

Intervention Type OTHER

Standard of care prescribed home exercise program for treatment of plantar fasciosis.

Interventions

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Intervention + Standard of care

Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.

Intervention Type DEVICE

Standard of care

Standard of care prescribed home exercise program for treatment of plantar fasciosis.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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brett rasmussen

FED

Sponsor Role lead

Responsible Party

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brett rasmussen

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paul F Crawford, MD

Role: STUDY_DIRECTOR

United States Air Force

Locations

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96th Medical Group

Eglin Air Force Base, Florida, United States

Site Status

Scott AFB

Belleville, Illinois, United States

Site Status

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20807448 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 24080555 (View on PubMed)

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.

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Goff JD, Crawford R. Diagnosis and treatment of plantar fasciitis. Am Fam Physician. 2011 Sep 15;84(6):676-82.

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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.

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Landorf KB, Twyford GN, Cotchett MP, Whittaker GA. Revised minimal important difference values for the visual analogue scale and Foot Health Status Questionnaire when used for plantar heel pain. J Foot Ankle Res. 2024 Dec;17(4):e70021. doi: 10.1002/jfa2.70021.

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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.

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Provided Documents

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Document Type: Informed Consent Form

View Document

Related Links

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Other Identifiers

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FWH20200060H

Identifier Type: -

Identifier Source: org_study_id

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