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Acupuncture for Plantar Fasciosis in the Primary Care Setting

Primary Purpose

Plantar Fascitis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Acupunture

Standard of care

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring acupuncture, plantar fasiosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY.

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

Scott AFB
Mike O'Callaghan Federal Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Acupuncture

Standard of Care

Crossover

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

NPRS-11

Numeric Pain Rating Scale

Secondary Outcome Measures

VAS

Visual Analogue Scale

FFI-R

Revised Foot Function Index Short Form

Full Information

NCT ID

NCT03246087

First Posted

July 14, 2017

Last Updated

March 5, 2019

Sponsor

Mike O'Callaghan Military Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03246087

Brief Title

Acupuncture for Plantar Fasciosis in the Primary Care Setting

Official Title

Acupuncture for Plantar Fasciosis in the Primary Care Setting

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 17, 2017 (Actual)

Primary Completion Date

February 13, 2019 (Actual)

Study Completion Date

February 13, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mike O'Callaghan Military Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Investigators are studying whether a specific acupuncture protocol, when added to the standard of care treatment, can improve pain and function in adults with plantar fasciosis. 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. Investigators will measure foot pain immediately prior to treatment (baseline), immediately after the initial treatment and at 2 weeks, 4 weeks, and 3 months. The Foot Function Index Revised short form will be used during the same intervals to evaluate foot function. At 3 months, patients in the non-acupuncture group will cross-over into the acupuncture group if still experiencing pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Plantar Fascitis

Keywords

acupuncture, plantar fasiosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Acupuncture

Arm Type

Active Comparator

Arm Description

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

Arm Title

Standard of Care

Arm Type

Experimental

Arm Description

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

Arm Title

Crossover

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

Acupunture

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard of care

Intervention Description

standard of care home exercise program

Primary Outcome Measure Information:

Title

NPRS-11

Description

Numeric Pain Rating Scale

Time Frame

90 days

Secondary Outcome Measure Information:

Title

VAS

Description

Visual Analogue Scale

Time Frame

90 days

Title

FFI-R

Description

Revised Foot Function Index Short Form

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

THIS STUDY IS BEING CONDUCTED AT A MILITARY INSTALLATION. YOU MUST HAVE MILITARY INSURANCE IN ORDER TO PARTICIPATE IN THIS STUDY. Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephen Cagle, MD

Organizational Affiliation

Scott AFB

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Carlton Covey, MD

Organizational Affiliation

Nellis AF

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scott AFB

City

Belleville

State/Province

Illinois

ZIP/Postal Code

62225

Country

United States

Facility Name

Mike O'Callaghan Federal Hospital

City

Nellis Air Force Base

State/Province

Nevada

ZIP/Postal Code

89191

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

20807448

Citation

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.

Results Reference

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PubMed Identifier

24080555

Citation

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

Results Reference

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PubMed Identifier

25682385

Citation

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.

Results Reference

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

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PubMed Identifier

25102533

Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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Citation

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.

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PubMed Identifier

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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.

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Citation

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Citation

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.

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Acupuncture for Plantar Fasciosis in the Primary Care Setting

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