Acupuncture for Plantar Fasciosis in the Primary Care Setting

NCT ID: NCT03246087

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2019-04-13

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.

Conditions

Plantar Fascitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acupuncture

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

Group Type: ACTIVE_COMPARATOR

Acupunture

Intervention Type: DEVICE

acupuncture for plantar fasciosis

Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.

Standard of Care

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

Group Type: EXPERIMENTAL

Standard of care

Intervention Type: OTHER

standard of care home exercise program

Crossover

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.

Group Type: EXPERIMENTAL

Acupunture

Intervention Type: DEVICE

acupuncture for plantar fasciosis

Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.

Interventions

Acupunture

acupuncture for plantar fasciosis

Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed.

Intervention Type: DEVICE

Standard of care

standard of care home exercise program

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mike O'Callaghan Military Hospital

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Cagle, MD

Role: PRINCIPAL_INVESTIGATOR

Scott AFB

Carlton Covey, MD

Role: PRINCIPAL_INVESTIGATOR

Nellis AF

Locations

Scott AFB

Belleville, Illinois, United States

Mike O'Callaghan Federal Hospital

Nellis Air Force Base, Nevada, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 20807448 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

FWH20170077H

Identifier Type: -

Identifier Source: org_study_id