Clinical trial NCT03246087: Acupuncture for Plantar Fasciosis in the Primary Care Setting
Official title: Acupuncture for Plantar Fasciosis in the Primary Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: acupuncture
plantar fasiosis
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2017-08-11
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: NPRS-11
timeFrame: 90 days
Secondary outcomes:
measure: FFI-R
timeFrame: 90 days
Other outcomes:
Locations:
city: Belleville
country: United States
facility: Scott AFB
state: Illinois
city: Nellis Air Force Base
country: United States
facility: Mike O'Callaghan Federal Hospital
state: Nevada
Study officials:
affiliation: Scott AFB
name: Stephen Cagle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nellis AF
name: Carlton Covey, MD
role: PRINCIPAL_INVESTIGATOR
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