Specific Acupuncture Protocol for the Treatment of Plantar Fasciosis

brett rasmussen

Status: Completed

Conditions: Plantar Fascitis

Treatments: Device: Intervention + Standard of care; Other: Standard of care

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04243343

FWH20200060H

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

**Patients must be able to get care at Nellis Air Force Base, Scott Air Force Base, or Eglin Air Force Base (a military installation) in order to participate in this study**

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

Intervention + Standard of care

Experimental group

Description:

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

Treatment:

Device: Intervention + Standard of care

Standard of care

Active Comparator group

Description:

Standard of care prescribed home exercise program.

Treatment:

Other: Standard of care