Skip to main content
OpenTrials
Completed

NCT Number: NCT03246087

Acupuncture for Plantar Fasciosis in the Primary Care Setting

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Plantar Fascitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scott AFB, Belleville, Illinois, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupunture

Device

acupuncture for plantar fasciosis

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

Standard of care

Other

standard of care home exercise program

Primary outcomes

  1. NPRS-11

    Time frame: 90 days

    Numeric Pain Rating Scale. 11 point numeric rating on a scale of 0-10 to measure pain intensity. 0 being no pain, 5 being moderate pain, and 10 being worst pain.

Secondary outcomes

  1. FFI-R

    Time frame: 90 days

    Revised Foot Function Index Short Form. FFI-R measures the impact of foot pathology on function for 5 subscales of: pain (7 questions), stiffness (7 questions), difficulty (11 questions), activity limitation (3 questions), social issues (6 questions).

    Each question ranges from 1 (no pain/no stiffness/no difficulty/none of the time) to 4 (severe pain/stiffness/difficulty/all of the time).

    Subscale scores are added up to a total cumulative score. Minimum total score (least pain/stiffness/difficulty) is 34. Maximum total score (most pain/stiffness/difficulty) is 136.

Sponsors and collaborators

Lead sponsor

Mike O'Callaghan Military Hospital

Fed

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 11, 2017
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.