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OpenTrials
Completed

NCT Number: NCT02546089

ABI v Dry Needling for Plantar Fasciitis

To investigate whether a procedure of ultrasound-guided autologous blood injections (ABI), which includes a dry-needling component within the overall procedure, has any measureable clinical benefit over ultrasound-guided dry needling alone in patients with chronic plantar fasciitis.

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Key information

Conditions

Plantar Fasciitis Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18 or over who are being seen in the Department of Sports Medicine (all of whom are age 16 or over) with chronic plantar fasciitis of at least 6 months duration
  • Failure of previous conservative therapy - including physiotherapy, and podiatry input
  • Objective evidence of plantar fasciitis - either ultrasound or MRI investigations
  • No contraindications of injection therapy - anticoagulation, blood borne illness, strong needle phobia …

Exclusion criteria

  • Patients with either partial or full-thickness tears of plantar fascia found on investigations
  • Subjects who are unable to give valid consent for study entry based on normal competency assessment
  • Subjects unable or unwilling to undergo the rehabilitation plan post-procedure
  • Subjects unable or unwilling to attend the follow-up appointments post-procedure

Treatment and study plan

Autologous Blood Injection

Other

ultrasound-guided autologous blood injection procedure

Structured rehabilitation programme

Other

(this intervention is given to patients in both arms of the study) - a standardised structured rehabilitation programme of home exercises that the patient is instructed on how to start, and how to progress during the study period

dry needling injection

Other

(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

Primary outcomes

  1. Reduction in pain - as assessed by 0-10 VAS scale

    Time frame: 3 & 6 months - primary outcome set at 6 months for study, but using 3 month interim result as well

Secondary outcomes

  1. Reduction in pain / improvement in function - as assessed by several PROMS (as below)

    Time frame: 3 & 6 months

    validated PROMs in use in this study include: FFI-r, MOXFQ, FAAM

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University Hospitals, Leicester

Other

Registry information

Official study title

Investigating the Effects of Ultrasound Guided Autologous Blood Injection for Chronic Plantar Fasciitis Versus Ultrasound Guided Dry-needling Alone, a Randomised Controlled Trial

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2015
Registry last updated
Sep 9, 2020

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.

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