ABI v Dry Needling for Plantar Fasciitis

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02546089

Enrollment

Registered

2015-09-10

Start date

2014-10-31

Completion date

2020-09-04

Last updated

2020-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plantar Fasciitis

Brief summary

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.

Interventions

OTHERAutologous Blood Injection

ultrasound-guided autologous blood injection procedure

OTHERStructured rehabilitation programme

(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

OTHERdry needling injection

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

Inclusion criteria

1. 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 2. Failure of previous conservative therapy - including physiotherapy, and podiatry input 3. Objective evidence of plantar fasciitis - either ultrasound or MRI investigations 4. No contraindications of injection therapy - anticoagulation, blood borne illness, strong needle phobia …

Exclusion criteria

1. Patients with either partial or full-thickness tears of plantar fascia found on investigations 2. Subjects who are unable to give valid consent for study entry based on normal competency assessment 3. Subjects unable or unwilling to undergo the rehabilitation plan post-procedure 4. Subjects unable or unwilling to attend the follow-up appointments post-procedure

Design outcomes

Primary

Measure	Time frame
Reduction in pain - as assessed by 0-10 VAS scale	3 & 6 months - primary outcome set at 6 months for study, but using 3 month interim result as well

Secondary

Measure	Time frame	Description
Reduction in pain / improvement in function - as assessed by several PROMS (as below)	3 & 6 months	validated PROMs in use in this study include: FFI-r, MOXFQ, FAAM

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026