ABI v Dry Needling for Plantar Fasciitis

University Hospitals, Leicester90 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Plantar Fasciitis

Interventions

Autologous Blood InjectionOTHER

ultrasound-guided autologous blood injection procedure

Structured rehabilitation programmeOTHER

(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 injectionOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Outcomes

Primary Outcomes

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

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

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

Time frame: 3 & 6 months

Data from ClinicalTrials.gov

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