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

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 Overview

• Status: Completed
• Conditions: Plantar Fasciitis
• Intervention / Treatment: Other: Autologous Blood Injection; Other: Structured rehabilitation programme; Other: dry needling injection

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leicester, United Kingdom
    • University Hospitals Of Leicester Nhs Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: intervention group; local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme	Other: Autologous Blood Injection; ultrasound-guided autologous blood injection procedure; Other: Structured 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; Other: dry needling injection; (this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance
PLACEBO_COMPARATOR: control group; local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme	Other: Structured 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; Other: dry needling injection; (this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 & 6 months

Collaborators and Investigators

• Sponsor: University Hospitals, Leicester

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2014
• Primary Completion (ACTUAL): September 4, 2020
• Study Completion (ACTUAL): September 4, 2020

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: September 7, 2015
• First Posted (ESTIMATE): September 10, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 7, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: UHL - 11334