ABI v Dry Needling for Plantar Fasciitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Other: Autologous Blood Injection
* Other: Structured rehabilitation programme
* Other: dry needling injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |