Investigating the Effects of Ultrasound Guided Autologous Blood Injection for Chronic Plantar Fasciitis Versus Ultrasound Guided Dry-needling Alone, a Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Reduction in pain - as assessed by 0-10 VAS scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 120 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
Intervention: Autologous Blood Injection (Other)
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
Intervention: Structured rehabilitation programme (Other)
intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
- structured rehab programme
Intervention: dry needling injection (Other)
control group
local anaesthetic - lidocaine 1%, dry needling,
- structured rehab programme
Intervention: Structured rehabilitation programme (Other)
control group
local anaesthetic - lidocaine 1%, dry needling,
- structured rehab programme
Intervention: dry needling injection (Other)
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)(3 & 6 months)