ABI v Dry Needling for Plantar Fasciitis

Not Applicable

Completed

• Conditions: Plantar Fasciitis
• Interventions: Other: Autologous Blood Injection; Other: Structured rehabilitation programme; Other: dry needling injection

• Registration Number: NCT02546089
• Lead Sponsor: University Hospitals, Leicester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-09-07
• Study First Posted: 2015-09-10
• Status Verified: 2020-09
• Primary Completion: 2020-09-04
• Study Completion: 2020-09-04
• Last Update Submitted: 2020-09-07
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Structured rehabilitation programme	local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme
intervention group	Autologous Blood Injection	local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme
intervention group	dry needling injection	local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme
control group	Structured rehabilitation programme	local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme
control group	dry needling injection	local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, United Kingdom