ABI v Dry Needling for Plantar Fasciitis

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02546089
• Other study ID #: UHL - 11334
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 4, 2020

Study information

• Verified date: September 2020
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 4, 2020
• Est. primary completion date: September 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

Other:
• Autologous Blood Injection
ultrasound-guided autologous blood injection procedure
• 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
• dry needling injection
(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

Locations

Country	Name	City	State
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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