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ABI v Dry Needling for Plantar Fasciitis

Primary Purpose

Plantar Fasciitis

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Autologous Blood Injection
Structured rehabilitation programme
dry needling injection
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fasciitis

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospitals of Leicester NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

intervention group

control group

Arm Description

local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme

local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme

Outcomes

Primary Outcome Measures

Reduction in pain - as assessed by 0-10 VAS scale

Secondary Outcome Measures

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

Full Information

First Posted
June 15, 2015
Last Updated
September 7, 2020
Sponsor
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT02546089
Brief Title
ABI v Dry Needling for Plantar Fasciitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
October 2014 (Actual)
Primary Completion Date
September 4, 2020 (Actual)
Study Completion Date
September 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fasciitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Active Comparator
Arm Description
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
local anaesthetic - lidocaine 1%, dry needling, + structured rehab programme
Intervention Type
Other
Intervention Name(s)
Autologous Blood Injection
Intervention Description
ultrasound-guided autologous blood injection procedure
Intervention Type
Other
Intervention Name(s)
Structured rehabilitation programme
Intervention Description
(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
Intervention Type
Other
Intervention Name(s)
dry needling injection
Intervention Description
(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Reduction in pain / improvement in function - as assessed by several PROMS (as below)
Description
validated PROMs in use in this study include: FFI-r, MOXFQ, FAAM
Time Frame
3 & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Wheeler
Organizational Affiliation
UHL NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Leicester NHS Trust
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

ABI v Dry Needling for Plantar Fasciitis

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