ABI v Dry Needling for Plantar Fasciitis

NCT ID: NCT02546089

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2020-09-04

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.

Detailed Description

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Conditions

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Plantar Fasciitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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intervention group

local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,

\+ structured rehab programme

Group Type ACTIVE_COMPARATOR

Autologous Blood Injection

Intervention Type OTHER

ultrasound-guided autologous blood injection procedure

Structured rehabilitation programme

Intervention Type OTHER

(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

Intervention Type OTHER

(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

control group

local anaesthetic - lidocaine 1%, dry needling,

\+ structured rehab programme

Group Type PLACEBO_COMPARATOR

Structured rehabilitation programme

Intervention Type OTHER

(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

Intervention Type OTHER

(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

Interventions

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Autologous Blood Injection

ultrasound-guided autologous blood injection procedure

Intervention Type OTHER

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

Intervention Type OTHER

dry needling injection

(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals, Leicester

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patrick Wheeler

Role: PRINCIPAL_INVESTIGATOR

UHL NHS Trust

Locations

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University Hospitals of Leicester NHS Trust

Leicester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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UHL - 11334

Identifier Type: -

Identifier Source: org_study_id

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