NCT02546089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 10, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2020

Completed
Last Updated

September 9, 2020

Status Verified

September 1, 2020

Enrollment Period

5.9 years

First QC Date

June 15, 2015

Last Update Submit

September 7, 2020

Conditions

Plantar Fasciitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Reduction in pain / improvement in function - as assessed by several PROMS (as below)

    3 & 6 months

Study Arms (2)

intervention group

ACTIVE COMPARATOR

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

Other: Autologous Blood InjectionOther: Structured rehabilitation programmeOther: dry needling injection

control group

PLACEBO COMPARATOR

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

Other: Structured rehabilitation programmeOther: dry needling injection

Interventions

Autologous Blood InjectionOTHER

ultrasound-guided autologous blood injection procedure

intervention group
Structured rehabilitation programmeOTHER

(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

control groupintervention group
dry needling injectionOTHER

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

control groupintervention group

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 …

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Patrick Wheeler

    UHL NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2015

First Posted

September 10, 2015

Study Start

October 1, 2014

Primary Completion

September 4, 2020

Study Completion

September 4, 2020

Last Updated

September 9, 2020

Record last verified: 2020-09

Locations

GB(1)