Study Results
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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COMPLETED
NA
90 participants
INTERVENTIONAL
2014-10-31
2020-09-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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intervention group
local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
\+ structured rehab programme
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
control group
local anaesthetic - lidocaine 1%, dry needling,
\+ structured rehab programme
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
120 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Responsible Party
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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
Countries
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Other Identifiers
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UHL - 11334
Identifier Type: -
Identifier Source: org_study_id
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