Plantar FasciitisNCT02546089
ABI v Dry Needling for Plantar Fasciitis
A study testing Autologous Blood Injection, Structured rehabilitation programme and dry needling injection in people with Plantar Fasciitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Autologous Blood Injection, Structured rehabilitation programme and dry needling injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to 4 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 …
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals of Leicester NHS Trust
Leicester
About this study
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
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.
- Conditions
- Plantar Fasciitis
- Being tested
- Autologous Blood Injection, Structured rehabilitation programme, dry needling injection
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Blood InjectionOther
ultrasound-guided autologous blood injection procedure
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
dry needling injectionOther
(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Active comparator | local anaesthetic - lidocaine 1%, dry needling, autologous blood injection,
+ structured rehab programme Receives: Other: Autologous Blood Injection; Other: Structured rehabilitation programme; Other: dry needling injection |
| control group | Placebo comparator | local anaesthetic - lidocaine 1%, dry needling,
+ structured rehab programme Receives: Other: Structured rehabilitation programme; Other: dry needling injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in pain - as assessed by 0-10 VAS scale
Measured: 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)
validated PROMs in use in this study include: FFI-r, MOXFQ, FAAM
Measured: 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startOct 2014
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Wheeler, Principal investigator, UHL NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02546089
- Sponsor's protocol ID
- UHL - 11334
- Status last verified
- Sep 2020
- First submitted
- 15 Jun 2015
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02546089
- Acronym / sponsor ID
- UHL - 11334
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 10 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Active comparator | Other: Autologous Blood Injection, Other: Structured rehabilitation programme, Other: dry needling injectionlocal anaesthetic - lidocaine 1%, dry needling, autologous blood injection, + structured rehab programme |
| control group | Placebo comparator | Other: Structured rehabilitation programme, Other: dry needling injectionlocal anaesthetic - lidocaine 1%, dry needling, + structured rehab programme |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 …
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Blood Injectionultrasound-guided autologous blood injection procedure | Other | intervention group |
| 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 | Other | control group, intervention group |
| dry needling injection(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance | Other | control group, intervention group |
Primary outcome
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
1 secondary outcome
Reduction in pain / improvement in function - as assessed by several PROMS (as below)
Time frame: 3 & 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Wheeler principal investigator
UHL NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Blood Injection, Structured rehabilitation programme and dry needling injection in people with Plantar Fasciitis, run by University Hospitals, Leicester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.