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Plantar Fasciitis, ChronicNCT07827638

Radial vs Focused Shockwave Therapy for Plantar Fasciitis

A study testing Focused Shockwave therapy and Radial shockwave therapy in people with Plantar Fasciitis, Chronic, run by Homerton University Hospital NHS Foundation Trust.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn whether focused extracorporeal shockwave therapy (ESWT) provides better outcomes than radial ESWT for adults with plantar fasciitis. It will also learn about the safety and tolerability of both treatments. The main questions it aims to answer are: 1. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Plantar Fasciitis, Chronic
What is being tested?
Focused Shockwave therapy and Radial shockwave therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
No sites listed yet
Study dates
Nov 2026to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 18 years or older; 2. chronic plantar heel pain for at least 3 months; 3. clinical presentation consistent with plantar fasciitis / plantar fasciopathy; 4. baseline average heel pain of at least 4/10 in at least one heel proposed for study treatment; 5. imaging findings supportive of plantar fasciitis / plantar fasciopathy on either:
  • ultrasound scan (USS); or
  • magnetic resonance imaging (MRI); 6. able to understand the study and provide written informed consent; 7. sufficient spoken and written English to understand the study information and complete the planned questionnaires and telephone follow-up assessments

Who cannot join

  • Participants will be excluded for any of the following:
  • previous ESWT to the affected study foot;
  • corticosteroid injection to the affected region within the preceding 3 months;
  • previous plantar fascia surgery;
  • an alternative diagnosis considered to be the principal cause of the heel pain;
  • current or suspected calcaneal or other relevant stress fracture;
Show all 12Show fewer
  • relevant inflammatory arthropathy;
  • pregnancy;
  • recognised contraindication to ESWT;
  • inability to provide informed consent;
  • insufficient spoken or written English to understand the study information or complete the planned study procedures where appropriately translated materials and interpreter-supported longitudinal follow-up are unavailable;
  • any other clinical factor considered by the investigator to make participation inappropriate or unsafe

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

DR Mukhey contact

020 8510 5555

dev.mukhey@nhs.net

About this study

Official title: A Randomised Controlled Trial Comparing Radial Versus Focused Extracorporeal Shockwave Therapy for Chronic Plantar Fasciitis

The goal of this clinical trial is to learn whether focused extracorporeal shockwave therapy (ESWT) provides better outcomes than radial ESWT for adults with plantar fasciitis. It will also learn about the safety and tolerability of both treatments.

The main questions it aims to answer are:

Read more
  1. Does focused ESWT lead to greater improvement in heel pain than radial ESWT?
  2. Does focused ESWT improve foot function more than radial ESWT?
  3. Do participants experience less discomfort during focused ESWT compared with radial ESWT?
  4. What medical problems or side effects occur with either treatment?

Researchers will compare focused ESWT to radial ESWT to see whether one treatment offers better clinical outcomes or is better tolerated.

Participants will:

  1. Receive three shockwave treatment sessions (radial or focused), one week apart
  2. Attend clinic follow-up assessments at 6 weeks, 12 weeks, 6 months, and 12 months
  3. Complete questionnaires about heel pain and foot function Keep a diary of symptoms, daily pain levels, activity limitations, and any use of pain medication
Being tested
Focused Shockwave therapy, Radial shockwave therapy
Medical subject headings
Fasciitis, Plantar

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Focused Shockwave therapyDevice

    Patients will be randomly allocated to focused shockwave therapy in clusters. The settings with regards to the waves will be pre-determined and will be the normal setting usually used by the department They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.

  • Radial shockwave therapyDevice

    Patients will be randomly allocated to radial shockwave therapy in clusters The setting for the shockwave will be pre-determined as advised by the literature and manufacturers of the device They will have one session every week for 3 weeks We will chase them up with outcome at 6 weeks, 12 weeks, 6 months and 12months.

Study groups in NCT07827638
Study groupRoleWhat they receive
Random allocation to focused ESWTActive comparatorNot described
Receives: Device: Focused Shockwave therapy
Random allocation to radial ESWTActive comparatorNot described
Receives: Device: Radial shockwave therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10

    To compare the clinical effectiveness of radial versus focused Extracorporeal shockwave therapy (ESWT) for chronic plantar heel pain by assessing the difference between treatment groups in average heel pain at 12 weeks, adjusted for baseline pain.

    The numerical rating scale ranges from 0 - 10 with 10 being a worse outcome

    Measured: 12 weeks

Secondary outcomes (7)

  1. To compare the effect of radial and focused shockwave therapy on foot related function using the modified Foot Function Index (FFI) questionnaire

    The modified foot function index is a 23 item questionnaire with a 0 - 10 numerical scale response. Higher scoring tends to indicate worse outcome.

    This questionnaire will be done at baseline, 6 weeks, 12 weeks, 6 months and 12 months

    Measured: 12 months

  2. Comparing first step heel pain after radial vs focused shockwave therpay using a numerical rating scale from 0 - 10

    This will be recorded at baseline, 6 weeks, 12 weeks, 6 months and 12 months. A higher score indicates a worse outcome

    Measured: 12 months

  3. To compare procedural treatment discomfort after radial vs focused shockwave therapy using a numerical rating scale (ranging 0-10)

    This will be recorded after each treatment session. There are 3 treatment session in total happening in 3 consecutive weeks, once a week A higher score indicates a worse outcome

    Measured: 3 weeks

  4. Patient-reported global improvement following radial vs focused shockwave therapy using a Likert scale

    This will be recorded at 6 weeks, 12 weeks, 6 months and 12 months.

    The likert scale is as follows:

    Compared with before shockwave treatment, how is your heel pain now? Much worse Worse no change Better Much better

    Measured: 12 months

  5. To compare patient satisfaction after undergoing radial vs shockwave therapy using a likert scale

    Patient satisfaction will be recorded at 12 weeks, 6 months and 12months using a Likert scale in the following format How satisfied are you in the outcome of your treatment? Very dissatisfied Dissatisfied Neutral satisfied Very satisfied

    Measured: 12 months

  6. To compare willingness to undergo the same treatment after undergoing radial vs shockwave therapy using a qualitative question

    This will be recorded at baseline 12 weeks, 6 months and 12 months using the following template; If you were int he same situation again, would you choose to have this treatment Yes No Unsure

    Measured: 12 months

  7. Comparing treatment related adverse events after radial vs focused shockwave therapy using a qualitative question

    This will be recorded at 6 weeks, 12 weeks, 6 months and 12 months. The question template is as follows; Adverse event since the previous study contact None Bruising New neurological symptoms Pain flare lasting >48hours Skin irritation Others (please elaborate)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2026
  2. Study startNov 2026 (estimated)
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

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
Model description
This is a: * prospective; * single-centre; * two-arm; * parallel-group; * 1:1 cluster-randomised; * assessor-blinded; * superiority randomised controlled trial The clinic treatment cohort/list is the unit of randomisation. Each cohort is a scheduled shockwave clinic list under one treating clinician and may contain up to approximately 9 clinical patients. Based on the current service mix, about 80% are expected to have plantar fasciitis / chronic plantar heel pain, giving an anticipated mean of approximately 7.2 potentially eligible study patients per cohort. The same clinic cohort returns for the full course of three weekly ESWT sessions and receives the same allocated modality at all three sessions. Each clinic treatment cohort/list will be allocated to: Group A - Radial extracorporeal shockwave therapy or Group B - Focused extracorporeal shockwave therapy
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07827638
Sponsor's protocol ID
IRAS project number: 375776
Status last verified
Oct 2026
First submitted
9 Sep 2026
Last updated
29 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Focused Shockwave therapy and Radial shockwave therapy in people with Plantar Fasciitis, Chronic, run by Homerton University Hospital NHS Foundation Trust.

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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact DR Mukhey (020 8510 5555, dev.mukhey@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Heel pain at 12 weeks using a numerical rating scale ranging from 0 - 10 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07827638.

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 29 Oct 2026.

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