ClinicalTrials.gg
Not yet recruitingNCT07827638Updated Oct 29, 2026

Radial vs Focused Shockwave Therapy for Plantar Fasciitis

An interventional study of Focused Shockwave therapy and Radial shockwave therapy in Plantar Fasciitis, Chronic, sponsored by Homerton University Hospital NHS Foundation Trust. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Homerton University Hospital NHS Foundation Trust · Not applicable, Interventional, and Treatment

Updated Oct 29, 2026Start date movedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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
02

Conditions studied

  • Plantar Fasciitis, Chronic

Browse trials for

03

In context

Fasciitis, Plantar

223 studies on the registry are indexed under Fasciitis, Plantar; 58 are open to participants now.

This study's planned enrollment of 216 is above the median of 56 across 194 interventional studies indexed under Fasciitis, Plantar.

Browse Fasciitis, Plantar studies →

Lead sponsor

Homerton University Hospital NHS Foundation Trust is the lead sponsor of 7 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 ; 7. sufficient spoken and written English to understand the study information and complete the planned questionnaires and telephone follow-up assessments

Exclusion criteria

Exclusion Criteria:

  • Participants will be excluded for any of the following:

    1. previous ESWT to the affected study foot;
    2. injection to the affected region within the preceding 3 months;
    3. previous plantar fascia surgery;
    4. an alternative diagnosis considered to be the principal cause of the heel pain;
    5. current or suspected calcaneal or other relevant stress fracture;
    6. relevant inflammatory arthropathy;
    7. pregnancy;
    8. recognised to ESWT;
    9. inability to provide ;
    10. 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;
    11. any other clinical factor considered by the investigator to make participation inappropriate or unsafe
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
216 participants (estimated)

Study arms

  • Active comparator
    Random allocation to focused ESWT

    Device: Focused Shockwave therapy

  • Active comparator
    Random allocation to radial ESWT

    Device: Radial shockwave therapy

Interventions

  • DeviceFocused Shockwave therapy

    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.

  • DeviceRadial shockwave therapy

    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.

06

What researchers measure

Primary outcomes

  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

    Time frame: 12 weeks

Secondary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Start date
Sep 2026→Nov 2026
Oct 29, 2026
Primary completion
Sep 2027→Nov 2027
Oct 29, 2026
Study completion
Sep 2027→Nov 2027
Oct 29, 2026
Enrollment
150→216
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Start date Sep 2026→Nov 2026
    Primary completion Sep 2027→Nov 2027
    Study completion Sep 2027→Nov 2027
    Enrollment 150→216
    + 3 other changes: verification date, design details and arm descriptions

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07827638
Lead sponsor
Homerton University Hospital NHS Foundation Trust
Responsible party
Titi Jempeji (Dr Dev Mukhey (Sports and Exercise medicine Doctor) - Principal Investigator, Homerton University Hospital NHS Foundation Trust) — Principal investigator
First posted
Sep 18, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

DR Mukhey
Contact
dev.mukhey@nhs.net
020 8510 5555

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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