Radial vs Focused Shockwave Therapy for Plantar Fasciitis

NCT07827638 | Not Yet Recruiting

• 1 other identifier: IRAS project number: 375776
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.Does focused ESWT lead to greater improvement in heel pain than radial ESWT?
2. 2.Does focused ESWT improve foot function more than radial ESWT?
3. 3.Do participants experience less discomfort during focused ESWT compared with radial ESWT?
4. 4.What medical problems or side effects occur with either treatment?
5. 5.Receive three shockwave treatment sessions (radial or focused), one week apart
6. 6.Attend clinic follow-up assessments at 6 weeks, 12 weeks, 6 months, and 12 months
7. 7.Complete questionnaires about heel pain and foot function Keep a diary of symptoms, daily pain levels, activity limitations, and any use of pain medication

Conditions

Plantar Fasciitis, Chronic

Outcome Measures

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

  12 weeks

Secondary Outcomes (7)

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

  12 months

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

  12 months

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

  3 weeks

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

  12 months

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

  12 months

Study Arms (2)

Random allocation to focused ESWT

ACTIVE COMPARATOR

Device: Focused Shockwave therapy

Random allocation to radial ESWT

ACTIVE COMPARATOR

Device: Radial shockwave therapy

Interventions

Focused Shockwave therapy DEVICE

Patients will be randomly allocated to focused shockwave therapy. 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.

Random allocation to focused ESWT

Radial shockwave therapy DEVICE

Patients will be randomly allocated to radial shockwave therapy 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.

Random allocation to radial ESWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Homerton University Hospital NHS Foundation Trust: lead

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Central Study Contacts

DR Mukhey

CONTACT

020 8510 5555; dev.mukhey@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Dev Mukhey (Sports and Exercise medicine Doctor) - Principal Investigator

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share