Chronic Plantar FasciitisNCT06737445
Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis:
A study testing Radiofrequency ablation alone, Cortisone Injection and Extracorporeal shock wave therapy in people with Chronic Plantar Fasciitis, run by Kars Harakani State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Plantar Fasciitis
- What is being tested?
- Radiofrequency ablation alone, Cortisone Injection and Extracorporeal shock wave therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Feb 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Persistant heel pain for ≥ 6 months
- No response to at least 6 weeks of conservative treatment (including at least two of the following: NSAIDs, stretching exercises, ice, heel pads, physical therapy, or night splints)
- Age ≥ 18
- BMI ≤ 35
- VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity
- Willingness to participate in the study
Who cannot join
- Previous foot or ankle surgery, major trauma
- Tumor, osteomyelitis, or complex regional pain syndrome in the affected limb
- Allergy to local anesthesia or NSAIDs
- Pregnancy or breastfeeding
- History of calcaneal fracture
- Previous cortisone injection, ESWT, or RTL for similar complaints
Show all 17Show fewer
- BMI >35
- Age < 18
- Use of medications for neuropathic pain (Pregabalin, Gabapentin)
- Proximal nerve lesion (e.g., spinal stenosis, sciatica, tarsal tunnel syndrome)
- Regional skin or subcutaneous infections, fat pad atrophy
- History of rheumatic disease, or hematologic conditions
- History of peripheral vascular disease
- Seronegative arthropathies, heart failure, hepatic or metabolic disorders
- Pacemaker
- History of clubfoot, pes cavus, or calcaneovalgus
- Diabetic neuropathy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kars Harakani State Hospital
Kars, Merkez, 36000
About this study
Official title: Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: A Prospective Randomized Controlled Trial
Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal lesioning (RTL) in the management of chronic plantar fasciitis.
Read the detailed description
Based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of CSI, ESWT and RTL for recalcitrant plantar fasciitis. In this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.
- Conditions
- Chronic Plantar Fasciitis
- Being tested
- Radiofrequency ablation alone, Cortisone Injection, Extracorporeal shock wave therapy
- Keywords
- extracorporeal shock wave therapy (ESWT), radiofrequency thermal lesioning (RTL), Chronic plantar fasciitis, corticosteroid injection (CSI)
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation aloneProcedure or surgery
RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England).
Cortisone InjectionProcedure or surgery
An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed.
Extracorporeal shock wave therapyOther
Patients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA).
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency thermal lesioning (RTL) | Active comparator | RTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England). Receives: Procedure: Radiofrequency ablation alone |
| Extracorporeal shock wave therapy (ESWT) | Active comparator | Patients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA). Receives: Other: Extracorporeal shock wave therapy |
| Corticosteroid Injection | Active comparator | An injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed. Receives: Procedure: Cortisone Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) scores
Pain score (1 to 10 points)
Measured: 1st month. 3rd month, 6th month
Foot Function Index (FFI)
Function score (The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.)
Measured: 1st month. 3rd month, 6th month,
Roles and Maudsley Score
The Roles and Maudsley score is an established subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pretreatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pretreatment)
Measured: 1st month. 3rd month, 6th month,
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Apr 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars Harakani State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erdem Sahin, Kars Harakani State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737445
- Sponsor's protocol ID
- 27093
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erden T, Toker B, Cengiz O, Ince B, Asci S, Toprak A. Outcome of Corticosteroid Injections, Extracorporeal Shock Wave Therapy, and Radiofrequency Thermal Lesioning for Chronic Plantar Fasciitis. Foot Ankle Int. 2021 Jan;42(1):69-75. doi: 10.1177/1071100720949469. Epub 2020 Sep 3.
PubMed 32880199Liden B, Simmons M, Landsman AS. A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis. J Foot Ankle Surg. 2009 Nov-Dec;48(6):642-7. doi: 10.1053/j.jfas.2009.05.013. Epub 2009 Jul 5.
PubMed 19857819Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
PubMed 17400020Wu PT, Lee JS, Wu KC, Wu TT, Shao CJ, Liang FW, Chern TC, Su FC, Jou IM. Ultrasound-Guided Percutaneous Radiofrequency Lesioning When Treating Recalcitrant Plantar Fasciitis: Clinical Results. Ultraschall Med. 2016 Feb;37(1):56-62. doi: 10.1055/s-0034-1385466. Epub 2014 Nov 12.
PubMed 25389914Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull. 2007;81-82:183-208. doi: 10.1093/bmb/ldm005. Epub 2007 Apr 24.
PubMed 17456546Tutuncu MN, Sekizkardes M, Sahin E, Karaismailoglu B. Comparative efficacy of corticosteroid injection, extracorporeal shock wave therapy, and radiofrequency ablation for chronic plantar fasciitis: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2026 Jan 27;27(1):160. doi: 10.1186/s12891-026-09542-1.
PubMed 41593558
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Corticosteroid Injection, Extracorporeal Shock Wave Therapy, and Radiofrequency Ablation for Chronic Plantar Fasciitis: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737445
- Acronym / sponsor ID
- 27093
- Conditions
- Chronic Plantar Fasciitis
- Keywords
- extracorporeal shock wave therapy (ESWT), radiofrequency thermal lesioning (RTL), Chronic plantar fasciitis, corticosteroid injection (CSI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kars Harakani State HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 17 Dec 2024 (actual)
- 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.
Chronic plantar fasciitis is a prevalent condition causing persistent heel pain, often refractory to conservative treatments. This prospective randomized controlled trial aimed to compare the effectiveness of corticosteroid injection (CSI) , extracorporeal shock wave therapy (ESWT), and radiofrequency thermal lesioning (RTL) in the management of chronic plantar fasciitis.
Detailed description
Based on the investigators' understanding of the literature there are no randomized, controlled, prospective studies comparing the therapeutic effects of CSI, ESWT and RTL for recalcitrant plantar fasciitis. In this study, the investigators investigated and compared the outcomes of three treatment techniques in participants who had exhausted conservative treatment options over the past six months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency thermal lesioning (RTL) | Active comparator | Procedure: Radiofrequency ablation aloneRTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England). |
| Extracorporeal shock wave therapy (ESWT) | Active comparator | Other: Extracorporeal shock wave therapyPatients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA). |
| Corticosteroid Injection | Active comparator | Procedure: Cortisone InjectionAn injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Persistant heel pain for ≥ 6 months
- No response to at least 6 weeks of conservative treatment (including at least two of the following: NSAIDs, stretching exercises, ice, heel pads, physical therapy, or night splints)
- Age ≥ 18
- BMI ≤ 35
- VAS ≥ 5 following the first step in the morning or after periods of prolonged inactivity
Key exclusion criteria (17 listed)
- Previous foot or ankle surgery, major trauma
- Tumor, osteomyelitis, or complex regional pain syndrome in the affected limb
- Allergy to local anesthesia or NSAIDs
- Pregnancy or breastfeeding
- History of calcaneal fracture
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 |
|---|---|---|
| Radiofrequency ablation aloneRTL was performed as a single session using the radiofrequency ablation device (NeuroTherm JK4A; NeuroTherm Ltd, Croydon, London, England). | Procedure or surgery | Radiofrequency thermal lesioning (RTL) |
| Cortisone InjectionAn injection of 1 ml of betamethasone 40 mg/ml and 2 ml of bupivacaine 5 mg/ml was performed. | Procedure or surgery | Corticosteroid Injection |
| Extracorporeal shock wave therapyPatients underwent 3 ESWT sessions applied to the plantar heel area, once a week with the same ESWT dose (15 Hz, 2000 pulse, 4.0 bar energy density) using a BTL-5000 SWT device (BTL Industries, USA). | Other | Extracorporeal shock wave therapy (ESWT) |
Primary outcome
Visual Analog Scale (VAS) scores
Time frame: 1st month. 3rd month, 6th month
Pain score (1 to 10 points)
Foot Function Index (FFI)
Time frame: 1st month. 3rd month, 6th month,
Function score (The FFI is a self-administered index consisting of 23 items divided into 3 sub-scales.)
Roles and Maudsley Score
Time frame: 1st month. 3rd month, 6th month,
The Roles and Maudsley score is an established subjective 4-point patient assessment of pain and limitations of activity (1 = excellent result with no symptoms following treatment; 2 = significant improvement from pretreatment; 3 = patient somewhat improved; 4 = poor, symptoms identical or worse than pretreatment)
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 19 Dec 2024.
- Results publication: PubMed 32880199Erden T, Toker B, Cengiz O, Ince B, Asci S, Toprak A. Outcome of Corticosteroid Injections, Extracorporeal Shock Wave Therapy, and Radiofrequency Thermal Lesioning for Chronic Plantar Fasciitis. Foot Ankle Int. 2021 Jan;42(1):69-75. doi: 10.1177/1071100720949469. Epub 2020 Sep 3.
- Results publication: PubMed 19857819Liden B, Simmons M, Landsman AS. A retrospective analysis of 22 patients treated with percutaneous radiofrequency nerve ablation for prolonged moderate to severe heel pain associated with plantar fasciitis. J Foot Ankle Surg. 2009 Nov-Dec;48(6):642-7. doi: 10.1053/j.jfas.2009.05.013. Epub 2009 Jul 5.
- Results publication: PubMed 17400020Alshami AM, Souvlis T, Coppieters MW. A review of plantar heel pain of neural origin: differential diagnosis and management. Man Ther. 2008 May;13(2):103-11. doi: 10.1016/j.math.2007.01.014. Epub 2007 Mar 30.
- Results publication: PubMed 25389914Wu PT, Lee JS, Wu KC, Wu TT, Shao CJ, Liang FW, Chern TC, Su FC, Jou IM. Ultrasound-Guided Percutaneous Radiofrequency Lesioning When Treating Recalcitrant Plantar Fasciitis: Clinical Results. Ultraschall Med. 2016 Feb;37(1):56-62. doi: 10.1055/s-0034-1385466. Epub 2014 Nov 12.
- Results publication: PubMed 17456546Rompe JD, Furia J, Weil L, Maffulli N. Shock wave therapy for chronic plantar fasciopathy. Br Med Bull. 2007;81-82:183-208. doi: 10.1093/bmb/ldm005. Epub 2007 Apr 24.
- Derived from this study: PubMed 41593558Tutuncu MN, Sekizkardes M, Sahin E, Karaismailoglu B. Comparative efficacy of corticosteroid injection, extracorporeal shock wave therapy, and radiofrequency ablation for chronic plantar fasciitis: a prospective randomized controlled trial. BMC Musculoskelet Disord. 2026 Jan 27;27(1):160. doi: 10.1186/s12891-026-09542-1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation alone, Cortisone Injection and Extracorporeal shock wave therapy in people with Chronic Plantar Fasciitis, run by Kars Harakani State Hospital at 1 site in Turkey (Türkiye).
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 6 inclusion and 17 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 19 Dec 2024. 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 Turkey (Türkiye). 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. 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?
Visual Analog Scale (VAS) scores (time frame: 1st month. 3rd month, 6th month). The study lists 3 primary outcomes in all. 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 NCT06737445, which also lists 6 linked publications.
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 19 Dec 2024.