Fasciitis, PlantarNCT06426667
Effect of Radiofrequency Treatment in Plantar Fasciitis Patients
An observational study of Fasciitis, Plantar, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fasciitis, Plantar
- What is being tested?
- posterior tibial nerve radiofrequency and plantar fasciitis radiofrequency
- Type of treatment
- Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2024to 30 Nov 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients between the ages of 18 and 65 who are scheduled to receive radiofrequency tretament due to plantar fasciitis will be included in the study.
Who may be able to join
- 18-65 years old,
- Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination,
- Visual analog scale is 4 or more
- No response to conservative treatment (medical and physical medicine modalities)
Who cannot join
- History of trauma or calcaneus fracture,
- Osteoarthritis, Diabetes mellitus, chronic heart disease
- Presence of pregnancy,
- Pain due to peripheral neuropathy or ischemia
- Inability to tolerate injections in the heel area,
- Allergy to local anesthetics or steroids,
Show all 14Show fewer
- Presence of an open wound on the side of the foot that the injection will be performed
- Local or systemic infection at the time of the procedure
- Previous steroid injection, radiofrequency application or ESWT (electroshock wave) treatment into the heel
- History of surgical intervention to the heel
- Presence of any functional limitation in the affected foot
- Presence of neurological, hepatic and/or metabolic diseases; dermatological infections, seronegative spondyloarthropathy, bleeding diathesis
- Failure to discontinue anticoagulant or antiaggregant within the specified periods
- Absence of follow-up throughout the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Radiofrequency Treatments on Foot Functionality Index, Patient Satisfaction and Pain Scores in Plantar Fasciitis Patients
In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis
Read the detailed description
Chronic plantar fasciitis is the most common cause of chronic heel pain in adults. Typically, patients describe a throbbing pain localized around the origin of the plantar fascia on the calcaneus. This pain is often most severe when taking the first steps in the morning or rising after sitting. It typically improves with activity but worsens with prolonged activity. The primary aim of heel spur treatment is to alleviate pain and restore function. Surgical interventions are recommended for chronic plantar heel pain resistant to conservative options. However, surgery may be associated with prolonged recovery, and in one study, superiority over conservative treatment was not demonstrated. Radiofrequency has been shown to be an effective treatment method for chronic plantar heel pain in many randomized and non-randomized studies. In many studies, most of these procedures are applied blindly based on anatomical landmarks, with attention drawn in many studies to applications targeting the terminal branches of the posterior tibial nerve or the spur region. Only a few studies have been performed using fluoroscopy and ultrasound guidance. Ultrasound guidance offers several advantages over fluoroscopy and blind landmark techniques, especially in interventional procedures targeting neural and soft tissues. These advantages include the ability to visualize vascular and neural structures, very low risk of vascular-neural injury, absence of radiation exposure, and superiority in cases of anatomical variation. However, a common point in many studies related to plantar fasciitis is that applications are either directed to the spur area or to neural structures leading to the heel region. In this study, we aim to compare the effects of radiofrequency modalities applied to the posterior tibial nerve and/or calcaneal spur area under ultrasound guidance on patient satisfaction, pain scores, and patient functionality in cases of chronic plantar fasciitis (heel spur).
- Conditions
- Fasciitis, Plantar
- Being tested
- posterior tibial nerve radiofrequency, plantar fasciitis radiofrequency
- Keywords
- Fasciitis, Plantar, Radiofrequency 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.
posterior tibial nerve radiofrequencyProcedure or surgery
pulse radiofrequency at 45 V for 300 seconds at 42 degrees Celsius is applied to the posterior tibial nerve area. During the procedure, the temperature at the electrode tip is kept below 42°C. Following negative aspiration (in the absence of blood), 2 cc of 1% lidocaine + 4 mg dexamethasone is applied to the same area.
plantar fasciitis radiofrequencyProcedure or surgery
the spur area on the calcaneal bone is identified, and sensory and motor stimulations are applied using the RF cannula. If no sensory or motor response is elicited in the area, conventional radiofrequency at 45 V for 60 seconds at 80 degrees Celsius is applied to the spur area after confirming the placement of the RF cannula.
| Study group | Role | What they receive |
|---|---|---|
| posterior tibial nerve radiofrequency | posterior tibial nerve pulsed radiofrequency treatment Receives: Procedure: posterior tibial nerve radiofrequency | |
| plantar fasciitis radiofrequency | calcaneal spur thermocoagulation radiofrequency treatment Receives: Procedure: plantar fasciitis radiofrequency | |
| posterior tibial nerve and plantar fasciitis radiofrequency | posterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment Receives: Procedure: posterior tibial nerve radiofrequency; Procedure: plantar fasciitis radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
pain severity change by using Numeric Rating Scala will be observed before and at 1 week, 1, 3 months after the procedure.
pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 1 and 3 months
Patient satisfaction after the procedure
Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied".
Measured: 1 and 3 months
functionallity
Functionality of foot will be observed at before the procedure and 1 week, 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases.
Measured: 1 and 3 months
medication use
number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated
Measured: 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start15 Apr 2024
- Primary completion30 Jul 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fasciitis, PlantarStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanzade Aybuke Unal, Ankara University
- Investigators
- Hanzade A Unal, MD, Study director, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426667
- Sponsor's protocol ID
- 2024/202
- Status last verified
- May 2024
- First submitted
- 18 May 2024
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.
PubMed 35097359Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819.
PubMed 30412072Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14.
PubMed 28209507Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5.
PubMed 30661127
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radiofrequency Treatments on Foot Functionality Index, Patient Satisfaction and Pain Scores in Plantar Fasciitis Patients
- ClinicalTrials.gov ID
- NCT06426667
- Acronym / sponsor ID
- 2024/202
- Conditions
- Fasciitis, Plantar
- Keywords
- Fasciitis, Plantar, Radiofrequency Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 23 May 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.
In adults, chronic plantar fasciitis stands as the predominant cause of persistent heel discomfort.Usually, individuals depict a pulsating pain concentrated around the point of origin of the plantar fascia on the calcaneus. Numerous randomized and non-randomized studies have demonstrated the effectiveness of radiofrequency as a treatment modality for chronic plantar heel pain.In this study, our objective is to assess the impact of radiofrequency modalities applied to the posterior tibial nerve and/or the calcaneal spur area, guided by ultrasound, on patient satisfaction, pain scores, and functional improvement in individuals with chronic plantar fasciitis
Detailed description
Chronic plantar fasciitis is the most common cause of chronic heel pain in adults. Typically, patients describe a throbbing pain localized around the origin of the plantar fascia on the calcaneus. This pain is often most severe when taking the first steps in the morning or rising after sitting. It typically improves with activity but worsens with prolonged activity. The primary aim of heel spur treatment is to alleviate pain and restore function. Surgical interventions are recommended for chronic plantar heel pain resistant to conservative options. However, surgery may be associated with prolonged recovery, and in one study, superiority over conservative treatment was not demonstrated. Radiofrequency has been shown to be an effective treatment method for chronic plantar heel pain in many randomized and non-randomized studies. In many studies, most of these procedures are applied blindly based on anatomical landmarks, with attention drawn in many studies to applications targeting the terminal branches of the posterior tibial nerve or the spur region. Only a few studies have been performed using fluoroscopy and ultrasound guidance. Ultrasound guidance offers several advantages over fluoroscopy and blind landmark techniques, especially in interventional procedures targeting neural and soft tissues. These advantages include the ability to visualize vascular and neural structures, very low risk of vascular-neural injury, absence of radiation exposure, and superiority in cases of anatomical variation. However, a common point in many studies related to plantar fasciitis is that applications are either directed to the spur area or to neural structures leading to the heel region. In this study, we aim to compare the effects of radiofrequency modalities applied to the posterior tibial nerve and/or calcaneal spur area under ultrasound guidance on patient satisfaction, pain scores, and patient functionality in cases of chronic plantar fasciitis (heel spur).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| posterior tibial nerve radiofrequency | – | Procedure: posterior tibial nerve radiofrequencyposterior tibial nerve pulsed radiofrequency treatment |
| plantar fasciitis radiofrequency | – | Procedure: plantar fasciitis radiofrequencycalcaneal spur thermocoagulation radiofrequency treatment |
| posterior tibial nerve and plantar fasciitis radiofrequency | – | Procedure: posterior tibial nerve radiofrequency, Procedure: plantar fasciitis radiofrequencyposterior tibial nerve pulsed radiofrequency and calcaneal spur thermocoagulation radiofrequency treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients between the ages of 18 and 65 who are scheduled to receive radiofrequency tretament due to plantar fasciitis will be included in the study.
Key inclusion criteria (4 listed)
- 18-65 years old,
- Heel pain for at least 6 months and a diagnosis of plantar fasciitis confirmed by direct radiography and physical examination,
- Visual analog scale is 4 or more
- No response to conservative treatment (medical and physical medicine modalities)
Key exclusion criteria (14 listed)
- History of trauma or calcaneus fracture,
- Osteoarthritis, Diabetes mellitus, chronic heart disease
- Presence of pregnancy,
- Pain due to peripheral neuropathy or ischemia
- Inability to tolerate injections in the heel area,
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 |
|---|---|---|
| posterior tibial nerve radiofrequencypulse radiofrequency at 45 V for 300 seconds at 42 degrees Celsius is applied to the posterior tibial nerve area. During the procedure, the temperature at the electrode tip is kept below 42°C. Following negative aspiration (in the absence of blood), 2 cc of 1% lidocaine + 4 mg dexamethasone is applied to the same area. | Procedure or surgery | posterior tibial nerve and plantar fasciitis radiofrequency, posterior tibial nerve radiofrequency |
| plantar fasciitis radiofrequencythe spur area on the calcaneal bone is identified, and sensory and motor stimulations are applied using the RF cannula. If no sensory or motor response is elicited in the area, conventional radiofrequency at 45 V for 60 seconds at 80 degrees Celsius is applied to the spur area after confirming the placement of the RF cannula. | Procedure or surgery | plantar fasciitis radiofrequency, posterior tibial nerve and plantar fasciitis radiofrequency |
Primary outcome
pain severity
Time frame: 1 and 3 months
pain severity change by using Numeric Rating Scala will be observed before and at 1 week, 1, 3 months after the procedure. pain severity change by using Numeric Ratin Scala was observed 3 months after the procedure.The 11-point numerical scale ranges from '0', representing "no pain", to '10', representing extreme pain (e.g., "pain as bad as you can imagine" or "worst pain imaginable").
Patient satisfaction after the procedure
Time frame: 1 and 3 months
Patients will evaluate their satisfaction after the procedure as "satisfied", "uncertain" or "not satisfied".
functionallity
Time frame: 1 and 3 months
Functionality of foot will be observed at before the procedure and 1 week, 1, 3 months after the procedure. Foot functionalliy index will be used. Foot function index consists of 23 items with 3 subgroups: pain, disability and activity limitation. To calculate the subscales and total score, the scores of each item are summed, divided by the sum of the maximum scores of the items and multiplied by 100. Higher scores indicate more pain, disability, and activity limitation. The survey score varies between 0-100, and as the score increases, the disability increases.
medication use
Time frame: 1 and 3 months
number of medication use (nonsteroidal anttinflamatort drugs, opioids, muscle relaxants) wiil be evaluated
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 13 Jun 2025.
- Background: PubMed 35097359Latt LD, Jaffe DE, Tang Y, Taljanovic MS. Evaluation and Treatment of Chronic Plantar Fasciitis. Foot Ankle Orthop. 2020 Feb 13;5(1):2473011419896763. doi: 10.1177/2473011419896763. eCollection 2020 Jan.
- Background: PubMed 30412072Li X, Zhang L, Gu S, Sun J, Qin Z, Yue J, Zhong Y, Ding N, Gao R. Comparative effectiveness of extracorporeal shock wave, ultrasound, low-level laser therapy, noninvasive interactive neurostimulation, and pulsed radiofrequency treatment for treating plantar fasciitis: A systematic review and network meta-analysis. Medicine (Baltimore). 2018 Oct;97(43):e12819. doi: 10.1097/MD.0000000000012819.
- Background: PubMed 28209507Wu YT, Chang CY, Chou YC, Yeh CC, Li TY, Chu HY, Chen LC. Ultrasound-Guided Pulsed Radiofrequency Stimulation of Posterior Tibial Nerve: A Potential Novel Intervention for Recalcitrant Plantar Fasciitis. Arch Phys Med Rehabil. 2017 May;98(5):964-970. doi: 10.1016/j.apmr.2017.01.016. Epub 2017 Feb 14.
- Background: PubMed 30661127Orhurhu V, Urits I, Orman S, Viswanath O, Abd-Elsayed A. A Systematic Review of Radiofrequency Treatment of the Ankle for the Management of Chronic Foot and Ankle Pain. Curr Pain Headache Rep. 2019 Jan 19;23(1):4. doi: 10.1007/s11916-019-0745-5.
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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.
Hanzade A Unal, MD study director
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fasciitis, Plantar, run by Ankara University 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 4 inclusion and 14 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 13 Jun 2025. 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?
pain severity (time frame: 1 and 3 months). The study lists 4 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 NCT06426667, which also lists 4 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 13 Jun 2025.