Heel SpurNCT06240507
Posterior Tibial Nerve PRF vs Intralesional RFT for Painful Calcaneal Spur and Plantar Fasciitis
A study testing ultrasound-guided posterior tibial nerve pulsed radiofrequency and fluoroscopy-guided intralesional radiofrequency thermocoagulation in people with Heel Spur and Plantar Fascitis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) and fluoroscopy (FL)-guided intralesional radiofrequency thermocoagulation (RFT) for the treatment of painful calcaneal spur and plantar fasciitis refractory to conservative treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heel Spur, Plantar Fascitis
- What is being tested?
- ultrasound-guided posterior tibial nerve pulsed radiofrequency and fluoroscopy-guided intralesional radiofrequency thermocoagulation
- Type of treatment
- 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
- 2 Jan 2023to 1 Sep 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Heel pain for at least 6 months consistent with clinical examination and imaging methods
- Numeric rating scale (NRS) in the first few steps in the morning ≥ 6
- Plantar fascia thicker than 4 mm as measured by ultrasonography
- Demonstration of calcaneal spur by X-ray
- Non-response to at least two of the indicated conservative treatments (rest, stretching exercises, oral anti-inflammatory drugs, silicone heel cup, local steroid injection, extracorporeal shock wave therapy (ESWT))
Who cannot join
- Achilles tendinopathy or calcaneal fracture
- Inflammatory or degenerative arthritis
- Spondyloarthropathies
- Tarsal tunnel syndrome (confirmed by electromyography if clinically suspected)
- Previous surgery on the plantar fascia or heel
- Diabetes mellitus, peripheral neuropathies, peripheral ischemic disease
- History of malignancy, pregnancy
- Anticoagulant-anticoaggregant drug use or coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Ultrasound-guided Posterior Tibial Nerve Pulsed Radiofrequency and Fluoroscopy-guided Intralesional Radiofrequency Thermocoagulation in the Treatment of Painful Calcaneal Spur and Plantar Fasciitis
This study aims to compare the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) and fluoroscopy (FL)-guided intralesional radiofrequency thermocoagulation (RFT) for the treatment of painful calcaneal spur and plantar fasciitis refractory to conservative treatments. For this evaluation, a numerical rating (NRS) and the American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scores will be used before and after both interventions.
Read the detailed description
Painful calcaneal spurs (PCS) and plantar fasciitis (PF) are common foot conditions affecting approximately 10-15% of the population. These conditions can cause severe heel pain and disability, affecting the patients' quality of life and productivity.
Treatment of these conditions is complex and sometimes resistant to conventional therapies, such as rest, ice, stretching, orthotics, and anti-inflammatory drugs. Some studies have shown that conservative treatments can improve PCS and PF symptoms within 12 months. However, if conservative treatments fail, interventional procedures such as corticosteroid injections, radiofrequency ablation, or surgery may be used on the PCS and surrounding nerves.
PRF and RFT are two modalities of thermal ablation that can be used to treat chronic pain conditions. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation, and can promote thinning of hard tissues, such as calcaneal spurs and plantar fascia. The PTN is a branch of the sciatic nerve that provides sensory and motor innervation to the heel and sole of the foot, where calcaneal spurs and PF occur. The advantage of the PTN over its smaller branches is that it can be visualized and targeted using US. FL can visualize PCS.
US-guided PTN PRF and FL-guided intralesional RFT for pain management in PCS and PF have been used in a limited number of studies; however, no studies have compared their efficacy and adverse event rates.
The primary aim of this study was to compare the efficacy of these two treatment modalities. The secondary aim was to determine the incidence of adverse events associated with US-guided PTN PRF and FL-guided intralesional TRF treatment. A total of at least 46 patients, 23 patients in each group, will be enrolled for comparison. NRS, and AOFAS scores before, 1 month, and 3 months after treatment will be compared both within and between groups.
- Conditions
- Heel Spur, Plantar Fascitis
- Being tested
- ultrasound-guided posterior tibial nerve pulsed radiofrequency, fluoroscopy-guided intralesional radiofrequency thermocoagulation
- Keywords
- Pulsed Radiofrequency Treatment, Ultrasonography, Fluoroscopy, Tibial Nerve
- Medical subject headings
- Heel Spur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided posterior tibial nerve pulsed radiofrequencyProcedure or surgery
The posterior tibial nerve (PTN) was identified with a 5-12 MHz linear ultrasonography (US) probe at the level of the medial malleolus, where it runs posterior to the posterior tibial artery. Using the in-plane technique, a 22-gauge, 10-cm radiofrequency cannula was inserted under US guidance and advanced until the tip was adjacent to the nerve. Pulse radiofrequency was applied at 42°C for 240 s with a pulse width of 20 ms
fluoroscopy-guided intralesional radiofrequency thermocoagulationProcedure or surgery
The painful heel and calcaneal spur were visualized under lateral fluoroscopy. A 22-gauge, 10-cm radiofrequency cannula was inserted and advanced until the needle tip reached the calcaneal spur tip. When the needle tip contacted the spur, local anesthetic was administered through the cannula and radiofrequency ablation was performed at 80°C for 90 s.
| Study group | Role | What they receive |
|---|---|---|
| pulsed radiofrequency group | Active comparator | posterior tibial nerve pulsed radiofrequency for painful calcaneal spur and plantar fasciitis Receives: Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequency |
| radiofrequency thermocoagulation group | Active comparator | intralesional radiofrequency thermocoagulation for painful calcaneal spur and plantar fasciitis Receives: Procedure: fluoroscopy-guided intralesional radiofrequency thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale (NRS)
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
Measured: Change from baseline to 1st and 3rd month after treatment
Secondary outcomes (1)
The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score
The AOFAS ankle-hindfoot score is used to measure the treatment outcome for ankle and hindfoot problems. It consists of three parts: pain, function, and alignment. Pain is worth 40 points, function is worth 50 points, and alignment is worth 10 points. The total score ranges from 0 to 100, with higher scores indicating better outcomes.
Measured: Change from baseline to 3rd month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Jan 2023
- Primary completion5 Aug 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heel SpurStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- Gevher Rabia Genc Perdecioğlu, Study chair, Diskapi TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240507
- Sponsor's protocol ID
- PTN PRF vs intralesional RFT
- Status last verified
- Jan 2024
- First submitted
- 26 Jan 2024
- Last updated
- 5 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yildiz G, Perdecioglu GRG, Yuruk D, Can E, Akkaya OT. Comparison of tibial nerve pulsed radiofrequency and intralesional radiofrequency thermocoagulation in the treatment of painful calcaneal spur and plantar fasciitis: a randomized clinical trial. Pain Med. 2024 Aug 1;25(8):493-499. doi: 10.1093/pm/pnae029.
PubMed 38652568
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-guided Posterior Tibial Nerve Pulsed Radiofrequency and Fluoroscopy-guided Intralesional Radiofrequency Thermocoagulation in the Treatment of Painful Calcaneal Spur and Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT06240507
- Acronym / sponsor ID
- PTN PRF vs intralesional RFT
- Conditions
- Heel Spur, Plantar Fascitis
- Keywords
- Pulsed Radiofrequency Treatment, Ultrasonography, Fluoroscopy, Tibial Nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 5 Feb 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.
This study aims to compare the efficacy of ultrasound (US)-guided posterior tibial nerve pulsed radiofrequency (PTN PRF) and fluoroscopy (FL)-guided intralesional radiofrequency thermocoagulation (RFT) for the treatment of painful calcaneal spur and plantar fasciitis refractory to conservative treatments. For this evaluation, a numerical rating (NRS) and the American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot scores will be used before and after both interventions.
Detailed description
Painful calcaneal spurs (PCS) and plantar fasciitis (PF) are common foot conditions affecting approximately 10-15% of the population. These conditions can cause severe heel pain and disability, affecting the patients' quality of life and productivity.
Treatment of these conditions is complex and sometimes resistant to conventional therapies, such as rest, ice, stretching, orthotics, and anti-inflammatory drugs. Some studies have shown that conservative treatments can improve PCS and PF symptoms within 12 months. However, if conservative treatments fail, interventional procedures such as corticosteroid injections, radiofrequency ablation, or surgery may be used on the PCS and surrounding nerves.
PRF and RFT are two modalities of thermal ablation that can be used to treat chronic pain conditions. PRF delivers short bursts of high-voltage electrical current to the target nerve, creating a non-thermal effect that modulates the transmission of pain signals. RFT delivers a continuous current that heats the target tissue, causing coagulation, and can promote thinning of hard tissues, such as calcaneal spurs and plantar fascia. The PTN is a branch of the sciatic nerve that provides sensory and motor innervation to the heel and sole of the foot, where calcaneal spurs and PF occur. The advantage of the PTN over its smaller branches is that it can be visualized and targeted using US. FL can visualize PCS.
US-guided PTN PRF and FL-guided intralesional RFT for pain management in PCS and PF have been used in a limited number of studies; however, no studies have compared their efficacy and adverse event rates.
The primary aim of this study was to compare the efficacy of these two treatment modalities. The secondary aim was to determine the incidence of adverse events associated with US-guided PTN PRF and FL-guided intralesional TRF treatment. A total of at least 46 patients, 23 patients in each group, will be enrolled for comparison. NRS, and AOFAS scores before, 1 month, and 3 months after treatment will be compared both within and between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pulsed radiofrequency group | Active comparator | Procedure: ultrasound-guided posterior tibial nerve pulsed radiofrequencyposterior tibial nerve pulsed radiofrequency for painful calcaneal spur and plantar fasciitis |
| radiofrequency thermocoagulation group | Active comparator | Procedure: fluoroscopy-guided intralesional radiofrequency thermocoagulationintralesional radiofrequency thermocoagulation for painful calcaneal spur and plantar fasciitis |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Heel pain for at least 6 months consistent with clinical examination and imaging methods
- Numeric rating scale (NRS) in the first few steps in the morning ≥ 6
- Plantar fascia thicker than 4 mm as measured by ultrasonography
- Demonstration of calcaneal spur by X-ray
- Non-response to at least two of the indicated conservative treatments (rest, stretching exercises, oral anti-inflammatory drugs, silicone heel cup, local steroid injection, extracorporeal shock wave therapy (ESWT))
Key exclusion criteria (8 listed)
- Achilles tendinopathy or calcaneal fracture
- Inflammatory or degenerative arthritis
- Spondyloarthropathies
- Tarsal tunnel syndrome (confirmed by electromyography if clinically suspected)
- Previous surgery on the plantar fascia or heel
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 |
|---|---|---|
| ultrasound-guided posterior tibial nerve pulsed radiofrequencyThe posterior tibial nerve (PTN) was identified with a 5-12 MHz linear ultrasonography (US) probe at the level of the medial malleolus, where it runs posterior to the posterior tibial artery. Using the in-plane technique, a 22-gauge, 10-cm radiofrequency cannula was inserted under US guidance and advanced until the tip was adjacent to the nerve. Pulse radiofrequency was applied at 42°C for 240 s with a pulse width of 20 ms | Procedure or surgery | pulsed radiofrequency group |
| fluoroscopy-guided intralesional radiofrequency thermocoagulationThe painful heel and calcaneal spur were visualized under lateral fluoroscopy. A 22-gauge, 10-cm radiofrequency cannula was inserted and advanced until the needle tip reached the calcaneal spur tip. When the needle tip contacted the spur, local anesthetic was administered through the cannula and radiofrequency ablation was performed at 80°C for 90 s. | Procedure or surgery | radiofrequency thermocoagulation group |
Primary outcome
Numerical rating scale (NRS)
Time frame: Change from baseline to 1st and 3rd month after treatment
NRS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)
1 secondary outcome
The American Orthopedic Foot and Ankle Society (AOFAS) ankle hindfoot score
Time frame: Change from baseline to 3rd month after treatment
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 5 Feb 2024.
- Derived from this study: PubMed 38652568Yildiz G, Perdecioglu GRG, Yuruk D, Can E, Akkaya OT. Comparison of tibial nerve pulsed radiofrequency and intralesional radiofrequency thermocoagulation in the treatment of painful calcaneal spur and plantar fasciitis: a randomized clinical trial. Pain Med. 2024 Aug 1;25(8):493-499. doi: 10.1093/pm/pnae029.
Related trials for Heel Spur
Recruiting
Effectiveness of Pulsed Electromagnetic Field Therapy in Patients With Symptomatic Plantar Calcaneal Spurs
Calcaneal Spur
RecruitingObservational study
Effect of Additional Sural Nerve PRF in Chronic Heel Pain
Chronic Plantar Heel Pain, Plantar Fasciitis
RecruitingObservational study
Establishment and Evaluation of Standardized Clinical, Biological and Imaging Parameters to Assess the Response of LDRT in Heel Spur With Plantar Fasciitis
Calcaneal Spur
Recruiting
Optimal Radiotherapy - Heel Spur Syndrome - Randomized Clinical Trial
Heel Spur Syndrome
Not yet recruiting
Calcaneal Osteotomy for Recalcitrant Planter Fasciosis
Plantar Fascitis
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.
Gevher Rabia Genc Perdecioğlu study chair
Diskapi TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound-guided posterior tibial nerve pulsed radiofrequency and fluoroscopy-guided intralesional radiofrequency thermocoagulation in people with Heel Spur and Plantar Fascitis, run by Diskapi Teaching and Research 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 5 inclusion and 8 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 5 Feb 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?
Numerical rating scale (NRS) (time frame: Change from baseline to 1st and 3rd month after treatment). 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 NCT06240507, which also lists 1 linked publication.
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 5 Feb 2024; AzTrials last refreshed its copy on 8 Nov 2026.