Chronic Plantar FasciitisNCT07688876
Pulsed Radiofrequency Versus 5% Dextrose Injection in Chronic Plantar Fasciitis
A study testing Ultrasound-Guided Pulsed Radiofrequency Treatment and Ultrasound-Guided 5% Dextrose Injection in people with Chronic Plantar Fasciitis and Chronic Heel Pain, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This prospective, two-center, randomized controlled clinical trial aims to compare the effectiveness of ultrasound-guided pulsed radiofrequency and 5% dextrose injection in patients with chronic plantar fasciitis. Eligible participants will be randomized into two parallel groups. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Plantar Fasciitis, Chronic Heel Pain, Foot Pain
- What is being tested?
- Ultrasound-Guided Pulsed Radiofrequency Treatment and Ultrasound-Guided 5% Dextrose Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic plantar fasciitis based on medical history and physical examination
- Heel pain resistant to conservative treatment for at least 12 weeks
- Age between 18 and 70 years
- Willingness to participate in the study and provide written informed consent
Who cannot join
- Congenital or acquired disease that may impair or prevent foot function, such as rheumatoid arthritis, hemiplegia, congenital foot deformity, traumatic foot or leg amputation, or fracture sequelae
- Local infection or skin disease at the treatment site
- Bleeding disorder or use of anticoagulant medication within the last week
- Disease causing mental dysfunction, such as uncontrolled Parkinson disease or Alzheimer disease
- Previous surgery for plantar fasciitis
- Refusal to participate in the study or inability to provide informed consent
Show all 13Show fewer
- Failure to attend follow-up visits after treatment
- Request to withdraw from the study
- Pregnancy or suspected pregnancy
- Presence of a cardiac pacemaker
- History of epilepsy
- Active or previous malignancy
- Rheumatologic disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
Ankara
Esra Ülgen Kıratlıoğlu, +905079614194, esraulgen@gmail.com
About this study
Official title: Comparison of Ultrasound-Guided Pulsed Radiofrequency and 5% Dextrose Injection in Patients With Chronic Plantar Fasciitis: A Randomized Controlled Trial
This prospective, two-center, randomized controlled clinical trial aims to compare the effectiveness of ultrasound-guided pulsed radiofrequency and 5% dextrose injection in patients with chronic plantar fasciitis. Eligible participants will be randomized into two parallel groups. One group will receive ultrasound-guided pulsed radiofrequency treatment, and the other group will receive ultrasound-guided 5% dextrose injection using the peppering technique. All participants will receive a home-based plantar fascia stretching exercise program. Outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Numeric Rating Scale. Secondary outcomes will include foot function, activity-related pain, ankle-hindfoot function, and health-related quality of life.
Read the detailed description
Plantar fasciitis is one of the most common causes of chronic heel pain in adults. It may impair walking pattern, daily activities, social life, and work-related functioning. Although conservative treatments are commonly used as first-line therapy, symptoms may become chronic in a considerable proportion of patients.
Dextrose injection is a regenerative injection treatment used in chronic musculoskeletal pain conditions. It is thought to stimulate local tissue healing responses through controlled inflammatory and proliferative mechanisms. Pulsed radiofrequency is a minimally invasive, non-neurodestructive radiofrequency technique used for pain control. Both pulsed radiofrequency and dextrose injection are used in clinical practice for resistant chronic plantar fasciitis; however, comparative data between these two approaches are limited.
This study will be conducted as a prospective, two-center, two-arm, parallel-group randomized controlled trial in the Physical Medicine and Rehabilitation clinics of Ankara Bilkent City Hospital and Adana City Hospital. Participants with chronic plantar fasciitis will be randomized in a 1:1 ratio using the sealed-envelope method. The investigator responsible for randomization will know the allocation, while the outcomes assessor will be blinded to treatment allocation. Blinding of the interventionists will not be possible due to the nature of the procedures.
Participants in the pulsed radiofrequency group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Participants in the 5% dextrose group will receive ultrasound-guided 5% dextrose injection around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. Dextrose injections will be performed in three sessions at 3-week intervals.
All participants will receive a home-based plantar fascia stretching exercise program. Exercises will be demonstrated by a physiotherapist, and participants will be instructed to perform the exercises twice daily for 12 weeks. Participants will be monitored for possible adverse events or complications for at least 30 minutes after the procedure. Clinical outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks.
- Conditions
- Chronic Plantar Fasciitis, Chronic Heel Pain, Foot Pain
- Being tested
- Ultrasound-Guided Pulsed Radiofrequency Treatment, Ultrasound-Guided 5% Dextrose Injection
- Keywords
- Pulsed radiofrequency, Radiofrequency treatment, Dextrose injection, Prolotherapy, Ultrasound-guided injection, Plantar fascia, Chronic heel pain, Numeric Rating Scale, Foot Function Index, AOFAS score, Nottingham Health Profile
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-Guided Pulsed Radiofrequency TreatmentProcedure or surgery
Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications.
Ultrasound-Guided 5% Dextrose InjectionProcedure or surgery
Ultrasound-guided 5% dextrose injection will be applied around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. The treatment will consist of three sessions performed at 3-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Pulsed Radiofrequency Treatment | Experimental | Participants in this group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Clinical follow-up assessments will be performed at 3 weeks, 6 weeks, and 12 weeks. All participants will also receive a home-based plantar fascia stretching exercise program. Receives: Procedure: Ultrasound-Guided Pulsed Radiofrequency Treatment |
| Ultrasound-Guided 5% Dextrose Injection | Active comparator | Ultrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications. Receives: Procedure: Ultrasound-Guided 5% Dextrose Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heel Pain Intensity Assessed by Numeric Rating Scale
Heel pain intensity will be assessed using the Numeric Rating Scale. Resting pain, pain during plantar fascia stretching, and pain with pressure will be evaluated on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Secondary outcomes (4)
Change in Activity-Related Pain Assessed by the Roles and Maudsley Score
Activity-related heel pain and functional status will be assessed using the Roles and Maudsley Score. The score ranges from 1 to 4, with lower scores indicating better clinical status and higher scores indicating worse pain and functional limitation.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Foot Function Assessed by the Foot Function Index
Foot-related pain, disability, and activity limitation will be assessed using the Foot Function Index. The scale includes pain, disability, and activity limitation subscales. Scores are converted to a 0-100 scale, with higher scores indicating greater pain, disability, and activity limitation.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Ankle-Hindfoot Function Assessed by the American Orthopaedic Foot and Ankle Society Score
Ankle-hindfoot function will be assessed using the American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score. The score evaluates pain, function, and alignment. The total score ranges from 0 to 100, with higher scores indicating better ankle-hindfoot function.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile
Health-related quality of life will be assessed using the Nottingham Health Profile. The questionnaire includes six domains: energy level, pain, emotional reactions, sleep, social isolation, and physical activity. The total score ranges from 0 to 600, with higher scores indicating worse perceived health status.
Measured: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plantar FasciitisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized into two parallel groups: ultrasound-guided pulsed radiofrequency treatment and ultrasound-guided 5% dextrose injection.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688876
- Sponsor's protocol ID
- E2-26-14591
- Status last verified
- Jun 2026
- First submitted
- 30 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound-Guided Pulsed Radiofrequency and 5% Dextrose Injection in Patients With Chronic Plantar Fasciitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07688876
- Acronym / sponsor ID
- E2-26-14591
- Conditions
- Chronic Plantar Fasciitis, Chronic Heel Pain, Foot Pain
- Keywords
- Pulsed radiofrequency, Radiofrequency treatment, Dextrose injection, Prolotherapy, Ultrasound-guided injection, Plantar fascia, Chronic heel pain, Numeric Rating Scale
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Jul 2026 (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 prospective, two-center, randomized controlled clinical trial aims to compare the effectiveness of ultrasound-guided pulsed radiofrequency and 5% dextrose injection in patients with chronic plantar fasciitis. Eligible participants will be randomized into two parallel groups. One group will receive ultrasound-guided pulsed radiofrequency treatment, and the other group will receive ultrasound-guided 5% dextrose injection using the peppering technique. All participants will receive a home-based plantar fascia stretching exercise program. Outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks after treatment. The primary outcome will be pain intensity measured by the Numeric Rating Scale. Secondary outcomes will include foot function, activity-related pain, ankle-hindfoot function, and health-related quality of life.
Detailed description
Plantar fasciitis is one of the most common causes of chronic heel pain in adults. It may impair walking pattern, daily activities, social life, and work-related functioning. Although conservative treatments are commonly used as first-line therapy, symptoms may become chronic in a considerable proportion of patients.
Dextrose injection is a regenerative injection treatment used in chronic musculoskeletal pain conditions. It is thought to stimulate local tissue healing responses through controlled inflammatory and proliferative mechanisms. Pulsed radiofrequency is a minimally invasive, non-neurodestructive radiofrequency technique used for pain control. Both pulsed radiofrequency and dextrose injection are used in clinical practice for resistant chronic plantar fasciitis; however, comparative data between these two approaches are limited.
This study will be conducted as a prospective, two-center, two-arm, parallel-group randomized controlled trial in the Physical Medicine and Rehabilitation clinics of Ankara Bilkent City Hospital and Adana City Hospital. Participants with chronic plantar fasciitis will be randomized in a 1:1 ratio using the sealed-envelope method. The investigator responsible for randomization will know the allocation, while the outcomes assessor will be blinded to treatment allocation. Blinding of the interventionists will not be possible due to the nature of the procedures.
Participants in the pulsed radiofrequency group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Participants in the 5% dextrose group will receive ultrasound-guided 5% dextrose injection around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. Dextrose injections will be performed in three sessions at 3-week intervals.
All participants will receive a home-based plantar fascia stretching exercise program. Exercises will be demonstrated by a physiotherapist, and participants will be instructed to perform the exercises twice daily for 12 weeks. Participants will be monitored for possible adverse events or complications for at least 30 minutes after the procedure. Clinical outcomes will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized into two parallel groups: ultrasound-guided pulsed radiofrequency treatment and ultrasound-guided 5% dextrose injection.
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Pulsed Radiofrequency Treatment | Experimental | Procedure: Ultrasound-Guided Pulsed Radiofrequency TreatmentParticipants in this group will receive ultrasound-guided pulsed radiofrequency treatment at baseline. Clinical follow-up assessments will be performed at 3 weeks, 6 weeks, and 12 weeks. All participants will also receive a home-based plantar fascia stretching exercise program. |
| Ultrasound-Guided 5% Dextrose Injection | Active comparator | Procedure: Ultrasound-Guided 5% Dextrose InjectionUltrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of chronic plantar fasciitis based on medical history and physical examination
- Heel pain resistant to conservative treatment for at least 12 weeks
- Age between 18 and 70 years
- Willingness to participate in the study and provide written informed consent
Key exclusion criteria (13 listed)
- Congenital or acquired disease that may impair or prevent foot function, such as rheumatoid arthritis, hemiplegia, congenital foot deformity, traumatic foot or leg amputation, or fracture sequelae
- Local infection or skin disease at the treatment site
- Bleeding disorder or use of anticoagulant medication within the last week
- Disease causing mental dysfunction, such as uncontrolled Parkinson disease or Alzheimer disease
- Previous surgery for plantar fasciitis
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 Pulsed Radiofrequency TreatmentUltrasound-guided pulsed radiofrequency treatment will be applied for chronic plantar fasciitis. Participants will be monitored for at least 30 minutes after the procedure for possible adverse events or complications. | Procedure or surgery | Ultrasound-Guided Pulsed Radiofrequency Treatment |
| Ultrasound-Guided 5% Dextrose InjectionUltrasound-guided 5% dextrose injection will be applied around the medial calcaneal insertion of the plantar fascia using the peppering technique, with 0.1-0.2 mL administered at each entry point. The treatment will consist of three sessions performed at 3-week intervals. | Procedure or surgery | Ultrasound-Guided 5% Dextrose Injection |
Primary outcome
Change in Heel Pain Intensity Assessed by Numeric Rating Scale
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Heel pain intensity will be assessed using the Numeric Rating Scale. Resting pain, pain during plantar fascia stretching, and pain with pressure will be evaluated on an 11-point scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
4 secondary outcomes
Change in Activity-Related Pain Assessed by the Roles and Maudsley Score
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Foot Function Assessed by the Foot Function Index
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Ankle-Hindfoot Function Assessed by the American Orthopaedic Foot and Ankle Society Score
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile
Time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
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 Pulsed Radiofrequency Treatment and Ultrasound-Guided 5% Dextrose Injection in people with Chronic Plantar Fasciitis and Chronic Heel Pain, run by Ankara City Hospital Bilkent 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 13 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esra Ülgen Kıratlıoğlu, MD (+905079614194, esraulgen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heel Pain Intensity Assessed by Numeric Rating Scale (time frame: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.