Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Pulsed Radiofrequency Versus 5% Dextrose Injection in Chronic Plantar Fasciitis

30 juni 2026 bijgewerkt door: Esra Ülgen Kıratlıoğlu, Ankara City Hospital Bilkent

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Esra Ülgen Kıratlıoğlu, MD
  • Telefoonnummer: +905079614194
  • E-mail: esraulgen@gmail.com

Studie Locaties

  • Turkije (Türkiye)
      • Ankara, Turkije (Türkiye)
        • Werving
        • Ankara Bilkent City Hospital, Physical Medicine and Rehabilitation Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ultrasound-Guided Pulsed Radiofrequency Treatment
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.
Procedure: Ultrasound-Guided Pulsed Radiofrequency Treatment
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.
Actieve vergelijker: Ultrasound-Guided 5% Dextrose Injection
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.
Procedure: Ultrasound-Guided 5% Dextrose Injection
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Heel Pain Intensity Assessed by Numeric Rating Scale
Tijdsspanne: 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.
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Activity-Related Pain Assessed by the Roles and Maudsley Score
Tijdsspanne: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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.
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Foot Function Assessed by the Foot Function Index
Tijdsspanne: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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.
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
Tijdsspanne: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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.
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
Change in Health-Related Quality of Life Assessed by the Nottingham Health Profile
Tijdsspanne: Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment
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.
Baseline, 3 weeks, 6 weeks, and 12 weeks after treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Ankara City Hospital Bilkent

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Geschat)

1 januari 2027

Studie voltooiing (Geschat)

1 januari 2027

Studieregistratiedata

Eerst ingediend

30 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 juni 2026

Eerst geplaatst (Werkelijk)

7 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • E2-26-14591

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren