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Landmark-Guided Dextrose Prolotherapy for Coccydynia: A Retrospective Study

27 de abril de 2026 actualizado por: Yunus Emrah Koşut, Gaziosmanpasa Research and Education Hospital

Evaluation of the Effectiveness of Landmark-Guided (Blind) Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Retrospective Study

Coccydynia is a musculoskeletal pain condition that can lead to chronic pain and functional impairment, significantly affecting quality of life. Although conservative treatment is effective in many cases, the number of patients with refractory symptoms appears to be increasing, highlighting the need for effective and accessible treatment options.

Prolotherapy is a regenerative injection therapy that aims to stimulate tissue healing and reduce pain through the modulation of nociceptive signaling, most commonly using dextrose solutions.

This retrospective study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who underwent prolotherapy to coccygeal ligaments between January 1, 2024, and June 1, 2025, with a treatment protocol consisting of 3-6 sessions administered at 3-week intervals using a 15% dextrose solution.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Coccydynia is a musculoskeletal pain condition characterized by pain localized to the coccygeal region, often leading to chronic pain and functional impairment that negatively affects quality of life. Although conservative treatment is effective in many patients, a growing number of cases remain refractory, highlighting the need for alternative therapeutic approaches.

Prolotherapy is a regenerative injection technique increasingly used in chronic musculoskeletal pain conditions. It aims to stimulate tissue repair and modulate nociceptive signaling through the administration of proliferant solutions, most commonly hypertonic dextrose. By inducing a controlled inflammatory response, prolotherapy is thought to promote fibroblast activity, collagen synthesis, and strengthening of ligamentous structures.

This retrospective cohort study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain severity and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who presented to the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025, with coccydynia persisting for at least 3 months and refractory to conservative treatment.

Eligible patients received prolotherapy injections targeting the coccygeal ligaments using anatomical reference points without ultrasound guidance. A 15% dextrose solution was administered in 3 to 6 sessions at 3-week intervals according to a standardized treatment protocol.

Pain severity and functional status were assessed using the Visual Analog Scale (VAS) and the Dallas Pain Questionnaire (DPQ), respectively. Outcome measures were evaluated at baseline (pre-treatment) and at follow-up after completion of the treatment protocol.

A minimum sample size of 30 patients was determined, and a total of 50 patients were included in the study.

Tipo de estudio

De observación

Inscripción (Actual)

50

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Istanbul, Turquía (Türkiye)
        • Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, 34255

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

The study population consists of patients aged 18 to 75 years diagnosed with mechanical or idiopathic coccydynia, with symptoms persisting for at least 3 months and refractory to conservative treatment, who underwent landmark-guided (blind) dextrose prolotherapy at the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025.

Descripción

Inclusion Criteria:

  • Age between 18 and 75 years
  • Diagnosis of mechanical or idiopathic coccydynia
  • Pain persisting for at least 3 months
  • Refractory to conservative treatment

Exclusion Criteria:

  • Pregnancy
  • Allergy to the proliferant solution
  • Active infection
  • Use of anticoagulant medications
  • Presence of malignancy
  • Local abscess
  • Documented hemorrhagic diathesis
  • Certain types of septic arthritis
  • Parafunctional habits

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Landmark-Guided Dextrose Prolotherapy
This cohort includes patients with mechanical or idiopathic coccydynia who underwent landmark-guided (blind) dextrose prolotherapy using a 15% dextrose solution. Injections were performed to the coccygeal ligamentous structures based on anatomical reference points without ultrasound guidance.
Landmark-guided (blind) prolotherapy was performed using a 15% dextrose solution under sterile conditions. The procedure was carried out based on anatomical reference points without ultrasound guidance. The coccygeal and sacrococcygeal ligamentous structures were targeted, and injections were administered to 3-4 periosteal insertion points using a 27G needle. A maximum of 0.5 mL was injected per site, with a total volume not exceeding 2-2.5 mL per session. The treatment protocol consisted of 3 to 6 sessions performed at 3-week intervals.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Visual Analog Scale (VAS)
Periodo de tiempo: Baseline and 1 month after completion of treatment
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
Baseline and 1 month after completion of treatment

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Dallas Pain Questionnaire (DPQ)
Periodo de tiempo: Baseline and 1 month after completion of treatment
The Dallas Pain Questionnaire (DPQ) is a validated instrument that evaluates the impact of chronic pain on functional status across four domains: daily activities, work and leisure activities, anxiety/depression, and social interest. Scores range from 0 to 100, with higher scores indicating greater functional limitation and a higher degree of pain-related impairment, whereas lower scores reflect better functional capacity and lower levels of impairment.
Baseline and 1 month after completion of treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Merve Dikici Yagli, Gaziosmanpasa Educational and Training Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

15 de enero de 2026

Finalización primaria (Actual)

15 de marzo de 2026

Finalización del estudio (Actual)

15 de marzo de 2026

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

27 de abril de 2026

Publicado por primera vez (Actual)

4 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

27 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 01 (Leona M. and Harry B. Helmsley Charitable Trust)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .