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Comparing the Treatment Outcomes of Two Interventional Pain Procedures in Chronic Coccygodynia

21 maggio 2021 aggiornato da: Marmara University

Comparison of Treatment Outcomes in Chronic Coccygodynia Patients Treated With Ganglion Impar Blockade Versus Caudal Epidural Steroid Injection: A Prospective Randomized Comparison Study

Coccygodynia is a disabling pain in the coccyx exacerbated by sitting or rising from sitting. The pain is often pulling or lancinating in quality, may radiate to the sacrum or buttock, and may coexist with lower back pain. Contributing of many physiologic and psychological factors to its etiology, it may be traumatic or idiopathic in origin. Many risk factors are known such as trauma, female gender and obesity. Despite the identification of chronic coccygeal pain hundreds of years ago, its treatment can be difficult and sometimes controversial because of the multifactorial nature of coccygeal pain. Most cases of coccygodynia resolve within weeks to months with or without conservative treatment, but for a few patients, the pain can become chronic and debilitating. First-line treatment options include analgesic drugs, cushion, sit baths, and manuel therapy. Interventional procedures for pain management can be applied to patients who have no response to other conservative modalities. Ganglion impar block and caudal epidural steroid injection are two treatment options for chronic coccygodynia and both of them can be applied by guidance of fluoroscopy and ultrasonography. Radiofrequency ablation is the other option for treatment and eventually, surgical intervention can be done for patients who have refractory pain despite other treatments.

Although efficacy of two interventional procedure for chronic coccygodynia, ganglion impar block and caudal epidural steroid injection, has been well known, no study is exist comparing the efficacy of them. We aimed to compare the efficacy of ganglion impar block and caudal epidural steroid injection in chronic coccygodynia.

Panoramica dello studio

Descrizione dettagliata

The main purpose of this prospective study is the compare the efficacy of fluoroscopy-guided ganglion impar block and caudal epidural steroid injection in patients with chronic coccygodynia. Patients with chronic coccygeal pain are randomly divided into two groups based on the type of the interventional procedure: Group A, fluoroscopy-guided ganglion impar block group and, group B, fluoroscopy-guided caudal epidural steroid injection group. The patients who have chronic coccygeal pain not responding to other conservative treatments will be recruited from physical medicine&rehabilitation and pain medicine outpatient clinics. Detailed information including all aspects of interventional procedures will be given to patients, and inform consent will be obtained. Pain severity will be assessed using Numerical Rating Scale (NRS) as primary outcome. Quality of life and neuropathic pain component will be evaluated with Short Form-12 (SF-12) Questionnaire and Leeds Assessment of Neuropathic Symptoms&Signs Pain Scale (LANSS) as secondary outcomes, respectively. All assessments will be done at pre-interventional period, three weeks and three months after the procedure, with the exception of NRS, it will be also assessed at first hour post-procedure. All assessments will be done by clinician blinding the treatment groups.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

97

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Istanbul, Tacchino, 34899
        • Marmara University School of Medicine Department of Physical Medicine and Rehabilitation

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients diagnosed with chronic coccygodynia between the ages of 18 and 65
  • Intractable pain over the coccyx despite conservative treatment

Exclusion Criteria:

  • History of ganglion impar blockade and/or caudal epidural steroid injection carried out in the last 3 months
  • History of lumbar surgery
  • Systemic and/or local infections
  • Malignancy
  • Bleeding diathesis
  • Acute fracture
  • Known allergy to contrast material and/or local anesthetic substances
  • Known history of any psychiatric disorder
  • History of pregnancy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Ganglion impar block group
Fluoroscopy-guided ganglion impar block is applied to patients in this group.
Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Being most commonly used technic, transsacrococcygeal technique, a 22-gauge, 1.5-inch spinal needle is advanced through the sacrococcygeal disk and positioned carefully anterior to the sacrococcygeal junction. Injection of contrast results in a classical comma sign. A mixture of steroid and local anesthetic is given.
Comparatore attivo: Caudal epidural steroid injection group
Fluoroscopy-guided caudal epidural steroid injection is applied to patients in this group.
Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. An 18-gauge epidural needle (Tuohy) is advanced at an angle of 45° to the skin until a 'give-way' sensation is felt and position of the needle is confirmed by lateral and anteroposterior fluoroscopic images. Then 5 ml of iohexol solution is injected through it to confirm the position. A properly placed needle would produce a classical 'inverted fern tree' appearance in anteroposterior view after dye injection or a 'filling defect'. The needle is introduced up to S3 level for proper spread of the drug. A mixture of steroid and local anesthetics is given.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in pain severity of patients from baseline to each checkpoints
Lasso di tempo: from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month
Defining the change in Numeric Rating Scale (NRS) score
from pre-interventional time to post-interventional 1st hour, 3rd week, 3rd month

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in number of patients with neuropathic pain from baseline to each checkpoints
Lasso di tempo: from pre-interventional time to post-interventional 3rd week, 3rd month
Defining the change in number of patients with neuropathic pain using Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS)
from pre-interventional time to post-interventional 3rd week, 3rd month
Change the patient reported quality of life assessment from baseline to each checkpoints
Lasso di tempo: from pre-interventional time to post-interventional 3rd week, 3rd month
Defining the change in quality of life scores of patients using Short Form 12 Health Survey (SF-12)
from pre-interventional time to post-interventional 3rd week, 3rd month

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Savaş Şencan, MD, Marmara University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2019

Completamento primario (Effettivo)

1 gennaio 2021

Completamento dello studio (Effettivo)

1 marzo 2021

Date di iscrizione allo studio

Primo inviato

21 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2021

Primo Inserito (Effettivo)

26 maggio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

26 maggio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 maggio 2021

Ultimo verificato

1 maggio 2021

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 09.2019.395

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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