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Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (COLD)

12 giugno 2018 aggiornato da: Halyard Health

A Prospective, Randomized, Multi-Center, Open-Label Clinical Trial Comparing Disc Biacuplasty With Medical Management for Discogenic Lumbar Back Pain

The primary objective of this randomized controlled trial is to evaluate the safety and efficacy of the TransDiscal System (TDS) in treating discogenic pain of the lumbar spine using a modified disc biacuplasty procedure. The primary efficacy measure will be the Visual Analog Scale (VAS) at 6 months post treatment/randomization and the TransDiscal System will be compared against medical management (standard of care).

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The intervertebral discs serve as joints between the vertebral bodies, providing both structural support and flexibility to the spinal column. Intervertebral discs do not remain structurally intact over a lifetime and degenerate as a natural part of aging. Degenerated discs do not react to stresses and forces the same as healthy discs. When too much stress is applied to a degenerated disc, tears can result. Evidence suggests that when a tear is present, sensory nerve endings can grow into the tear and transmit pain.

The TransDiscal System (TDS) is a medical device that is used in a procedure called Disc Biacuplasty and is currently available in the United States and throughout the world. The TDS enables the back of the disc to be heated to high enough temperatures to ablate the nerves inside that are transmitting pain, while maintaining low enough temperatures to prevent damage to surrounding tissues. The TDS uses two electrodes, located at the ends of two thin probes, which are placed on both sides of the back of the intervertebral disc by inserting them through the skin into the disc using x-ray guidance. Radiofrequency (RF) current flows in the disc between the two electrodes, heating the tissue in the disc to the desired temperature. The study evaluates a modified heating protocol than what is currently in clinical use which should allow for a larger area of the back of the disc to be heated.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

67

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

  • Stati Uniti
    • District of Columbia
      • Washington, District of Columbia, Stati Uniti, 20037
        • George Washington University Hospital
    • Florida
      • Orlando, Florida, Stati Uniti, 32806
        • Compass Research
    • Illinois
      • Bloomington, Illinois, Stati Uniti, 61701
        • Millennium Pain Center
    • Maryland
      • Silver Spring, Maryland, Stati Uniti, 20910
        • Metro Orthopedics & Sports Therapy
    • New Jersey
      • Linwood, New Jersey, Stati Uniti, 08221
        • PainCare
    • North Carolina
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Center for Clinical Research
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic
    • Texas
      • Arlington, Texas, Stati Uniti, 76018
        • JPS Orthopedic & Sports Medicine
    • Washington
      • Seattle, Washington, Stati Uniti, 98105
        • Center for Pain Relief, University of Washington

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

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Age ≥21 years
  • Able to understand the informed consent and able to complete outcome measures
  • Objective measurements indicating functional impairment related to low back pain
  • Stabilized on pain medication regimen for >2 months as defined by a <10% change in dosage
  • History of chronic low back pain (>6 months) unresponsive to non-operative care (including physical therapy, anti-inflammatory medication, epidurals, diagnostic facet joint/medial branch blocks, and sacroiliac joint interventions as performed or deemed appropriate by the Investigator)
  • Score ≥5 on the Visual Analog Scale (VAS) relating specifically to the average daily low back pain
  • Back pain more prominent than leg pain which is commonly exacerbated by flexion or bending or prolonged sitting.
  • Single level concordant pain reproduction present on lumbar discography in desiccated disc. Magnetic resonance Imaging (MRI) image also supports discography findings. Changes in other disc spaces in the lumbar region do not demonstrate neural compressive lesion.
  • Disc height at least 50% of adjacent control disc

Exclusion Criteria:

  • Evidence of compressive radiculopathy with predominant leg pain
  • Evidence of nucleus pulposus herniation or free disc fragments on MRI
  • Evidence of > 2 discs dessicated based on MRI or symptomatic involvement of more than one lumbar disc levels.
  • Asymptomatic disc bulges > 5 mm at the treatment level.
  • Prior lumbar surgery of any kind at the treatment level (micro-discectomies, and/or minimally invasive procedures at other levels that are not excluded)
  • Prior spinal fusion below the T10 Level
  • Symptoms or signs of lumbar canal stenosis at any level
  • Evidence of structural abnormality at the lumbar level (except non-symptomatic spondylolysis resulting in spondylolithesis no more than Grade 1 upon flexion and extension)
  • Any generalized pain or multifocal pain,conversion or multiple non-anatomical complaints
  • Pending or active compensation claim, litigation or disability income remuneration (secondary gain)
  • Chronic pain associated with significant psychosocial dysfunction
  • Beck's Depression Index (BDI) score >20
  • Current pregnancy, recent delivery (within 3 months of consent) or the intent of becoming pregnant during the study period.
  • Systemic or localized infection at the anticipated needle entry site (subject may be considered for inclusion once infection is resolved)
  • Discitis
  • Allergies to any medication to be used in the procedure
  • Present symptomatic lumbar spinal fracture
  • History of uncontrolled coagulopathy, ongoing coagulation treatment or unexplained or uncontrollable bleeding that is uncorrectable
  • Progressive neurological deficits
  • Within the preceding 2 years, subject has suffered from active narcotic addiction, substance abuse or alcohol abuse
  • Current prescribed opioid medications equivalent to >120 mg of morphine per 24 hours
  • Uncontrolled immunosuppression (e.g. Acquired Immune Deficiency Syndrome [AIDS], cancer, diabetes, etc.)
  • Body Mass Index (BMI) >32.5 kg/m^2
  • Participating in another clinical trial/investigation 30 days prior to signing informed consent
  • Negative or indeterminate lumbar discography results as assessed per International Spine Intervention Society (ISIS) guidelines
  • Subject unwilling or unable to comply with follow up schedule or protocol requirements.

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: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TransDiscal System
Kimberly-Clark TransDiscal System in addition to standard medical management
Dispositivo: TransDiscal System
Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Altri nomi:
  • TransDiscal,disc biacuplasty,disc,ablation,low back pain
Altro: Medical Management
Standard medical management
Altro: Medical Management
Standard medical management, physical therapy, and lifestyle changes.
Altri nomi:
  • physical therapy, medications,

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
Lasso di tempo: Baseline and 6 months
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
Lasso di tempo: Baseline and 6 months
Visual Analog Scale (NRS) - score range = 0 - 10. "0" corresponds to "no pain" and "10" indicates "worst pain imaginable". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months
Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
Lasso di tempo: Baseline and 6 months
Short Form 36-PF - score range = 0 - 100. "0" corresponds to "greatest disability" and "100" indicates "no disability". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months
Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
Lasso di tempo: Baseline and 6 months
EQ-5d VAS - score range = 0 - 100. "0" corresponds to the "worst imaginable health state" and "100" indicates the "best imaginable health state". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months
Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
Lasso di tempo: Baseline and 6 months
BDI - score range = 0 - 63. "0" corresponds to "minimal depression" and "63" indicates "severe depression". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months
Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
Lasso di tempo: Baseline and 6 months
PGIC - score range = 1 - 7. "1" corresponds to "very much improved" and "7" indicates "very much worse" pertaining to overall activity, symptoms, emotions, and quality of life. The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 months
Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
Lasso di tempo: Baseline and 6 Months
ODI - score range = 0 - 100. "0" corresponds to "no disability" and "100" indicates the "maximum disability possible". The means of these scores and their respective standard deviations are reported for each study group.
Baseline and 6 Months

Collaboratori e investigatori

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

Sponsor

Halyard Health

Investigatori

  • Direttore dello studio: David Curd, MS, Halyard Health, Inc.

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

1 dicembre 2010

Completamento primario (Effettivo)

1 dicembre 2014

Completamento dello studio (Effettivo)

1 aprile 2015

Date di iscrizione allo studio

Primo inviato

29 novembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

16 dicembre 2010

Primo Inserito (Stima)

20 dicembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 luglio 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 giugno 2018

Ultimo verificato

1 marzo 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 100-10-0001

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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