Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (COLD)
12 de junho de 2018 atualizado por: 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).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
67
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20037
- George Washington University Hospital
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Florida
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Orlando, Florida, Estados Unidos, 32806
- Compass Research
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Illinois
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Bloomington, Illinois, Estados Unidos, 61701
- Millennium Pain Center
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Maryland
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Silver Spring, Maryland, Estados Unidos, 20910
- Metro Orthopedics & Sports Therapy
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New Jersey
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Linwood, New Jersey, Estados Unidos, 08221
- PainCare
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Center for Clinical Research
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Texas
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Arlington, Texas, Estados Unidos, 76018
- JPS Orthopedic & Sports Medicine
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Washington
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Seattle, Washington, Estados Unidos, 98105
- Center for Pain Relief, University of Washington
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
21 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: TransDiscal System
Kimberly-Clark TransDiscal System in addition to standard medical management
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Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
Outros nomes:
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Outro: Medical Management
Standard medical management
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Standard medical management, physical therapy, and lifestyle changes.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
Prazo: 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
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Mean Change in Score of Short Form 36-Physical Functioning (SF36-PF) From Screening to 6 Month Follow up Visit
Prazo: 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
|
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Mean Change in Score of EuroQuol 5d Visual Analog Scale (EQ-5d VAS) Between Screening and 6 Month Follow up Visit
Prazo: 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
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Mean Change in Score of Beck's Depression Inventory (BDI) Between Screening and 6 Month Follow up Visit
Prazo: 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
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Mean Change in Score of Patient Global Impression of Change (PGIC) Between Screening and 6 Month Follow up Visit
Prazo: 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.
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Baseline and 6 months
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Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
Prazo: 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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: David Curd, MS, Halyard Health, Inc.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2010
Conclusão Primária (Real)
1 de dezembro de 2014
Conclusão do estudo (Real)
1 de abril de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
29 de novembro de 2010
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de dezembro de 2010
Primeira postagem (Estimativa)
20 de dezembro de 2010
Atualizações de registro de estudo
Última Atualização Postada (Real)
10 de julho de 2018
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de junho de 2018
Última verificação
1 de março de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 100-10-0001
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