Safety and Efficacy of the TransDiscal System Versus Medical Management in Treating Chronic Discogenic Low Back Pain (COLD)
2018年6月12日 更新者：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).
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
67
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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District of Columbia
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Washington、District of Columbia、アメリカ、20037
- George Washington University Hospital
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Florida
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Orlando、Florida、アメリカ、32806
- Compass Research
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Illinois
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Bloomington、Illinois、アメリカ、61701
- Millennium Pain Center
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Maryland
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Silver Spring、Maryland、アメリカ、20910
- Metro Orthopedics & Sports Therapy
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New Jersey
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Linwood、New Jersey、アメリカ、08221
- PainCare
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27103
- Center for Clinical Research
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Ohio
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic
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Texas
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Arlington、Texas、アメリカ、76018
- JPS Orthopedic & Sports Medicine
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Washington
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Seattle、Washington、アメリカ、98105
- Center for Pain Relief, University of Washington
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
21年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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他の：Medical Management
Standard medical management
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Standard medical management, physical therapy, and lifestyle changes.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Average Daily Pain Visual Analog Scale (VAS) Score Between Screening and Follow up.
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Percentage of Study Group Subjects With Greater Than 2 Points Decrease or 30% Drop in Average Daily Pain Related Visual Analog Scale (VAS) Score.
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Mean Change in Score of Oswestry Disability Index (ODI) Between Screening and 6 Month Follow up Visit
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：David Curd, MS、Halyard Health, Inc.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年12月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2015年4月1日
試験登録日
最初に提出
2010年11月29日
QC基準を満たした最初の提出物
2010年12月16日
最初の投稿 (見積もり)
2010年12月20日
学習記録の更新
投稿された最後の更新 (実際)
2018年7月10日
QC基準を満たした最後の更新が送信されました
2018年6月12日
最終確認日
2015年3月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。