Algovita Spinal Cord Stimulation System Hi-Fi Study
2021年3月9日 更新者：Nuvectra
Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.
調査の概要
状態
終了しました
条件
研究の種類
介入
入学 (実際)
20
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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Arizona
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Tucson、Arizona、アメリカ、85712
- Pain Institute of Southern Arizona
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California
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Newport Beach、California、アメリカ、92660
- Newport Beach Headache & Pain
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Santa Rosa、California、アメリカ、95401
- Summit Pain Alliance
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Colorado
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Colorado Springs、Colorado、アメリカ、80919
- Spinal Diagnostics & Pain Management
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Kansas
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Overland Park、Kansas、アメリカ、66210
- Mid-America PolyClinic & Interventional Pain Management Specialists
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Louisiana
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Shreveport、Louisiana、アメリカ、71105
- WK River Cities Clinical Research Center
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Massachusetts
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Chestnut Hill、Massachusetts、アメリカ、02467
- Brigham & Women's Hospital
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Ohio
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Chillicothe、Ohio、アメリカ、45601
- Adena Spine Center
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Cleveland、Ohio、アメリカ、44195
- Cleveland Clinic Foundation
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Rhode Island
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Providence、Rhode Island、アメリカ、02903
- Comprehensive Spine Center at Rhode Island Hospital
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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
18年～75年 (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:
- Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- Age 18-75 years old at consent.
- Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- ODI score of 41-80 out of 100 at the Baseline visit.
- Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
- Willing and capable of providing informed consent.
- Willing and able of complying with the study-related requirements, procedures, and visits.
- Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
Exclusion Criteria:
- Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- Has a condition currently requiring or likely to require the use of MRI or diathermy.
- Has an existing drug pump, SCS System, or other active implantable device.
- Has any prior SCS experience.
- Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
- For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
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：クロスオーバー割り当て
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
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Algovita Spinal Cord Stimulation System with associated components
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アクティブコンパレータ：Traditional pulse width
Traditional pulse width stimulation using the Algovita System
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Algovita Spinal Cord Stimulation System with associated components
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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 |
|---|---|---|
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Effectiveness of targeted pain reduction compared to baseline in each treatment arm
時間枠：Week 25
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The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods. |
Week 25
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Rate of serious study-related adverse events (AEs) in each treatment arm
時間枠：From Permanent Implant through Week 25
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The rate of serious study-related AEs.
Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
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From Permanent Implant through Week 25
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
時間枠：Week 12 and Months 12, 18 and 24
|
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
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Week 12 and Months 12, 18 and 24
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Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
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Weeks 12 and 25, and Months 12, 18 and 24
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Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in targeted, back and/or leg pain compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS).
The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in targeted, back and/or leg pain compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
|
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS).
The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable).
A higher score indicates a higher level of pain.
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Weeks 12 and 25, and Months 12, 18 and 24
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Clinician Global Impression of Change score in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in disability compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The change from baseline in disability as measured by the Oswestry Disability Index.
The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in quality of life compared to baseline in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in patient activity per the Pain Disability Index score in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The change from baseline in patient activity as measured by the Pain Disability Index score.
The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
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Weeks 12 and 25, and Months 12, 18 and 24
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Patient Global Impression of Change score in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
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Weeks 12 and 25, and Months 12, 18 and 24
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Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
時間枠：Weeks 12 and 25, and Months 12, 18 and 24
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Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
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Weeks 12 and 25, and Months 12, 18 and 24
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Evaluation of trial success rates
時間枠：From Trial Implant to End of Trail
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The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
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From Trial Implant to End of Trail
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Rate of surgical re-intervention of the SCS system
時間枠：From Permanent Implant through Month 24
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Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
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From Permanent Implant through Month 24
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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。
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 (実際)
2018年11月2日
一次修了 (実際)
2020年4月27日
研究の完了 (実際)
2020年4月27日
試験登録日
最初に提出
2018年7月26日
QC基準を満たした最初の提出物
2018年8月7日
最初の投稿 (実際)
2018年8月9日
学習記録の更新
投稿された最後の更新 (実際)
2021年3月11日
QC基準を満たした最後の更新が送信されました
2021年3月9日
最終確認日
2021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。
慢性の痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Ultra-high pulse width stimulationの臨床試験
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Science Valley Research Institute募集