A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region (BINGO)
BINGO: A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region
調査の概要
研究の種類
入学 (実際)
連絡先と場所
研究場所
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-
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Goteborg、スウェーデン
- Sahlgrenska Universitetssjukhuset
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Uppsala、スウェーデン
- Akademiska sjukhuest
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Subject is at least 18 years old
- Subject is able and willing to comply with the follow-up schedule and protocol
- Chronic, intractable pain for at least 6 months
- Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain
- Minimum baseline pain rating of 60 mm on the VAS in the primary region of pain
- Subject is able to provide written informed consent
Exclusion Criteria:
- Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration
- Escalating or changing pain condition within the past month as evidenced by investigator examination
- Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days
- Subject has had radiofrequency treatment of an intended target DRG within the past 3 months
- Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- Subject is unable to operate the device
- Subjects currently has an active infection
- Subject has participated in another clinical investigation within 30 days
- Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- Subject has been diagnosed with cancer in the past 2 years.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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治療対象
Axium神経刺激装置で募集および治療されたすべての被験者
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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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Pain Intensity in Primary Region of Pain
時間枠：Post treatment at 3, 6 and 12 months
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Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain). |
Post treatment at 3, 6 and 12 months
|
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Pain Intensity in Overall Pain
時間枠：Post treatment at 3, 6 and 12 months
|
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain). |
Post treatment at 3, 6 and 12 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。