Intra-discal Steroid Injection for MODIC I Discopathy (PREDID)
Intra-discal Steroid Injection for MODIC I Discopathy: A Randomized Control Trial
To assess the efficacy on pain level at 1 month and 12 months of a steroid injection in the inter-vertebral disc for patients with chronic back pain and inflammatory discopathy on magnetic resonance imaging.
Hypothesis: delivering anti-inflammatory drugs in situ may decrease back pain in patients with inflammatory discopathy
調査の概要
詳細な説明
Objective: to assess the efficacy on pain level of a steroid injection in the inter-vertebral disc for patients with chronic back pain and MODIC I discopathy on MRI
Methods: a multicenter double blind randomized control trial Setting: 3 tertiary care hospitals in France Patients: 134 patients with disabling chronic low back pain not relieved by usual recommended treatments and MODIC I (inflammatory) discopathy on MRI Intervention: Injection of 25 mg of methylprednisolone in the inter-vertebral disc during a discography (intervention group, 67 patients) or discography alone (control group, 67 patients) Outcome measures: The primary outcome measure is pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month. Secondary outcome measures are pain level at 12 months, Disability (Quebec questionnaire), quality of life (SF-12) at 1 and 12 months, anxiety and depression (HAD), analgesics and anti-inflammatories during the last week, return to work, assessment of the disabilities at 1 and 12 months and disc inflammation (on MRI) at 12 months. Tolerance and adverse effects will be recorded.
Trial duration: 36 months(24 months for inclusion and 12 months follow-up) Follow-up visits: at 1, 3, 6, and 12 months Statistical analysis: intention to treat
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Paris、フランス、75014
- Hôpital Cochin
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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
説明
Inclusion criteria :
- More than 18 and less than 70 years old
- Low back pain
- Daily pain for at least 3 months
- Pain level during the last 48 hours > 40 on the numeric pain scale (0-100)
- Lack of efficacy of usual recommended treatments and of other spine steroid injections (epidural or facet joints injections)
- Modic I discopathy on MRI
- Intra-discal injection at least 6 months before inclusion
- Written informed consent
- Social security
- Medical examination
Non inclusion criteria :
- Pregnancy
- Hypersensitivity to methylprednisolone or contrast
- Local or general infection
- Previous disc surgery less than 6 months
- Steroid treatment
- Previous infectious spondylodiscitis
- Ankylosing spondylitis
- Sciatica with neurologic defects
- Uncontrolled psychiatric conditions
- Inability to read or understand French language
- Anti-vitamin K treatments
- Severe coagulation diseases
- Fever > 38 or sedimentation rate > 20
- Discopathy with MODIC 1 signal on several different lumbar stages
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
- 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：ダブル
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：Visipaque - Hydrocortancyl
Administration of two treatments for the experimental arm
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Visipaque 320 mg I/ml - 1 ml intra-discal route Hydrocortancyl 25 mg/ml - 1 ml intra-discal route
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プラセボコンパレーター：Visipaque
Administration of only one treatment in intra discal of visipaque
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Visipaque - 320 mg I/ml - 1 ml in intra-discal route
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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 |
時間枠 |
|---|---|
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Back pain level assessed on a 11-point numeric scale (0-100) at 1 month. Success is defined as less than 40 on pain numeric scale at 1 month
時間枠：1 month
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1 month
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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pain level at 12 months
時間枠：12 months
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12 months
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Disability (Quebec questionnaire)
時間枠：1 month and 12 months
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1 month and 12 months
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quality of life (SF-12) at 1 and 12 months
時間枠：1 month and 12 months
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1 month and 12 months
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anxiety and depression (HAD)
時間枠：1 month and 12 months
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1 month and 12 months
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disc inflammation (on MRI) at 12 month
時間枠：12 months
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12 months
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analgesics and anti-inflammatories during the last week
時間枠：1 month and 12 months
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1 month and 12 months
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return to work
時間枠：1 month and 12 months
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1 month and 12 months
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Assessment of the disabilities (scale of 6 classes)
時間枠：1 month and 12 months
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1 month and 12 months
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協力者と研究者
捜査官
- 主任研究者：Serge Poiraudeau, MD, PhD、Assistance Publique - Hôpitaux de Paris
出版物と役立つリンク
一般刊行物
- Nguyen C, Boutron I, Baron G, Sanchez K, Palazzo C, Benchimol R, Paris G, James-Belin E, Lefevre-Colau MM, Beaudreuil J, Laredo JD, Bera-Louville A, Cotten A, Drape JL, Feydy A, Ravaud P, Rannou F, Poiraudeau S. Intradiscal Glucocorticoid Injection for Patients With Chronic Low Back Pain Associated With Active Discopathy: A Randomized Trial. Ann Intern Med. 2017 Apr 18;166(8):547-556. doi: 10.7326/M16-1700. Epub 2017 Mar 21.
- Daste C, Abdoul H, Foissac F, Lefevre-Colau MM, Poiraudeau S, Rannou F, Nguyen C. Patient acceptable symptom state for patient-reported outcomes in people with non-specific chronic low back pain. Ann Phys Rehabil Med. 2022 Jan;65(1):101451. doi: 10.1016/j.rehab.2020.10.005. Epub 2020 Nov 26.
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
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- P070157
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背中の痛み 腰 慢性の臨床試験
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