Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
調査の概要
詳細な説明
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
研究の種類
入学 (実際)
段階
- 初期フェーズ 1
連絡先と場所
研究場所
-
-
Florida
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Gainesville、Florida、アメリカ、32607
- UF & Shands Orthopaedics and Sports Medicine Institute
-
-
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:
- Low back pain episode greater than six months in duration
- NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- Previous medial branch block providing >80% pain relief for current painful episode
- Subject must be scheduled to undergo a second medial branch block for their back pain
Exclusion Criteria:
- Litigation
- Those seeking new or increased long-term remuneration
- Leg pain greater than back pain
- Radicular pain or evidence of neurological compromise in the lower limbs
- Those unable to read English and complete the assessment instruments
- Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
- Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
- Significant lower extremity pathology that affects gait
- Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
- Possible pregnancy or other reason that precludes the use of fluoroscopy
- Significant scoliosis
- Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
- Contra-indication to corticosteroid, including known allergies or sensitivities
- History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
アクティブコンパレータ:Intra-articular corticosteroid injection
Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
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プラセボコンパレーター:Intra-articular saline injection
Intra-articular saline injections with confirmatory anesthetic medial branch blocks
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Intra-articular injection of 0.5 cc normal saline in each joint
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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 |
---|---|---|
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
時間枠:Hourly for 6 hours post injections
|
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
|
Hourly for 6 hours post injections
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Numeric Pain Rating (NPR) Daily diary
時間枠:reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
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reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
Oswestry Disability Index (ODI)
時間枠:6 weeks, 3 months, 6 months, 12 months
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Patient will complete ODI at the follow-up intervals.
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6 weeks, 3 months, 6 months, 12 months
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Standard Form 36 (SF-36), General Health Survey
時間枠:6 weeks, 3 months, 6 months, 12 months
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Patient will complete the SF-36 at the follow-up intervals.
The SF-36 is a self-administered, generic, general health survey consisting of 36 questions.
The questions focus on the functional health and well being of the subject completing the form.
|
6 weeks, 3 months, 6 months, 12 months
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Daily Work History Log
時間枠:reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
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Patient will keep a Work History Log during participation.
The Log should indicate the daily work activities of the subject.
|
reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
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Daily Analgesic Use Log
時間枠:reviewed at 6 weeks, 3 months, 6 months, 12 months
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Patient will keep a Daily Analgesic Use Log during participation.
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reviewed at 6 weeks, 3 months, 6 months, 12 months
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Ancillary Treatment Log
時間枠:reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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Patient will keep an Ancillary Treatment Log during participation.
This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.
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reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:D. J. Kennedy, M.D.、UF Department of Orthopaedics and Rehabilitation
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 (見積もり)
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
その他の研究ID番号
- 319-2010
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
腰痛の臨床試験
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityまだ募集していません
-
Dexa Medica Group完了
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Daiichi Sankyo募集
-
Daiichi Sankyo完了
-
Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完了
Intra-articular corticosteroid injectionの臨床試験
-
Procare Health Iberia S.L.完了変形性関節症、股関節 | 変形性関節症 親指 | 変形性関節症 足首スペイン