Manipulation, Exercise, and Self-Care for Low Back Pain
調査の概要
詳細な説明
Low back pain remains an important public health problem with serious socioeconomic consequences. Despite the considerable amount of research that has been preformed, there is still a dire need for randomized clinical tiles of high methodological quality. The broad, long-term objective of this interdisciplinary research is to identify effective therapies for low back pain sufferers and increased understanding of this important condition. Building upon the principal investigators' previous collaborative research, this randomized observer-blinded clinical trial will compare the following treatment for patients with nonacute low back pain:
- chiropractic spinal manipulation
- rehabilitative exercise
- self care education Theprimary aim is to examine the relative efficacy of the three interventions in terms of patient rated outcomes in the short-term (after 12 weeks) and the long-term (after 52 weeks) for nonacute low back pain.
Secondary aims include:
- To examine the short and long-term relative cost effectiveness and cost utility of the three treatments.
- To assess if there are clinically important differences between pre-specified subgroups of low back pain patients. Subgroups are based on duration and current episode and radiating leg pain.
- To evaluate if there treatment group differences in objective lumbar spine function (range of motion, strength and endurance) after 12 weeks of treatment and if changes in lumbar function are associated with changes in patient rated short and long-term outcomes.
- To identify if baseline demographic or clinical variables can predict short or long-term outcome.
- To describe patients' interpretations and perceptions of outcome measures used in clinical trials.
研究の種類
入学
段階
- フェーズ2
連絡先と場所
研究場所
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Minnesota
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Bloomington、Minnesota、アメリカ、55431
- Northwestern Health Sciences University
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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: patients are 18-65 years of age; Québec task force classification 1,2,3 and 4 (this includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs); primary complaint of back pain, with current episode greater than or equal to six weeks duration(this includes subacute and chronic patients for whom the study treatments are an option)
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Exclusion Criteria:
- previous lumbar spine surgery; back pain referred from local joint lesions of the lower extremities or from visceral diseases; progressive neurological deficits due to nerve root or spinal cord compression; aortic and peripheral vascular disease; existing cardiac disease requiring medical treatment; blood clotting disorders; diffuse idiopathic hyperostosis; infectious and noninfectious inflammatory or destructive tissue changes of the lumbar spine; presence of significant infectious disease, or other severe debilitating health problems; substance abuse; ongoing treatment for back pain by other health care providers; pregnant or nursing women; pain score of less than 30 percentage points; pending our current litigation
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:独身
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 |
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Pain (Visual Analog Scale) at baseline, weeks 4,12,26,52
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二次結果の測定
結果測定 |
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Disability (Modified Roland Scale) at baseline, weeks 4,12,26,52
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General Health (SF-36) at baseline, weeks 4,12,26,52
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Improvement (7 point scale) at baseline, weeks 4,12,26,52
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Disability (NHIS) at baseline, weeks 4,12,26,52
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Bothersomeness (7 point scale) at baseline, weeks 4,12,26,52
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Frequency (7 point scale) at baseline, weeks 4,12,26,52
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Satisfaction (5 point scale) at baseline, weeks 4,12,26,52
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Depression (CES-D) at baseline, weeks 4,12,26,52
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Medication use at baseline, weeks 4,12,26,52
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Fear-avoidance (FABQ) at baseline, weeks 4,12,26,52
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Lumbar range of motion at baseline, weeks 4,12,26,52
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Lumbar strength and endurance at baseline, weeks 4,12,26,52
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Health care costs and utilization at baseline, weeks 4,12,26,52
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Haanstra TM, Hanson L, Evans R, van Nes FA, De Vet HC, Cuijpers P, Ostelo RW. How do low back pain patients conceptualize their expectations regarding treatment? Content analysis of interviews. Eur Spine J. 2013 Sep;22(9):1986-95. doi: 10.1007/s00586-013-2803-8. Epub 2013 May 10.
- Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH Jr, Owens EF Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011 Jul;11(7):585-98. doi: 10.1016/j.spinee.2011.01.036. Epub 2011 May 31.
便利なリンク
研究記録日
主要日程の研究
研究開始
研究の完了
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
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
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen Universityまだ募集していません
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Dexa Medica Group完了
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Daiichi Sankyo募集
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Daiichi Sankyo完了
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Université Victor Segalen Bordeaux 2Nanox International Laboratory (Belgique)完了
エクササイズの臨床試験
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University of Erlangen-Nürnberg Medical SchoolKlinikum Nürnberg完了
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Shanghai Jiao Tong University School of Medicine積極的、募集していない
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University of TorontoUniversity Health Network, Toronto; University of Western Ontario, Canada; Institute for Clinical... と他の協力者完了