Exploring Massage Benefits for Arthritis of the Knee (EMBARK)
2017年4月18日 更新者：Duke University
Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis
The purpose of this study is to verify the efficacy of an 8-week course of manualized Swedish massage for reducing pain and increasing function compared to light-touch bodywork, and usual care, in 222 adults with OA of the knee.
調査の概要
研究の種類
介入
入学 (実際)
222
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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Connecticut
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Derby、Connecticut、アメリカ、06418
- Yale-Griffin Prevention Research Center, Integrative Medicine Center at Griffin Hospital
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New Jersey
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Morristown、New Jersey、アメリカ、07960
- Atlantic Health System -- Atlantic Health Integrative Medicine
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North Carolina
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Durham、North Carolina、アメリカ、27710
- Duke University Medical Center- Duke Integrative Medicine
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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
35年歳以上 (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:
- 35 years of age or greater.
- Written confirmation of OA of the knee as provided by the participant's physician.
- Radiographically-established OA of the knee.
- Pre-randomization rating within a certain range on the Visual Analog Pain Scale (0 - 100 mm scale).
- Receiving care for diagnosed OA of the knee under the care of a board-certified primary care physician, with or without involvement of a board-certified rheumatologist.
- Patients with bilateral knee involvement will have the more severely affected knee designated as the study knee.
American College of Rheumatology defined OA of the knee; specifically:
a. Knee pain b. Satisfaction of at least three of the following six criteria: i. Age great than 50 years ii. Stiffness < 30 minutes iii. Crepitus iv. Bony Tenderness v. Bony enlargement vi. No palpable warmth
Exclusion Criteria:
- Presence of rheumatoid arthritis, fibromyalgia, recurrent or active pseudo gout.
- Presence of cancer or other decompensated medical conditions that limit the ability to participate fully in all interventions, assessments, and follow-up visits.
- Signs or history of kidney or liver failure.
- Presence of asthma requiring the use of corticosteroid treatment.
- Use of oral corticosteroids within the past four weeks.
- Use of intra-articular knee depo-corticosteroids with the past three months.
- Use of intra-articular hyaluronate with the past six months.
- Arthroscopic surgery of the knee within the past year.
- Significant injury to the knee within the past six months.
- Presence of a rash or open wound over the knee.
- Unable to satisfy the treatment and follow-up requirements.
- Unable to provide written informed consent.
- Currently receiving massage therapy on a regular basis (at least twice a month).
- Knee replacement of study knee (ok if the knee not being studied has been replaced).
- History of participating in the EMBARK Phase I or II studies.
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：他の
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
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：Swedish Massage
Swedish massage for one hour, once per week, for eight weeks.
At week 10, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), and 50% will be randomized to Usual Care.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
他の名前：
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アクティブコンパレータ：Light Touch Bodywork
Light-touch bodywork for one hour, once per week, for eight weeks.
At week 10, 50% of the patients will be randomized to a maintenance dose (one hour of light-touch massage every two weeks, and 50% will be randomized to Usual Care.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
他の名前：
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他の：Usual Care
Those initially randomized to the usual care control will be rolled into the Swedish massage intervention (one hour of Swedish massage, once/week for eight weeks) at week 25.
At week 34, 50% of patients will be randomized to a maintenance dose (one hour of Swedish massage every two weeks), while 50% will be randomized back to Usual Care.
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Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
他の名前：
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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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Change in Western Ontario and McMaster Universities Osteoarthritis of the Knee and Hip Index (WOMAC)
時間枠：Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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The Index is self-administered and assesses the three dimensions of pain, disability and joint stiffness in knee and hip osteoarthritis through 24 questions.
WOMAC 3.1 is available in 65 languages using either a five-point Likert scale or a 100 mm visual analog scale.
The WOMAC has been subject to numerous validation studies to assess reliability and responsiveness to change in therapy, including physical forms of therapy
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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 |
|---|---|---|
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Change in Pain: The Visual Analog Scale (VAS)
時間枠：Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Used to measure pain sensation intensity evoked by nociceptive stimuli.
Subjects quickly and easily rate stimuli within the series by indicating level of pain on a 100 mm scale.
Pain intensity is represented by the participant drawing a line on the scale indicative of pain experienced (0 = no pain, to 100 = worse pain imaginable).
The VAS is anchored at the left by "no pain sensation" and at the right by "the most intense pain sensation imaginable."
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Pain: PROMIS Pain Interference Questionnaire
時間枠：Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Patient Reported Outcomes Measurement Information System (PROMIS), funded by the National Institutes of Health (NIH), is a system of highly reliable, valid, flexible, precise, and responsive assessment tools that measure patient-reported health status.
The Pain Interference Questionnaire has 6 questions answered on an ordinal scale of five gradations.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Joint Flexibility
時間枠：Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Joint flexibility is defined as the range of motion (ROM) allowed at the knee.
The knee's ROM is measured by the number of degrees from the starting position of a segment to its position at the end of its full range of the movement.
This is measured using a double-armed goniometer.
A stationary arm holding a protractor is placed parallel with a stationary body segment and a movable arm moves along a moveable body segment.
The pin (axis of goniometer) is placed over the joint.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Change in Physical Function
時間枠：Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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Measured time in seconds to walk fifty (50) feet (15 m) on a level surface within the clinic facilities.
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Baseline, 8, 16, 24, 36 and 52 weeks (Baseline, 8, 16, 24, 32, 40 and 48 for Usual Care group)
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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。
スポンサー
捜査官
- 主任研究者：Adam Perlman, MD, MPH、Duke University
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Perlman AI, Sabina A, Williams AL, Njike VY, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized controlled trial. Arch Intern Med. 2006 Dec 11-25;166(22):2533-8. doi: 10.1001/archinte.166.22.2533.
- Perlman AI, Ali A, Njike VY, Hom D, Davidi A, Gould-Fogerite S, Milak C, Katz DL. Massage therapy for osteoarthritis of the knee: a randomized dose-finding trial. PLoS One. 2012;7(2):e30248. doi: 10.1371/journal.pone.0030248. Epub 2012 Feb 8.
- Perlman A, Fogerite SG, Glass O, Bechard E, Ali A, Njike VY, Pieper C, Dmitrieva NO, Luciano A, Rosenberger L, Keever T, Milak C, Finkelstein EA, Mahon G, Campanile G, Cotter A, Katz DL. Efficacy and Safety of Massage for Osteoarthritis of the Knee: a Randomized Clinical Trial. J Gen Intern Med. 2019 Mar;34(3):379-386. doi: 10.1007/s11606-018-4763-5. Epub 2018 Dec 12.
便利なリンク
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
2012年6月1日
一次修了 (実際)
2015年6月1日
研究の完了 (実際)
2015年6月1日
試験登録日
最初に提出
2012年2月7日
QC基準を満たした最初の提出物
2012年2月17日
最初の投稿 (見積もり)
2012年2月23日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月20日
QC基準を満たした最後の更新が送信されました
2017年4月18日
最終確認日
2015年8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。
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