A Study To Evaluate Methods To Evaluate Back Pain
2013年2月21日 更新者：Wyeth is now a wholly owned subsidiary of Pfizer
A Pilot Study To Evaluate Various Methodologies For Assessing The Treatment Of Low Back Pain
The study is designed to assess methods used in clinical research.
調査の概要
研究の種類
介入
入学 (実際)
61
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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California
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Loma Linda、California、アメリカ、92350
- Pfizer Investigational Site
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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
18年～55年 (大人)
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:
- Lower back pain
- Male or female in generally good health, from 18 to 55 years of age (inclusive)
Exclusion Criteria:
- Pregnant or lactating
- Subject has evidence or history of radiculopathy, i.e. sciatica extending below the knee (numbness, tingling, or shooting pain), or other neurologic deficits (abnormal straight leg raise test, patellar reflexes, and/or bowel and bladder function);
- Subject has a history of previous back surgery;
- Subject has back pain resulting from traumatic injury involving physical evidence of bruising, swelling, or inflammation to the abdomen or low back area which occurred less than 48 hours prior to enrollment
- Has taken an investigational drug within the past 30 days prior to entering the study, or currently enrolled in another investigational study
- Is a member or relative of the study site staff, CRO or Sponsor organization directly involved with the study or had a household member or relative participate concurrently or previously in this study
- Has previously been enrolled in this study
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：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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：1
Heat device
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8-Hour Heatwrap
他の名前：
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偽コンパレータ：2
Placebo arm
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Inactive wrap worn for 8 hours
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アクティブコンパレータ：3
Marketed analgesic
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2 x 200 mg ibuprofen tablets
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プラセボコンパレーター：4
(Oral) Placebo comparator
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2 x placebo tablets
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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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Time to First Perceptible Relief (Confirmed by Meaningful Relief)
時間枠：Baseline (time of wrap application or oral treatment administration) up to 4 hours
|
"First perceptible relief" defined as the elapsed time from wrap application or oral treatment until the participant depressed the first stopwatch labeled "first perceptible relief" (any pain relieving effect), provided the participant also depressed the second stopwatch labeled "meaningful relief" (meaningful to participant) by the end of the scheduled in-patient evaluation (4 hours / 240 minutes).
If the confirmation was not achieved, the participant was censored at the time when the first stopwatch was depressed.
Confidence interval (CI) calculated using the method of Simon & Lee.
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Baseline (time of wrap application or oral treatment administration) up to 4 hours
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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 |
|---|---|---|
|
Time to Meaningful Relief
時間枠：Baseline (time of wrap application or oral treatment administration) up to 4 hours
|
Time to "meaningful relief" defined as elapsed time from start of treatment until participant depressed the second stopwatch indicating "meaningful relief" (meaningful to participant).
Participant consider censored if participant did not depress the stopwatch by end of 4-hour in-patient evaluation, or became a treatment failure (rescue or discontinuation) during the time prior to depressing the second stopwatch.
Censoring was at time of dropout if participant withdrew for non-efficacy related reasons during the 4-hour in-patient portion of the study.
CI calculated using method of Simon & Lee.
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Baseline (time of wrap application or oral treatment administration) up to 4 hours
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Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)
時間枠：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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TOTPAR 0-8 sum of pain relief from 0 through 8 hours, weighted by the time duration between the current timepoint and the previous timepoint.
Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.
Total possible score 0 to 40; higher score indicated better relief.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours
時間枠：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time weighted sum of change calculated as sum of change from baseline in back stiffness scores from 0 through 8 hours, weighted by time duration between current timepoint and previous timepoint.
Based on hourly (from baseline) back stiffness assessment rating from 0 (no muscle stiffness) to 100 (most possible muscle stiffness).
Sum of change derived by subtracting score at post-dosing time point from baseline score.
Total possible score -800 to 800; higher positive value was indicative of greater improvement.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time to Treatment Failure
時間枠：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Time to treatment failure defined as time from dosing to the time of rescue medication within the scheduled duration of the study (8 hours); or for participants who withdrew from the study due to lack of efficacy without taking rescue medication, the time of the last assessment was considered the time to treatment failure; or if participant did not take rescue medication, or did not discontinue due to lack of efficacy, the time to treatment failure was considered censored at 8 hours (the scheduled duration of the study).
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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Individual Time-Point Pain Relief Scores
時間枠：At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Pain relief rated hourly (from baseline) by the participant on a 6-point scale: 0=no relief, 1=a little relief, 2=less than half relief, 3=more than half relief, 4=a lot of relief, 5=complete relief.
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At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Change From Baseline in Individual Time-point Back Stiffness Scores
時間枠：At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Low back muscle stiffness rated hourly (from baseline) by the participant by placing a line on a visual analog scale (VAS) from 0 millimeters (mm) to 100 mm in length with 0=no muscle stiffness up to 100 (most possible stiffness).
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At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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Change From Baseline (Bsl) in Combined Flexibility Score: Extension
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement.
Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees minus 5, and x degrees plus 5. Flexibility score derived using standardized value and VAS score (participant rating of pain by marking level of pain on 100 mm line 0=no pain up to 100=worst pain).
Final derived data for extension flexibility were average of the extension flexibility data on the combined score (range -66 to 552); higher value indicated greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus (+/-) 10 degrees for left, and right (L, R), movement.
Angle at Bsl and 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain to 100=worst pain).
Final derived data for overall flexibility was the average of side-to-side (L, R) flexibility data on the combined score (range -81 to 264); higher value=greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus (+/-) 30 degrees for left, and right (L, R), movement.
Angle at Bsl and at 4 hours standardized to 100 for assessment of maximum angle (x degrees), x degrees - 5, and x degrees + 5. Flexibility score derived using standardized value and VAS score (participant rating of level of pain on 100 mm line 0=no pain up to 100=worst pain).
Final derived data for overall flexibility were the average of rotation (L, R) flexibility data on combined score (range -80 to 155); higher value=greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement of 20 degrees for extension (as if performing a sit-up) to the degree of movement at which participant perceives discomfort or pain.
Higher score indicated greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum movement +/- 10 degrees for left, and right, side-to-side movement to the degree of movement at which participant perceives discomfort or pain.
Maximum flexion based on the average of the left and right side-to-side scores.
Higher score indicated greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
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Participant placed in a prone position on Paris Plinth table which is moved at 1 degree per second to maximum rotation at waist of +/- 30 degrees for left, and right, movement to the degree of movement at which participant perceives discomfort or pain.
Maximum flexion based on the average of the left and right rotation scores.
Higher score indicated greater improvement.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
|
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Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
|
Flexibility assessed using Paris Plinth table with maximum extension of 20 degrees movement (as if performing a sit-up).
When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain.
Movement decreased 5 degrees (minus) and discomfort rated on VAS.
Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS.
Higher score indicated greater discomfort/pain.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
|
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Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
|
Flexibility assessed using Paris Plinth table with maximum side-to-side movement of +/- 10 degrees for L, R movement.
When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain.
Movement decreased 5 degrees (minus) and discomfort rated on VAS.
Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS.
Analyses based on the average of L, R scores.
Higher score indicated greater discomfort/pain.
|
Baseline (time of wrap application or oral treatment administration) and 4 hours
|
|
Change From Baseline in Pain Measurement for Flexibility Measure: Rotation
時間枠：Baseline (time of wrap application or oral treatment administration) and 4 hours
|
Flexibility assessed using Paris Plinth table with maximum rotation at waist of +/- 30 degrees for L, R movement.
When participant feels discomfort or pain, participant places a mark to rate discomfort/pain (maximum) on a VAS of 100 mm in length with 0=no discomfort/no pain up to 100=most discomfort/most pain.
Movement decreased 5 degrees (minus) and discomfort rated on VAS.
Movement increased 5 degrees (plus) beyond first point when pain was reported and discomfort/pain again rated on the VAS.
Analyses based on the average of L, R scores.
Higher score indicated greater discomfort/pain.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
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Number of Participants Per Categorical Score for Global Assessment of Study Treatment
時間枠：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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At hour 8, or at the time of rescue, if it occurred, participants performed a global assessment in their diary in response to the question: How would you rate the study treatment as a pain reliever?
Very Poor=0, Poor=1, Fair=2, Good=3, Very Good=4, Excellent=5.
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Baseline (time of wrap application or oral treatment administration) up to 8 hours
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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。
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。
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
2010年2月1日
一次修了 (実際)
2010年7月1日
研究の完了 (実際)
2010年7月1日
試験登録日
最初に提出
2010年1月8日
QC基準を満たした最初の提出物
2010年1月8日
最初の投稿 (見積もり)
2010年1月11日
学習記録の更新
投稿された最後の更新 (見積もり)
2013年4月1日
QC基準を満たした最後の更新が送信されました
2013年2月21日
最終確認日
2013年2月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- TC-09-20
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。
痛みの臨床試験
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Bingol UniversityAtaturk Universityまだ募集していません術前不安 | 恐れ | PAİN
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Dexa Medica Group完了
Heat Deviceの臨床試験
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Boston Medical CenterEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)完了
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Ohio State UniversityMedical University of South Carolina; Northwestern University終了しました
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University of RochesterNational Cancer Institute (NCI)まだ募集していません
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The University of Texas Health Science Center at...Congressionally Directed Medical Research Programs募集
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University of Kansas Medical Center招待による登録