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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.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

61

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Loma Linda、California、美国、92350
        • Pfizer Investigational Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 55年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器：1
Heat device
设备：Heat Device
8-Hour Heatwrap
其他名称：
  • Heatwrap
假比较器：2
Placebo arm
设备：Sham Device
Inactive wrap worn for 8 hours
有源比较器：3
Marketed analgesic
药品：marketed analgesic
2 x 200 mg ibuprofen tablets
安慰剂比较：4
(Oral) Placebo comparator
药品：Placebo
2 x placebo tablets

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Time to First Perceptible Relief (Confirmed by Meaningful Relief)
大体时间：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.
Baseline (time of wrap application or oral treatment administration) up to 4 hours

次要结果测量

结果测量
措施说明
大体时间
Time to Meaningful Relief
大体时间：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.
Baseline (time of wrap application or oral treatment administration) up to 4 hours
Time Weighted Sum of Pain Relief From 0 Through 8 Hours (TOTPAR 0-8)
大体时间：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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.
Baseline (time of wrap application or oral treatment administration) up to 8 hours
Time Weighted Sum of Change From Baseline in the Back Stiffness Score Over 8 Hours
大体时间：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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.
Baseline (time of wrap application or oral treatment administration) up to 8 hours
Time to Treatment Failure
大体时间：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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).
Baseline (time of wrap application or oral treatment administration) up to 8 hours
Individual Time-Point Pain Relief Scores
大体时间：At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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.
At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
Change From Baseline in Individual Time-point Back Stiffness Scores
大体时间：At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
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).
At 60, 120, 180, 240, 300, 360, 420, and 480 minutes
Change From Baseline (Bsl) in Combined Flexibility Score: Extension
大体时间：Baseline (time of wrap application or oral treatment administration) and 4 hours
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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline (Bsl) in Overall Combined Flexibility Score: Side-to-Side
大体时间：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 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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
大体时间：Baseline (time of wrap application or oral treatment administration) and 4 hours
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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Extension
大体时间：Baseline (time of wrap application or oral treatment administration) and 4 hours
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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Side-to-Side
大体时间：Baseline (time of wrap application or oral treatment administration) and 4 hours
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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline in the Angle Measurement at Maximum Flexion for Flexibility Measures: Rotation
大体时间：Baseline (time of wrap application or oral treatment administration) and 4 hours
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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline (Bsl) in Pain Measurement for Flexibility Measure: Extension
大体时间：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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
大体时间：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
大体时间：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.
Baseline (time of wrap application or oral treatment administration) and 4 hours
Number of Participants Per Categorical Score for Global Assessment of Study Treatment
大体时间：Baseline (time of wrap application or oral treatment administration) up to 8 hours
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.
Baseline (time of wrap application or oral treatment administration) up to 8 hours

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Wyeth is now a wholly owned subsidiary of Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年2月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2010年7月1日

研究注册日期

首次提交

2010年1月8日

首先提交符合 QC 标准的

2010年1月8日

首次发布 (估计)

2010年1月11日

研究记录更新

最后更新发布 (估计)

2013年4月1日

上次提交的符合 QC 标准的更新

2013年2月21日

最后验证

2013年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TC-09-20

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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