- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01045993
A Study To Evaluate Methods To Evaluate Back Pain
February 21, 2013 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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Loma Linda, California, United States, 92350
- Pfizer Investigational Site
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Heat device
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8-Hour Heatwrap
Other Names:
|
Sham Comparator: 2
Placebo arm
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Inactive wrap worn for 8 hours
|
Active Comparator: 3
Marketed analgesic
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2 x 200 mg ibuprofen tablets
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Placebo Comparator: 4
(Oral) Placebo comparator
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2 x placebo tablets
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to First Perceptible Relief (Confirmed by Meaningful Relief)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Meaningful Relief
Time Frame: 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)
Time Frame: 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.
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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
Time Frame: 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
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Time to Treatment Failure
Time Frame: 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).
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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
Time Frame: 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.
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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
Time Frame: 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
Time Frame: 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.
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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
Time Frame: 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.
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Baseline (time of wrap application or oral treatment administration) and 4 hours
|
Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation
Time Frame: 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.
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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
Time Frame: 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
Time Frame: 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.
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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
Time Frame: 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
Time Frame: 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
|
Change From Baseline in Pain Measurement for Flexibility Measure: Side-to-Side
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
January 8, 2010
First Submitted That Met QC Criteria
January 8, 2010
First Posted (Estimate)
January 11, 2010
Study Record Updates
Last Update Posted (Estimate)
April 1, 2013
Last Update Submitted That Met QC Criteria
February 21, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TC-09-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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