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A Study To Evaluate Methods To Evaluate Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT01045993
First received: January 8, 2010
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
Results First Received: December 5, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Device: Heat Device
Device: Sham Device
Drug: marketed analgesic
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited who had primary muscular low back pain (in the Investigator’s best judgment), which was atraumatic (no traumatic injury within 48 hours of enrollment) and not caused by, or related to, any clinically significant, medical diseases, whose onset had occurred within the past 3 months.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants with at least moderate pain intensity on a 6-point categorical scale were randomized (N=61) to primary efficacy (heatwrap or oral placebo) or blinding groups (“sham” wrap or oral Ibuprofen). May have received rescue medication (oral acetaminophen) during the 4-hour evaluation period or at discharge after assessments completed.

Reporting Groups
  Description
ThermaCare® Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
Sham Wrap (Inactive) Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
Oral Ibuprofen (IBU) IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
Oral Placebo Oral Placebo matching Oral IBU.

Participant Flow:   Overall Study
    ThermaCare®     Sham Wrap (Inactive)     Oral Ibuprofen (IBU)     Oral Placebo  
STARTED     26     5     5     25  
COMPLETED     26     4     5     25  
NOT COMPLETED     0     1     0     0  
Treated-later found eligibility not met                 0                 1                 0                 0  



  Baseline Characteristics
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Reporting Groups
  Description
ThermaCare® Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
Sham Wrap (Inactive) Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
Oral Ibuprofen (IBU) IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
Oral Placebo Oral Placebo matching Oral IBU.
Total Total of all reporting groups

Baseline Measures
    ThermaCare®     Sham Wrap (Inactive)     Oral Ibuprofen (IBU)     Oral Placebo     Total  
Number of Participants  
[units: participants]
 		  26     5     5     25     61  
Age  
[units: years]
Mean ± Standard Deviation 		  30.0  ± 6.0     25.6  ± 5.4     30.0  ± 7.2     28.8  ± 7.7     29.1  ± 6.8  
Gender  
[units: participants]
 		         
Female     11     1     2     15     29  
Male     15     4     3     10     32  
Number of participants with categorical score for pain intensity [1]
[units: participants]
 		         
None=0     0     0     0     0     0  
Mild=1     0     0     0     0     0  
Moderate=2     19     3     2     20     44  
Moderately severe=3     7     1     3     4     15  
Severe=4     0     1     0     1     2  
Extreme=5     0     0     0     0     0  
Back Stiffness Score [2]
[units: millimeters]
Mean ± Standard Deviation 		  45.85  ± 13.18     55.00  ± 18.71     50.00  ± 10.61     51.24  ± 20.32     49.15  ± 16.67  
Flexibility Assessment: Extension (Angle) [3]
[units: degree of angle]
Mean ± Standard Deviation 		         
Maximum degrees     15.31  ± 4.53     16.48  ± 4.82     16.80  ± 3.89     14.07  ± 4.51     15.02  ± 4.48  
Minus 5 degrees     10.19  ± 4.38     11.26  ± 5.04     11.62  ± 3.70     9.01  ± 4.28     9.91  ± 4.32  
Plus 5 degrees (beyond maximum)     17.28  ± 4.48     18.50  ± 2.24     18.78  ± 4.35     17.59  ± 4.02     17.63  ± 4.08  
Flexibility Assessment: Extension (visual analog scale ([VAS]) [4]
[units: millimeters]
Mean ± Standard Deviation 		         
VAS at Maximum degrees     48.65  ± 15.69     41.00  ± 21.21     48.20  ± 13.52     43.40  ± 23.35     45.84  ± 19.26  
VAS at Minus 5 degrees     33.54  ± 19.41     26.60  ± 22.00     34.00  ± 11.51     29.36  ± 22.37     31.30  ± 20.11  
VAS at Plus 5 degrees (beyond maximum)     56.92  ± 20.27     50.00  ± 32.64     59.40  ± 14.28     52.60  ± 27.47     54.79  ± 23.78  
Flexibility Assessment: Side-to-Side (Angle) [5]
[units: degree of angle]
Mean ± Standard Deviation 		         
L Maximum degrees     6.92  ± 1.69     7.20  ± 1.79     6.50  ± 2.40     7.16  ± 1.50     7.01  ± 1.65  
R Maximum degrees     6.80  ± 1.76     7.40  ± 1.34     6.50  ± 2.06     6.76  ± 1.80     6.81  ± 1.74  
L Minus 5 degrees     2.15  ± 1.19     2.40  ± 1.34     2.00  ± 1.41     2.32  ± 1.07     2.23  ± 1.15  
R Minus 5 degrees     2.05  ± 1.27     2.40  ± 1.34     1.80  ± 1.64     1.92  ± 1.19     2.00  ± 1.25  
L Plus 5 degrees (beyond maximum)     7.22  ± 1.66     7.40  ± 1.34     6.60  ± 2.19     7.42  ± 1.40     7.26  ± 1.56  
R Plus 5 degrees (beyond maximum)     7.33  ± 1.41     7.70  ± 0.67     7.00  ± 1.39     7.02  ± 1.68     7.20  ± 1.47  
Flexibility Assessment: Side-to-side (VAS) [6]
[units: millimeters]
Mean ± Standard Deviation 		         
L VAS at Maximum degrees     42.69  ± 22.61     32.40  ± 14.64     43.60  ± 21.28     35.24  ± 25.87     38.87  ± 23.29  
R VAS at Maximum degrees     47.38  ± 25.18     40.40  ± 20.97     52.20  ± 14.45     45.40  ± 20.69     46.39  ± 22.03  
L VAS at Minus 5 degrees     24.85  ± 22.82     15.20  ± 9.47     28.20  ± 14.46     22.80  ± 18.77     23.49  ± 19.66  
R VAS at Minus 5 degrees     24.35  ± 19.57     19.80  ± 13.92     34.00  ± 19.96     24.96  ± 18.75     25.02  ± 18.68  
L VAS at Plus 5 degrees (beyond maximum)     40.58  ± 26.10     27.80  ± 15.42     48.20  ± 22.83     37.64  ± 25.93     38.95  ± 24.95  
R VAS at Plus 5 degrees (beyond maximum)     48.42  ± 26.16     42.40  ± 22.03     55.60  ± 13.63     44.92  ± 21.85     47.08  ± 23.05  
Flexibility Assessment: Rotation (Angle) [7]
[units: degree of angle]
Mean ± Standard Deviation 		         
L Maximum degrees     15.67  ± 4.08     17.36  ± 3.77     15.96  ± 6.44     17.03  ± 4.40     16.39  ± 4.35  
R Maximum degrees     16.78  ± 4.73     16.66  ± 4.26     16.62  ± 6.19     16.91  ± 4.78     16.81  ± 4.71  
L Minus 5 degrees     10.21  ± 4.12     11.30  ± 4.09     10.42  ± 6.19     11.46  ± 4.33     10.83  ± 4.31  
R Minus 5 degrees     11.27  ± 4.48     11.28  ± 4.38     10.74  ± 6.12     11.56  ± 4.46     11.34  ± 4.49  
L Plus 5 degrees (beyond maximum)     17.95  ± 3.28     17.66  ± 3.73     17.12  ± 5.13     18.24  ± 4.12     17.98  ± 3.75  
R Plus 5 degrees (beyond maximum)     18.48  ± 4.14     18.46  ± 3.73     18.06  ± 4.39     18.32  ± 4.30     18.38  ± 4.10  
Flexibility Assessment: Rotation (VAS) [8]
[units: millimeters]
Mean ± Standard Deviation 		         
L VAS at Maximum degrees     52.54  ± 23.88     60.00  ± 23.74     60.60  ± 12.30     48.80  ± 23.41     52.28  ± 22.81  
R VAS at Maximum degrees     51.65  ± 21.33     59.40  ± 31.09     61.60  ± 15.84     49.64  ± 25.97     52.28  ± 23.56  
L VAS at Minus 5 degrees     36.92  ± 21.25     47.20  ± 22.94     46.60  ± 21.24     33.24  ± 22.28     37.05  ± 21.77  
R VAS at Minus 5 degrees     38.15  ± 22.26     44.20  ± 27.47     47.40  ± 15.84     36.56  ± 25.02     38.75  ± 23.12  
L VAS at Plus 5 degrees (beyond maximum)     56.62  ± 25.62     63.80  ± 18.79     65.80  ± 12.19     49.24  ± 22.12     54.93  ± 23.10  
R VAS at Plus 5 degrees (beyond maximum)     59.12  ± 27.10     66.40  ± 28.17     64.20  ± 11.50     50.92  ± 26.61     56.77  ± 26.08  
[1] Participant rated the severity of their pain on a 6-point scale in response to the question "How much pain are you experiencing in your lower back right now". Scored as None=0, Mild=1, Moderate=2, Moderately severe=3, Severe=4, Extreme=5. Participant was asked to remember the level of pain experienced at this time as a reference for any pain relief experienced at later time points.
[2] Participant rated their low back muscle stiffness by placing a line on a visual analog scale (VAS) in response to the question “Please indicate a number from 0 through 100 that best describes your low back muscle stiffness”. VAS scaled as 0 millimeters (mm) to 100 mm in length with 0 (no muscle stiffness) up to 100 (most possible stiffness).
[3] Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility.
[4] Flexibility assessed using Paris Plinth table with maximum extension (as if performing a sit-up) of 20 degrees movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain 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 and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain.
[5] Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus 10 degrees for left (L), and right (R), movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility.
[6] Flexibility assessed using Paris Plinth table with maximum side-to-side movement of plus or minus 10 degrees for left, and right, movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain 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 and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain.
[7] Flexibility assessed using Paris Plinth table with maximum rotation at waist movement of plus or minus 30 degrees for left, and right, movement. Angle at baseline standardized to 100 for assessment of maximum angle (x degrees) up to the degree of movement at which participant perceives discomfort or pain, x degrees minus 5, and x degrees plus 5. Greater degree of angle indicated greater flexibility.
[8] Flexibility assessed using Paris Plinth table with maximum rotation at waist of plus or minus 30 degrees for left, and right, movement. When participant feels discomfort or pain, participant places a mark to rate discomfort/pain 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 and discomfort rated on VAS. Movement increased 5 degrees beyond first point when pain was reported and discomfort/pain again rated on the VAS. Higher scores indicated greater pain.



  Outcome Measures
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1.  Primary:   Time to First Perceptible Relief (Confirmed by Meaningful Relief)   [ Time Frame: Baseline (time of wrap application or oral treatment administration) up to 4 hours ]
  Show Outcome Measure 1

2.  Secondary:   Time to Meaningful Relief   [ Time Frame: Baseline (time of wrap application or oral treatment administration) up to 4 hours ]
  Show Outcome Measure 2

3.  Secondary:   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 ]
  Show Outcome Measure 3

4.  Secondary:   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 ]
  Show Outcome Measure 4

5.  Secondary:   Time to Treatment Failure   [ Time Frame: Baseline (time of wrap application or oral treatment administration) up to 8 hours ]
  Show Outcome Measure 5

6.  Secondary:   Individual Time-Point Pain Relief Scores   [ Time Frame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Individual Time-point Back Stiffness Scores   [ Time Frame: At 60, 120, 180, 240, 300, 360, 420, and 480 minutes ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline (Bsl) in Combined Flexibility Score: Extension   [ Time Frame: Baseline (time of wrap application or oral treatment administration) and 4 hours ]
  Show Outcome Measure 8

9.  Secondary:   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 ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline (Bsl) in Overall Combined Flexibility Score: Rotation   [ Time Frame: Baseline (time of wrap application or oral treatment administration) and 4 hours ]
  Show Outcome Measure 10

11.  Secondary:   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 ]
  Show Outcome Measure 11

12.  Secondary:   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 ]
  Show Outcome Measure 12

13.  Secondary:   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 ]
  Show Outcome Measure 13

14.  Secondary:   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 ]
  Show Outcome Measure 14

15.  Secondary:   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 ]
  Show Outcome Measure 15

16.  Secondary:   Change From Baseline in Pain Measurement for Flexibility Measure: Rotation   [ Time Frame: Baseline (time of wrap application or oral treatment administration) and 4 hours ]
  Show Outcome Measure 16

17.  Secondary:   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 ]
  Show Outcome Measure 17


  Serious Adverse Events
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  Other Adverse Events
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No primary endpoint was prespecified in this Pilot study; 1 key efficacy endpoint was selected for reporting purposes only.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


No publications provided


Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT01045993     History of Changes
Other Study ID Numbers: TC-09-20
Study First Received: January 8, 2010
Results First Received: December 5, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board