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True Functional Restoration and Analgesia in Non-Radicular Low Back Pain (Covidien)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455519
First Posted: October 20, 2011
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Shirley Ryan AbilityLab
Results First Submitted: May 26, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: Hydromorphone ER
Drug: Sugar pill

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
51 subjects were enrolled at baseline. 13 withdrew from the study after visit 1, and 3 no longer met criteria at visit 2.

Reporting Groups
  Description
Sugar Pill Subjects may receive a pill with no medicine.
Hydromorphone ER Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.

Participant Flow:   Overall Study
    Sugar Pill   Hydromorphone ER
STARTED   12   23 
COMPLETED   8   18 
NOT COMPLETED   4   5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Sugar Pill Subjects may receive a pill with no medicine.
Hydromorphone ER

Subjects received study drug: Hydromorphone ER

Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.

Total Total of all reporting groups

Baseline Measures
   Sugar Pill   Hydromorphone ER   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   23   35 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.8  (10.7)   46.6  (9.2)   47.7  (9.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  41.7%      12  52.2%      17  48.6% 
Male      7  58.3%      11  47.8%      18  51.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      2  16.7%      0   0.0%      2   5.7% 
Not Hispanic or Latino      10  83.3%      23 100.0%      33  94.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      8  66.7%      13  56.5%      21  60.0% 
White      1   8.3%      8  34.8%      9  25.7% 
More than one race      1   8.3%      0   0.0%      1   2.9% 
Unknown or Not Reported      2  16.7%      2   8.7%      4  11.4% 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 32.8  (10.4)   29.3  (8.4)   30.5  (9.1) 
Duration of Pain 
[Units: Years]
Mean (Standard Deviation)
 12.6  (12.3)   8.7  (7.8)   10.0  (9.3) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in McGill Pain Questionnaire – Short Form   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

2.  Primary:   Change in VAS   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

3.  Secondary:   Change in PASS   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

4.  Secondary:   Change in Pain Disability   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

5.  Secondary:   Change in Stair Climb Time   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

6.  Secondary:   Change in Treadmill Distance Walked   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

7.  Secondary:   Change in Sit to Stand Repetitions   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

8.  Secondary:   Change in Distance to Floor   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

9.  Secondary:   Change in Time to Lift Box   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

10.  Secondary:   Change in NRS After Stair Climb   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

11.  Secondary:   Change in NRS After Treadmill Walk   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

12.  Secondary:   Change in NRS After Sit to Stand Repetitions   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]

13.  Secondary:   Change in NRS After Box Lift   [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Center for Pain Studies
Organization: Rehabilitation Institute of Chicago
phone: 312.238.5654
e-mail: centerforpainstudies@ric.org



Responsible Party: Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT01455519     History of Changes
Other Study ID Numbers: RIC_Cov_2011
First Submitted: October 11, 2011
First Posted: October 20, 2011
Results First Submitted: May 26, 2015
Results First Posted: July 13, 2015
Last Update Posted: October 24, 2017