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Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication

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ClinicalTrials.gov Identifier: NCT00388414
Recruitment Status : Completed
First Posted : October 16, 2006
Results First Posted : December 11, 2017
Last Update Posted : December 11, 2017
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Low Back Pain
Interventions: Drug: duloxetine
Drug: Placebo

  Participant Flow

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
No text entered.

Reporting Groups
  Description
Placebo Then Duloxetine In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
Duloxetine Then Placebo In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.

Participant Flow for 3 periods

Period 1:   First Intervention (8 Weeks)
    Placebo Then Duloxetine   Duloxetine Then Placebo
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 

Period 2:   Washout (1 Week)
    Placebo Then Duloxetine   Duloxetine Then Placebo
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 

Period 3:   Second Intervention (8 Weeks)
    Placebo Then Duloxetine   Duloxetine Then Placebo
STARTED   7   7 
COMPLETED   7   7 
NOT COMPLETED   0   0 



  Baseline Characteristics

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
Placebo Then Duloxetine In the first 8-week treatment period, participants received placebo to match duloxetine for 8 weeks. Following a -week washout period, in the second 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week).
Duloxetine Then Placebo In the first 8-week treatment period, participants received duloxetine starting at 30 mg (1 week), with titer up to 60 mg (2 weeks), maintained dose (4 weeks), and titer back down to 30 mg (1 week). Following a -week washout period, in the second 8-week treatment period, participants received placebo to match duloxetine for 8 weeks.
Total Total of all reporting groups

Baseline Measures
   Placebo Then Duloxetine   Duloxetine Then Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   7   14 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      7 100.0%      7 100.0%      14 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 31  (11.36)   42.86  (12.56)   36.93  (13.05) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      7 100.0%      7 100.0%      14 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   7   7   14 


  Outcome Measures

1.  Primary:   Pain   [ Time Frame: 3 months ]

2.  Primary:   Neural Correlates of Pain Relief   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  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 text entered.


  More Information

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: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization: Stanford University
phone: (650) 498-6477
e-mail: smackey@stanford.edu



Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT00388414     History of Changes
Other Study ID Numbers: F1J-MC-I006
First Submitted: October 12, 2006
First Posted: October 16, 2006
Results First Submitted: April 22, 2017
Results First Posted: December 11, 2017
Last Update Posted: December 11, 2017