Trial Outcomes & Findings for Imaging Study of Chronic Low Back Pain in Patients Taking Pain Medication (NCT NCT00388414)

Last Updated: 2017-12-11

Results Overview

Brief Pain Inventory (BPI) scores were obtained at baseline, weeks 1, 2, 6, 7, 8, and 12, and a follow-up visit one week after completing the study. Responses are rated on a scale from 0-10, with 0 = no pain and 10 = pain as bad as you can imagine. Placebo and duloxetine pain scores calculated by averaging pain scores from each visit after baseline. Values were converted to percent change in pain: \[(baseline pain - end point pain)/baseline pain\] x 100.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

3 months

Results posted on

2017-12-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.
First Intervention (8 Weeks) STARTED	7	7
First Intervention (8 Weeks) COMPLETED	7	7
First Intervention (8 Weeks) NOT COMPLETED	0	0
Washout (1 Week) STARTED	7	7
Washout (1 Week) COMPLETED	7	7
Washout (1 Week) NOT COMPLETED	0	0
Second Intervention (8 Weeks) STARTED	7	7
Second Intervention (8 Weeks) COMPLETED	7	7
Second Intervention (8 Weeks) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Then Duloxetine n=7 Participants 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 n=7 Participants 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 n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	31 years STANDARD_DEVIATION 11.36 • n=5 Participants	42.86 years STANDARD_DEVIATION 12.56 • n=7 Participants	36.93 years STANDARD_DEVIATION 13.05 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Placebo - Sugar Pill n=14 Participants Placebo: Placebo pill once daily	Duloxetine n=14 Participants duloxetine: 30-60mg of duloxetine daily	Duloxetine duloxetine: 30-60mg of duloxetine daily
Pain	-1 Percentage change from baseline to end Standard Deviation 76	-43 Percentage change from baseline to end Standard Deviation 32	—

PRIMARY outcome

Timeframe: 3 months

Scores reflect the average connectivity strength of that region of interest to the rest of the cortex. There were no minimum or maximum values on this scale. Higher scores reflect stronger connectivity, and lower scores reflect less connectivity (all scores fell within -3 and 3). Subscales are averaged.

Outcome measures

Outcome measures
Measure	Placebo - Sugar Pill n=14 Participants Placebo: Placebo pill once daily	Duloxetine n=14 Participants duloxetine: 30-60mg of duloxetine daily	Duloxetine n=14 Participants duloxetine: 30-60mg of duloxetine daily
Neural Correlates of Pain Relief Dorsal Default Mode Networks	0.485 Units on a scale Standard Deviation 0.277	0.492 Units on a scale Standard Deviation 0.203	0.469 Units on a scale Standard Deviation 0.315
Neural Correlates of Pain Relief Ventral Default Mode Networks	0.521 Units on a scale Standard Deviation 0.346	0.466 Units on a scale Standard Deviation 0.279	0.468 Units on a scale Standard Deviation 0.443

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab

Stanford University

Phone: (650) 498-6477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place