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

PHASE4CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

October 31, 2011

Primary Completion Date

December 31, 2014

Study Completion Date

December 31, 2014

Conditions
Low Back Pain
Interventions
DRUG

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.

DRUG

Sugar pill

Sugar pill

Trial Locations (1)

60611

Rehabilitation Institute of Chicago, Chicago

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mallinckrodt

INDUSTRY

lead

Shirley Ryan AbilityLab

OTHER