Clinical trial NCT01455519: True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Official title: True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain
Keywords: Low Back Pain
Back Pain
Chronic back pain
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2011-10-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: You are asked to take part in this study because you have chronic, non-radicular low back pain. This study is done to investigate the pain relieving effects of the study drug Exalgo (Hydromorphone ER) for people who experience chronic non-radicular low back pain. The purpose of this research is to look at how the study drug can be used to benefit people who experience this type of pain. This is a phase IV study done to study the safety and effectiveness of the drug. At this point the drug has been approved by the Food and Drug Administration and has been studied in more than 2,000 pain patients in clinical trials, including individuals with low back pain. About 36 subjects will take part in this study.

Detailed description: As a participant in this study, you will be asked to come to the Rehabilitation Institute of Chicago (RIC), Center for Pain Studies (446 E Ontario St. Suite 1011, Chicago, IL 60611). Your part in this study will last for 8 weeks and will involve 3 visits to the Rehabilitation Institute of Chicago and anywhere from weekly phone calls to phone calls every other day.

If you are in this study, you will be placed in one of two study groups: one group will receive the study drug and one will receive a placebo. You will be assigned a study group by chance using a process similar to the flip of a coin. This process is called randomization. Neither you nor the study staff will select the group you will be in. A placebo looks like the study drug but is an inactive substance that has no medication. Researchers use a placebo to see if the study drug works better or is safer than not taking anything. You will have a 66% chance of getting the study drug. You will receive placebo at some point during the study but you will not know whether you are receiving placebo or study drug during the entire study. However, if you have a medical emergency, the investigators can get this information.

Eligibility criteria: Inclusion Criteria:

* Meets our criteria for Chronic Non-Radicular Back Pain (CNRBP): non-radiating (below buttocks), no frank weakness or atrophy, no sensory or reflex changes
* If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl).
* Able to read and speak English and provide informed consent; ages: 18-90.
* Able to understand and comply with all data collection methodology.
* Subjects may continue any non opioid, non acetaminophen stable drug regimen with no changes during the course of study and not use rescue medications 12 hours before testing.
* Subjects taking opioids must agree to detoxify for the protocol. If they agree they will detox under the direction of the PI before entering the protocol. They may begin the acetaminophen rescue med as per the protocol while in detox.
* Must have pain greater than or equal to 5 on a 10 point Numeric Rating scale (NRS) at phone screening, or pain greater than or equal to 50 on VAS at visit one.

Exclusion Criteria:

* Subjects with hypersensitivity to Opioids, Acetominophen or Exalgo.
* Subjects with severe or untreated psychiatric disturbance (e.g. mania, depression \[esp suicidality\], anxiety, substance dependence).
* Subjects with a clinical diagnosis of fibromyalgia or polymyalgia rheumatica.
* Subjects with severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension), pulmonary disease, uncontrolled seizure disorder, gastoparesis or urinary retention.

Primary outcomes:
measure: Change in McGill Pain Questionnaire - Short Form
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in VAS
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Secondary outcomes:
measure: Change in PASS
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Pain Disability
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Stair Climb Time
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Treadmill Distance Walked
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Sit to Stand Repetitions
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Distance to Floor
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in Time to Lift Box
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in NRS After Stair Climb
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in NRS After Treadmill Walk
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in NRS After Sit to Stand Repetitions
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
measure: Change in NRS After Box Lift
timeFrame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Norman Harden, M.D.
role: PRINCIPAL_INVESTIGATOR
References: