Back to resultsTrue Functional Restoration and Analgesia in Non-Radicular Low Back Pain (Covidien)
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Hydromorphone ER
Sugar pill
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Back Pain, Chronic back pain
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.
Sites / Locations
- Rehabilitation Institute of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar pill
Hydromorphone ER
Arm Description
Subjects may receive a pill with no medicine.
Subjects received study drug: Hydromorphone ER
Outcomes
Primary Outcome Measures
Change in McGill Pain Questionnaire - Short Form
The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
Change in VAS
Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).
Secondary Outcome Measures
Change in PASS
Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
Change in Pain Disability
The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most Disability.
Change in Stair Climb Time
Time to climb 1 flight of stairs
Change in Treadmill Distance Walked
Treadmill distance walked in 6 minutes
Change in Sit to Stand Repetitions
Sit to stand repetitions completed in 1 minute
Change in Distance to Floor
Distance from fingers to Floor when bending forward. A functional test of flexibility
Change in Time to Lift Box
Time to lift 13 pound box to floor and back up to table.
Change in NRS After Stair Climb
Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).
Change in NRS After Treadmill Walk
Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).
Change in NRS After Sit to Stand Repetitions
Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).
Change in NRS After Box Lift
Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).
Full Information
NCT ID
NCT01455519
First Posted
October 11, 2011
Last Updated
October 18, 2017
Sponsor
Shirley Ryan AbilityLab
Collaborators
Mallinckrodt
1. Study Identification
Unique Protocol Identification Number
NCT01455519
Brief Title
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
Acronym
Covidien
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
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shirley Ryan AbilityLab
Collaborators
Mallinckrodt
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Back Pain, Chronic back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Subjects may receive a pill with no medicine.
Arm Title
Hydromorphone ER
Arm Type
Active Comparator
Arm Description
Subjects received study drug: Hydromorphone ER
Intervention Type
Drug
Intervention Name(s)
Hydromorphone ER
Other Intervention Name(s)
Exalgo(hydromorphone HCl), CII (77605306)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Sugar pill
Intervention Description
Sugar pill
Primary Outcome Measure Information:
Title
Change in McGill Pain Questionnaire - Short Form
Description
The McGill Pain Questionnaire - Short Form (MPQ-SF) is a well-validated pain measure that permits separation of the sensory and affective components of pain, which are added together to compute a total score. The scale ranges from 0-45 (0=no pain, 45=the most pain).
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in VAS
Description
Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Secondary Outcome Measure Information:
Title
Change in PASS
Description
Anxiety scores were collected at least two data points. The Pain Anxiety Symptoms Scale (PASS) is a scale from 0 - 100, where 0 = no anxiety and 100 = the most anxiety.
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in Pain Disability
Description
The Pain Disability Index (PDI) is a seven-item, validated instrument that assesses perceived disability in seven key life areas. It provides a total disability score, and is an indirect measure of self efficacy. The Pain Disability Scale is a scale from 0 - 70, where 0 = no Disability and 70 = the most 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
Title
Change in Stair Climb Time
Description
Time to climb 1 flight of stairs
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in Treadmill Distance Walked
Description
Treadmill distance walked in 6 minutes
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in Sit to Stand Repetitions
Description
Sit to stand repetitions completed in 1 minute
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in Distance to Floor
Description
Distance from fingers to Floor when bending forward. A functional test of flexibility
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in Time to Lift Box
Description
Time to lift 13 pound box to floor and back up to table.
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in NRS After Stair Climb
Description
Numeric Rating Scale (NRS) pain score was given verbally after completing functional stair climb test on a scale 0-10 (0=none, and 10=the worst).
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in NRS After Treadmill Walk
Description
Numeric Rating Scale (NRS) pain score was given verbally after completing functional treadmill walk test on a scale 0-10 (0=none, and 10=the worst).
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in NRS After Sit to Stand Repetitions
Description
Numeric Rating Scale (NRS) pain score was given verbally after completing functional sit to stand test on a scale 0-10 (0=none, and 10=the worst).
Time Frame
Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Title
Change in NRS After Box Lift
Description
Numeric Rating Scale (NRS) pain score was given verbally after completing functional box lift test on a scale 0-10 (0=none, and 10=the worst).
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. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman Harden, M.D.
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Institute of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
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