A Phase 4 interventional study of Hydromorphone ER and Sugar pill in Low Back Pain, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-24.
Sponsored by Shirley Ryan AbilityLab · Phase 4, Interventional, and Treatment
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.
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's enrollment of 51 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects may receive a pill with no medicine.
Drug: Sugar pill
Subjects received study drug: Hydromorphone ER
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.
Also known as: Exalgo(hydromorphone HCl), CII (77605306)
Sugar pill
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).
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Change in VAS
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
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.
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
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.
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
Change in Stair Climb Time
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
Change in Treadmill Distance Walked
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
Change in Sit to Stand Repetitions
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
Change in Distance to Floor
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
Change in Time to Lift Box
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
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).
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
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).
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
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).
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
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).
Time frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention
| Milestone | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Started | 12 | 23 |
| Completed | 8 | 18 |
| Not completed | 4 | 5 |
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).
| units on a scale | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in McGill Pain Questionnaire - Short Form | -0.73 ± 2.33 | -3.78 ± 1.7 |
Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).
| units on a scale | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in VAS | -10.57 ± 9.54 | -10.67 ± 6.91 |
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.
| units on a scale | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in PASS | -7.14 ± 2.94 | -5.85 ± 2.21 |
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.
| units on a scale | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Pain Disability | -9.84 ± 4.56 | -9.25 ± 3.36 |
Time to climb 1 flight of stairs
| seconds | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Stair Climb Time | 1.28 ± 1.08 | -1.25 ± 0.8 |
Treadmill distance walked in 6 minutes
| miles | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Treadmill Distance Walked | 0.02 ± 0.02 | 0.02 ± 0.01 |
Sit to stand repetitions completed in 1 minute
| number of repetitions | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Sit to Stand Repetitions | -1.07 ± 1.52 | .54 ± 1.14 |
Distance from fingers to Floor when bending forward. A functional test of flexibility
| centimeters | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Distance to Floor | -4.61 ± 3.03 | -4.02 ± 2.26 |
Time to lift 13 pound box to floor and back up to table.
| seconds per lift | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in Time to Lift Box | -1.45 ± 1.13 | -1.06 ± 0.8 |
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).
| NRS pain score | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in NRS After Stair Climb | 0.04 ± 0.23 | -0.11 ± 0.17 |
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).
| NRS pain score | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in NRS After Treadmill Walk | 0.1 ± 0.44 | -0.51 ± 0.32 |
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).
| NRS pain score | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in NRS After Sit to Stand Repetitions | -0.24 ± 0.34 | -0.57 ± 0.25 |
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).
| NRS pain score | Sugar Pill | Hydromorphone ER |
|---|---|---|
| Change in NRS After Box Lift | 0.39 ± 0.58 | -0.43 ± 0.36 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sugar Pill | — | 0/12 (0%) | 5/12 (41.7%) |
| Hydromorphone ER | — | 0/23 (0%) | 15/23 (65.2%) |
| Event | Sugar Pill | Hydromorphone ER |
|---|---|---|
| drowsinessGeneral disorders | 1/12 | 9/23 |
| nauseaGeneral disorders | 0/12 | 6/23 |
| fatigueGeneral disorders | 0/12 | 4/23 |
| itchinessGeneral disorders | 2/12 | 1/23 |
| vomitingGeneral disorders | 1/12 | 2/23 |
| stomach painGastrointestinal disorders | 1/12 | 0/23 |
| trouble sleepingGeneral disorders | 0/12 | 1/23 |
| dizzinessGeneral disorders | 0/12 | 1/23 |
| diarrheaGeneral disorders | 0/12 | 1/23 |
| ear infectionEar and labyrinth disorders | 0/12 | 1/23 |
| Age, Continuous(years) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| Mean | 49.8 ± 10.7 | 46.6 ± 9.2 | 47.7 ± 9.7 |
| Sex: Female, Male(Participants) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| Female | 5 | 12 | 17 |
| Male | 7 | 11 | 18 |
| Ethnicity (NIH/OMB)(Participants) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 2 |
| Not Hispanic or Latino | 10 | 23 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 8 | 13 | 21 |
| White | 1 | 8 | 9 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 2 | 2 | 4 |
| Body Mass Index(kg/m2) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| Mean | 32.8 ± 10.4 | 29.3 ± 8.4 | 30.5 ± 9.1 |
| Duration of Pain(years) | Sugar Pill | Hydromorphone ER | Total |
|---|---|---|---|
| Mean | 12.6 ± 12.3 | 8.7 ± 7.8 | 10.0 ± 9.3 |
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Shirley Ryan AbilityLab