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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01455519
First Posted: October 20, 2011
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Shirley Ryan AbilityLab
October 11, 2011
October 20, 2011
May 26, 2015
July 13, 2015
October 24, 2017
October 2011
December 2014   (Final data collection date for primary outcome measure)
  • Change in McGill Pain Questionnaire - Short Form [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Visual Analogue Scale is a self report pain scale on a scale 0(no pain) to 100 (the worst pain imaginable).
The efficacy of Exalgo (hydromorphone HCl extended release) in Chronic Non-Radicular Low Back Pain (CNRBP) model syndrome to improve pain, function and activity [ Time Frame: Three visits over eight week period ]
Intent to treat analyses will compare data from the groups for all participants with at least two data points. A series of mixed design ANOVAs will be completed with data from objective functional testing, quasi-objective functional and psychophysical testing, subject pain questionnaires and subjective perceived function and quality of life.
Complete list of historical versions of study NCT01455519 on ClinicalTrials.gov Archive Site
  • Change in PASS [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Time to climb 1 flight of stairs
  • Change in Treadmill Distance Walked [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Treadmill distance walked in 6 minutes
  • Change in Sit to Stand Repetitions [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Sit to stand repetitions completed in 1 minute
  • Change in Distance to Floor [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Distance from fingers to Floor when bending forward. A functional test of flexibility
  • Change in Time to Lift Box [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    Time to lift 13 pound box to floor and back up to table.
  • Change in NRS After Stair Climb [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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 [ Time Frame: Collected at 2 visits over 8-10 weeks: Visit 1 and Visit 4. Change values were calculated from Baseline to post intervention ]
    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).
The relationship between pain ratings and functioning [ Time Frame: Three visits over an eight week period ]
A second set of follow-up analyses will test for nonlinear patterns of change over time. It is expected that some outcome factors will show quadratic trends such that, for instance, activity level will change depending on pain ratings.
Not Provided
Not Provided
 
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain
True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Low Back Pain
  • 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.
    Other Name: Exalgo(hydromorphone HCl), CII (77605306)
  • Drug: Sugar pill
    Sugar pill
  • Placebo Comparator: Sugar pill
    Subjects may receive a pill with no medicine.
    Intervention: Drug: Sugar pill
  • Active Comparator: Hydromorphone ER
    Subjects received study drug: Hydromorphone ER
    Intervention: Drug: Hydromorphone ER
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01455519
RIC_Cov_2011
Yes
Not Provided
Not Provided
Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
Mallinckrodt
Principal Investigator: Norman Harden, M.D. Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP