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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01455519

Acronym

Covidien

Enrollment

Registered

2011-10-20

Start date

2011-10-31

Completion date

2014-12-31

Last updated

2017-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

Low Back Pain, Back Pain, Chronic back pain

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.

Interventions

DRUGHydromorphone 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.

DRUGSugar pill

Sugar pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in McGill Pain Questionnaire - Short Form	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	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).

Secondary

Measure	Time frame	Description
Change in Stair Climb Time	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	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	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	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 PASS	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 NRS After Stair Climb	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	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	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	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).
Change in Time to Lift Box	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 Pain Disability	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.

Countries

United States

Participant flow

Pre-assignment details

51 subjects were enrolled at baseline. 13 withdrew from the study after visit 1, and 3 no longer met criteria at visit 2.

Participants by arm

Arm	Count
Sugar Pill Subjects may receive a pill with no medicine.	12
Hydromorphone ER Subjects received study drug: Hydromorphone ER 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.	23
Total	35

Baseline characteristics

Characteristic	Sugar Pill	Total	Hydromorphone ER
Age, Continuous	49.8 years STANDARD_DEVIATION 10.7	47.7 years STANDARD_DEVIATION 9.7	46.6 years STANDARD_DEVIATION 9.2
Body Mass Index	32.8 kg/m2 STANDARD_DEVIATION 10.4	30.5 kg/m2 STANDARD_DEVIATION 9.1	29.3 kg/m2 STANDARD_DEVIATION 8.4
Duration of Pain	12.6 years STANDARD_DEVIATION 12.3	10.0 years STANDARD_DEVIATION 9.3	8.7 years STANDARD_DEVIATION 7.8
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants	2 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants	33 Participants	23 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Black or African American	8 Participants	21 Participants	13 Participants
Race (NIH/OMB) More than one race	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) White	1 Participants	9 Participants	8 Participants
Sex: Female, Male Female	5 Participants	17 Participants	12 Participants
Sex: Female, Male Male	7 Participants	18 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	5 / 12	15 / 23
serious Total, serious adverse events	0 / 12	0 / 23

Outcome results

Primary

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).