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

• Sponsor: Shirley Ryan AbilityLab (Other)
• Overall Status: Completed
• CT.gov ID: NCT01455519
• Collaborator: Mallinckrodt (Industry)
• Enrollment: 51
• Location: 1
• Arms: 2
• Duration (Months): 38
• Patients Per Site Per Month: 1.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Drug: Hydromorphone ER; Drug: Sugar pill	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: True Functional Restoration and Analgesia in Non-Radicular Low Back Pain: a Prospective Double Blind, Placebo-controlled Study of Hydromorphone ER
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Sugar pill Subjects may receive a pill with no medicine.	Drug: Sugar pill; Sugar pill
Active Comparator: Hydromorphone ER 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.; Other Names: Exalgo(hydromorphone HCl), CII (77605306)

Outcome Measures

Primary Outcome Measures

1. 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).

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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

4. 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

5. 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

6. 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

7. 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.

8. 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).

9. 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).

10. 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).

11. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rehabilitation Institute of Chicago	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Shirley Ryan AbilityLab
• Mallinckrodt

Investigators

• Principal Investigator: Norman Harden, M.D., Shirley Ryan AbilityLab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shirley Ryan AbilityLab
• ClinicalTrials.gov Identifier: NCT01455519
• Other Study ID Numbers: RIC_Cov_2011
• First Posted: Oct 20, 2011
• Last Update Posted: Oct 24, 2017
• Last Verified: Oct 1, 2017

• Keywords provided by Shirley Ryan AbilityLab: Low Back Pain; Back Pain; Chronic back pain
• Additional relevant MeSH terms: Back Pain; Low Back Pain; Hydromorphone

Study Results

Participant Flow

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

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Period Title: Overall Study
STARTED	12	23
COMPLETED	8	18
NOT COMPLETED	4	5

Baseline Characteristics

Arm/Group Title	Sugar Pill	Hydromorphone ER	Total
Arm/Group Description	Subjects may receive a pill with no medicine.	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.	Total of all reporting groups
Overall Participants	12	23	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.8 (10.7)	46.6 (9.2)	47.7 (9.7)
Sex: Female, Male (Count of Participants)
Female	5 41.7%	12 52.2%	17 48.6%
Male	7 58.3%	11 47.8%	18 51.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 16.7%	0 0%	2 5.7%
Not Hispanic or Latino	10 83.3%	23 100%	33 94.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	8 66.7%	13 56.5%	21 60%
White	1 8.3%	8 34.8%	9 25.7%
More than one race	1 8.3%	0 0%	1 2.9%
Unknown or Not Reported	2 16.7%	2 8.7%	4 11.4%
Body Mass Index (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	32.8 (10.4)	29.3 (8.4)	30.5 (9.1)
Duration of Pain (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	12.6 (12.3)	8.7 (7.8)	10.0 (9.3)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [units on a scale]	-0.73 (2.33)	-3.78 (1.7)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [units on a scale]	-10.57 (9.54)	-10.67 (6.91)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [units on a scale]	-7.14 (2.94)	-5.85 (2.21)

4. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [units on a scale]	-9.84 (4.56)	-9.25 (3.36)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [seconds]	1.28 (1.08)	-1.25 (0.8)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [miles]	0.02 (0.02)	0.02 (0.01)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [number of repetitions]	-1.07 (1.52)	.54 (1.14)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [centimeters]	-4.61 (3.03)	-4.02 (2.26)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [seconds per lift]	-1.45 (1.13)	-1.06 (0.8)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [NRS pain score]	0.04 (0.23)	-0.11 (0.17)

11. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [NRS pain score]	0.1 (0.44)	-0.51 (0.32)

12. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [NRS pain score]	-0.24 (0.34)	-0.57 (0.25)

13. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sugar Pill	Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.	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.
Measure Participants	8	18
Mean (Standard Error) [NRS pain score]	0.39 (0.58)	-0.43 (0.36)

Adverse Events

Arm/Group Title	Sugar Pill		Hydromorphone ER
Arm/Group Description	Subjects may receive a pill with no medicine.		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.
All Cause Mortality
	Sugar Pill		Hydromorphone ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Sugar Pill		Hydromorphone ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/23 (0%)
Other (Not Including Serious) Adverse Events
	Sugar Pill		Hydromorphone ER
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.7%)		15/23 (65.2%)
Ear and labyrinth disorders
ear infection	0/12 (0%)		1/23 (4.3%)
Gastrointestinal disorders
stomach pain	1/12 (8.3%)		0/23 (0%)
heartburn	0/12 (0%)		1/23 (4.3%)
General disorders
nausea	0/12 (0%)		6/23 (26.1%)
fatigue	0/12 (0%)		4/23 (17.4%)
drowsiness	1/12 (8.3%)		9/23 (39.1%)
vomiting	1/12 (8.3%)		2/23 (8.7%)
trouble sleeping	0/12 (0%)		1/23 (4.3%)
itchiness	2/12 (16.7%)		1/23 (4.3%)
dizziness	0/12 (0%)		1/23 (4.3%)
diarrhea	0/12 (0%)		1/23 (4.3%)
lack of appetite	0/12 (0%)		1/23 (4.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.