Lumbar Spinal Stenosis
Conditions
Brief summary
The primary objective of the proposed pilot study is to determine the efficacy of oxymorphone hydrochloride and propoxyphene/acetaminophen combination in prolonging the time to onset of pain and reducing the severity of pain associated with walking in patients lumbar spinal stenosis that have clinical symptoms of neurogenic claudication. Neurogenic claudication is defined as movement induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing. The secondary objective is to examine the functional benefit of oxymorphone hydrochloride and propoxyphene/acetaminophen combination with respect to improvement in duration and distance of walking.
Detailed description
A computer-generated randomization plan was used for assignment of subjects to one of six treatment sequences (4 subjects per sequence): oxymorphone/propoxyphene/placebo, oxymorphone/placebo/propoxyphene, placebo/oxymorphone/propoxyphene, placebo/propoxyphene/oxymorphone, propoxyphene/oxymorphone/placebo, or propoxyphene/placebo/oxymorphone. One dose of blinded study drug (opana, propoxypehen, or placebo) was given at study days 1, 5, and 9. The primary endpoint was time to first symptoms of moderate intensity (NRS ≥ 4/10) during treadmill ambulation. Ambulation assessment was performed during the screening visit. Ambulation assessment was also performed 90 minutes after administration of study drug on days 1, 5 and 9, to evaluate pain intensity associated with walking as well as distance covered by the patients. Quantitative assessment of ambulation was conducted on a treadmill at 0° ramp incline at 1.2 miles per hour (mph). Measurement of self-reported symptom severity using the NRS at baseline, and every 30 seconds for a maximum of 15 minutes was recorded. The following information was also recorded: time to first symptoms, total ambulation time. The examination was stopped after 15 minutes or at the onset of severe symptoms. Severe symptoms were defined as the level of discomfort that would make patients stop walking in usual life situations. No one was encouraged or prompted to continue walking beyond this point. Patients were instructed to walk with an upright posture. They were not permitted to lean forward or hold onto the handrails during the examination. Secondary outcome measures included area under the curve of present pain intensity with ambulation at each specified time point, final pain intensity with walking, walking tolerance, time to return to baseline pain level after ambulation, as well as the results of a series of pain related questionnaires including: Visual Analog Scale (VAS), Patient Global Assessment (PGA), NRS, Roland Morris Disability Questionnaire (RMDQ), modified Brief Pain Inventory short form (mBPI-sf), Oswestry Disability Index (ODI), and Swiss Spinal Stenosis (SSS).
Interventions
DRUGopana then darvocet then placebo
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
DRUGopana then placebo then darvocet
Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
DRUGplacebo then opana then darvocet
Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit.
DRUGPlacebo then darvocet then opana
Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
DRUGDarvocet then opana then placebo
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit.
DRUGDarvocet then placebo then opana
Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit.
Sponsors
Endo Pharmaceuticals
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must present with clinical symptoms of neurogenic claudication (exercise induced leg pain, numbness, heaviness, or vague discomfort in part or all of one or both legs provoked with walking and standing and relieved by sitting, squatting, or forward flexion posturing) and endorse limitation of walking tolerance due to these symptoms * Numeric Rating Scale (NRS) for pain ≥ 6 in response to the following question: Circle one number (from 0=no pain to 10=worst pain) - How would you rate the worst leg and lower back pain you experienced during walking last week? * Patients must have confirmatory imaging by MRI or CT scan demonstrating at least one level of lumbar spinal stenosis within 1 year * Duration of symptoms \> 3 months * Age \> 50 years; male or female
Exclusion criteria
* Past or present existence of a movement disorder, e.g., Parkinsonism, or an neurologic disease that might affect the ability to ambulate (e.g., signs/symptoms of cauda equina compression) * Cognitive impairment preventing full understanding or participation in the study * Peripheral vascular disease * Moderate to severe arthritis of the knee or hip that might severely compromise ambulation * Past or present lower extremity peripheral vascular disease * Serious concomitant medical illness (e.g., heart disease) that might impair ambulation assessment * Previous lumbar surgery for spinal stenosis (laminectomy with or without fusion) within the past 2 years or epidural steroid injection in the preceding 4 months. * Severe psychiatric disorder * Mean time to severe symptoms \> 15 minutes. * Epidural steroid treatment within the last three months * History of drug or alcohol dependence * Serious intercurrent illness * Hypersensitivity to oxymorphone hydrochloride * Hypersensitivity to propoxyphene or acetaminophen * Severe bronchial asthma or hypercarbia, morphine analogs such as codeine, or any of the other ingredients of Opana * Suspicion of paralytic ileus * Moderate or severe hepatic impairment * Major conduction abnormality on ECG or cardiac (Bruce protocol) stress test within the past year. * Ongoing treatment with a long-acting opioid or regularly-scheduled use of a short acting opioid (\>3 doses/day on four or more days/week).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Symptoms (Tfirst) of Moderate Pain | study visit | Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve | study visit | Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked. |
| Total Distance | study visit | Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill. |
| Recovery Time | study visit | After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes. |
| Visual Analog Scale (VAS) | study visit | The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain. |
| Patient Global Assessment (PGA) | study visit | Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor. |
| Swiss Spinal Stenosis Score- Physical Function | study visit | The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function. |
| Modified Brief Pain Inventory (mBPI)- Interference Score | study visit | The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities. |
| Oswestry Disability Index (ODI) Score | study visit | The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability. |
| Swiss Spinal Stenosis Score- Symptom Severity | study visit | The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity. |
| Final Pain | study visit | Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity. |
| Roland Morris Disability Questionnaire (RMDQ) | study visit | The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled). |
Countries
United States
Participant flow
Recruitment details
08 December 2007 (initial IRB approval) to 26 August 2011\* (final study results) First patient enrolled: 12 June 2008. Last patient completed: 12 October 2010 \*Study terminated on 29 November 2010 due to US Food and Drug Administration (FDA) removing active control (Darvocet) from the U.S. market.
Pre-assignment details
Forty-three subjects signed the Research Subject Review Board (local IRB) approved consent form. Nineteen subjects failed screening and did not meet inclusion criteria. Twenty-four subjects met radiographic and treadmill criteria for neurogenic claudication and were randomized. Of these, 21 subjects completed all phases of the study
Participants by arm
| Arm | Count |
|---|---|
| Opana Then Darvocet Then Placebo Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit. | 4 |
| Opana Then Placebo Then Darvocet Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit. | 4 |
| Placebo Then Opana Then Darvocet Placebo tablet tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) was given one time at the third study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the fourth study visit. | 4 |
| Placebo Then Darvocet Then Opana Placebo tablet tablet was given one time at the second study visit, four days later darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit. | 4 |
| Darvocet Then Opana Then Placebo Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the third study visit, four days later placebo tablet was given one time at the fourth study visit. | 4 |
| Darvocet Then Placebo Then Opana Darvocet (100mg Propoxyphene/650mg Acetaminophen) tablet was given one time at the second study visit, four days later placebo tablet was given one time at the third study visit, four days later Opana IR, 5mg (oxymorphone hydrochloride) tablet was given one time at the fourth study visit. | 4 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Opana Then Placebo Then Darvocet | Placebo Then Opana Then Darvocet | Placebo Then Darvocet Then Opana | Opana Then Darvocet Then Placebo | Darvocet Then Opana Then Placebo | Darvocet Then Placebo Then Opana | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 4 Participants | 4 Participants | 3 Participants | 2 Participants | 20 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants |
| Age, Continuous | 73.0 years STANDARD_DEVIATION 3.2 | 76.0 years STANDARD_DEVIATION 12 | 70.0 years STANDARD_DEVIATION 4.8 | 69.5 years STANDARD_DEVIATION 4 | 76.0 years STANDARD_DEVIATION 15.2 | 63.3 years STANDARD_DEVIATION 6.8 | 71.3 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 4 participants | 24 participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 3 Participants | 0 Participants | 3 Participants | 2 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 2 / 4 | 0 / 3 | 0 / 4 | 0 / 2 | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 3 | 0 / 4 | 0 / 2 | 0 / 4 |
Outcome results
Primary
Time to First Symptoms (Tfirst) of Moderate Pain
Using the Numeric Rating Scale (NRS) (0=no pain, 10=worst pain imaginable)the time to first symptoms (Tfirst) with a NRS score greater than or equal to 4 (moderate pain level), with treadmill ambulation was measured. Patients were excluded from the trial if there pain at rest was greater than or equal to 4/10.
Time frame: study visit
Population: The analyses included all 24 enrolled randomized subjects based on inclusion/exclusion criteria except for three who withdrew from trial prior to completion of study. One dropped out (physician decision) due to an adverse event (AE) (dizzy) and two dropped due to scheduling. This singular AE is not included in the AE reporting below.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Time to First Symptoms (Tfirst) of Moderate Pain | 1.73 minutes | Standard Deviation 1.68 |
| Opana Then Placebo Then Darvocet | Time to First Symptoms (Tfirst) of Moderate Pain | 3.02 minutes | Standard Deviation 2.9 |
| Placebo Then Opana Then Darvocet | Time to First Symptoms (Tfirst) of Moderate Pain | 3.93 minutes | Standard Deviation 3.22 |
| Placebo Then Darvocet Then Opana | Time to First Symptoms (Tfirst) of Moderate Pain | 2.65 minutes | Standard Deviation 3.23 |
| Darvocet Then Opana Then Placebo | Time to First Symptoms (Tfirst) of Moderate Pain | 0.83 minutes | Standard Deviation 0.73 |
| Darvocet Then Placebo Then Opana | Time to First Symptoms (Tfirst) of Moderate Pain | 5.43 minutes | Standard Deviation 4.28 |
Secondary
Area Under the Curve
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals (every 30 seconds) subjects were asked what their pain level was according to the NRS. The area under the curve of present pain intensity is the total area combined for the amount of time the subject walked.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Area Under the Curve | 76.0 units on a scale * minutes | Standard Deviation 39.5 |
| Opana Then Placebo Then Darvocet | Area Under the Curve | 95.7 units on a scale * minutes | Standard Deviation 27.7 |
| Placebo Then Opana Then Darvocet | Area Under the Curve | 95.0 units on a scale * minutes | Standard Deviation 35.9 |
| Placebo Then Darvocet Then Opana | Area Under the Curve | 86.4 units on a scale * minutes | Standard Deviation 39 |
| Darvocet Then Opana Then Placebo | Area Under the Curve | 123.3 units on a scale * minutes | Standard Deviation 6.3 |
| Darvocet Then Placebo Then Opana | Area Under the Curve | 79.6 units on a scale * minutes | Standard Deviation 31.5 |
Secondary
Final Pain
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. At defined intervals subjects were asked what their pain level was according to the NRS. When the subject reached their maximum distance, they were asked their NRS score. This was recorded as final pain intensity.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Final Pain | 4.6 units on a scale | Standard Deviation 2.2 |
| Opana Then Placebo Then Darvocet | Final Pain | 6.6 units on a scale | Standard Deviation 1.6 |
| Placebo Then Opana Then Darvocet | Final Pain | 6.2 units on a scale | Standard Deviation 2.7 |
| Placebo Then Darvocet Then Opana | Final Pain | 6.7 units on a scale | Standard Deviation 2.5 |
| Darvocet Then Opana Then Placebo | Final Pain | 8.0 units on a scale | Standard Deviation 0.6 |
| Darvocet Then Placebo Then Opana | Final Pain | 7.1 units on a scale | Standard Deviation 1.9 |
Secondary
Modified Brief Pain Inventory (mBPI)- Interference Score
The mBPI is a series of questions that rates the severity and impact of pain on daily function. The questionnaire is made up of 4 pain severity items using the NRS scale, and seven 11-point pain interference scales (0 indicating no interference and 10 indicating complete interference). For the interference score, a total score of 10 indicates pain completely interferes with activities.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Modified Brief Pain Inventory (mBPI)- Interference Score | 3.7 units on a scale | Standard Deviation 2 |
| Opana Then Placebo Then Darvocet | Modified Brief Pain Inventory (mBPI)- Interference Score | 4.2 units on a scale | Standard Deviation 1.4 |
| Placebo Then Opana Then Darvocet | Modified Brief Pain Inventory (mBPI)- Interference Score | 2.7 units on a scale | Standard Deviation 0.8 |
| Placebo Then Darvocet Then Opana | Modified Brief Pain Inventory (mBPI)- Interference Score | 4.3 units on a scale | Standard Deviation 1.3 |
| Darvocet Then Opana Then Placebo | Modified Brief Pain Inventory (mBPI)- Interference Score | 6.2 units on a scale | Standard Deviation 1 |
| Darvocet Then Placebo Then Opana | Modified Brief Pain Inventory (mBPI)- Interference Score | 2.8 units on a scale | Standard Deviation 2.6 |
Secondary
Oswestry Disability Index (ODI) Score
The ODI is a set of 10 questions each with five choices (maximum score of 5 points per question) designed to determine how back pain has affected the ability to manage everyday life (pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and change positions). A score of 0 indicates no disability and total score of 50 would indicate 100% disability.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Oswestry Disability Index (ODI) Score | 37.9 units on a scale | Standard Deviation 9.7 |
| Opana Then Placebo Then Darvocet | Oswestry Disability Index (ODI) Score | 98.4 units on a scale | Standard Deviation 5.7 |
| Placebo Then Opana Then Darvocet | Oswestry Disability Index (ODI) Score | 38.0 units on a scale | Standard Deviation 6.6 |
| Placebo Then Darvocet Then Opana | Oswestry Disability Index (ODI) Score | 44.1 units on a scale | Standard Deviation 9.7 |
| Darvocet Then Opana Then Placebo | Oswestry Disability Index (ODI) Score | 37.0 units on a scale | Standard Deviation 2.8 |
| Darvocet Then Placebo Then Opana | Oswestry Disability Index (ODI) Score | 29.7 units on a scale | Standard Deviation 13.3 |
Secondary
Patient Global Assessment (PGA)
Subjects were asked to rate their low back pain according to the PGA. PGA is the impact of disease activity. PGA was measured on a 5-point scale, where 1=very good, 2=good, 3=fair, 4=poor, and 5=very poor.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Patient Global Assessment (PGA) | 2.8 units on a scale | Standard Deviation 0.6 |
| Opana Then Placebo Then Darvocet | Patient Global Assessment (PGA) | 2.8 units on a scale | Standard Deviation 1 |
| Placebo Then Opana Then Darvocet | Patient Global Assessment (PGA) | 3.1 units on a scale | Standard Deviation 1.2 |
| Placebo Then Darvocet Then Opana | Patient Global Assessment (PGA) | 2.6 units on a scale | Standard Deviation 0.5 |
| Darvocet Then Opana Then Placebo | Patient Global Assessment (PGA) | 3.3 units on a scale | Standard Deviation 0.5 |
| Darvocet Then Placebo Then Opana | Patient Global Assessment (PGA) | 2.6 units on a scale | Standard Deviation 1.1 |
Secondary
Recovery Time
After the subject completed the treadmill test they were asked to immediately return to the seated position. At this point a timer was started. When the subjects pain level returned to baseline (level of pain subject felt in a seated position before walking) the time was stopped. This was recorded as recovery time. Maximum recovery time is 15 minutes.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Recovery Time | 1.10 minutes | Standard Deviation 0.98 |
| Opana Then Placebo Then Darvocet | Recovery Time | 1.50 minutes | Standard Deviation 1.37 |
| Placebo Then Opana Then Darvocet | Recovery Time | 2.02 minutes | Standard Deviation 2.68 |
| Placebo Then Darvocet Then Opana | Recovery Time | 1.58 minutes | Standard Deviation 1.22 |
| Darvocet Then Opana Then Placebo | Recovery Time | 2.15 minutes | Standard Deviation 1.18 |
| Darvocet Then Placebo Then Opana | Recovery Time | 1.57 minutes | Standard Deviation 1.19 |
Secondary
Roland Morris Disability Questionnaire (RMDQ)
The RMDQ consists of 24 yes/no statements about activity limitations due to back pain. These questions center on movement, ambulation, and self-care activities. Positive (yes) answers each contribute 1 point to cumulative score with total scores ranging from 0 (no disability) to 24 (severely disabled).
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Roland Morris Disability Questionnaire (RMDQ) | 12.8 units on a scale | Standard Deviation 4.4 |
| Opana Then Placebo Then Darvocet | Roland Morris Disability Questionnaire (RMDQ) | 15.3 units on a scale | Standard Deviation 5 |
| Placebo Then Opana Then Darvocet | Roland Morris Disability Questionnaire (RMDQ) | 13.2 units on a scale | Standard Deviation 4.1 |
| Placebo Then Darvocet Then Opana | Roland Morris Disability Questionnaire (RMDQ) | 15.2 units on a scale | Standard Deviation 2.7 |
| Darvocet Then Opana Then Placebo | Roland Morris Disability Questionnaire (RMDQ) | 13.7 units on a scale | Standard Deviation 3.6 |
| Darvocet Then Placebo Then Opana | Roland Morris Disability Questionnaire (RMDQ) | 7.4 units on a scale | Standard Deviation 4.3 |
Secondary
Swiss Spinal Stenosis Score- Physical Function
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The physical function section is a series of 5 questions (maximum 4 points per question) and asks to rate function for each question based on comfortably, sometimes with pain, always with pain, no functional ability. The total score (max=20) is divided by five. The maximum score for the physical function section (max=4) indicates no ability to function.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Swiss Spinal Stenosis Score- Physical Function | 2.5 units on a scale | Standard Deviation 0.4 |
| Opana Then Placebo Then Darvocet | Swiss Spinal Stenosis Score- Physical Function | 2.5 units on a scale | Standard Deviation 0.2 |
| Placebo Then Opana Then Darvocet | Swiss Spinal Stenosis Score- Physical Function | 2.6 units on a scale | Standard Deviation 0.6 |
| Placebo Then Darvocet Then Opana | Swiss Spinal Stenosis Score- Physical Function | 2.6 units on a scale | Standard Deviation 0.5 |
| Darvocet Then Opana Then Placebo | Swiss Spinal Stenosis Score- Physical Function | 2.6 units on a scale | Standard Deviation 0.2 |
| Darvocet Then Placebo Then Opana | Swiss Spinal Stenosis Score- Physical Function | 2.2 units on a scale | Standard Deviation 0.2 |
Secondary
Swiss Spinal Stenosis Score- Symptom Severity
The SSS is a series of questions asking about symptom severity, physical function, and satisfaction. The symptom severity section is a set of 7 questions (maximum score is 5 points per question) and asks to rate pain for each question based on no pain, mild, moderate, severe or very severe pain. The total score (maximum=35) is added up and divided by seven. The maximum score for the symptom severity section (score=5) indicates very severe symptom severity.
Time frame: study visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Swiss Spinal Stenosis Score- Symptom Severity | 2.6 units on a scale | Standard Deviation 0.6 |
| Opana Then Placebo Then Darvocet | Swiss Spinal Stenosis Score- Symptom Severity | 2.9 units on a scale | Standard Deviation 0.6 |
| Placebo Then Opana Then Darvocet | Swiss Spinal Stenosis Score- Symptom Severity | 3.2 units on a scale | Standard Deviation 0.3 |
| Placebo Then Darvocet Then Opana | Swiss Spinal Stenosis Score- Symptom Severity | 3.2 units on a scale | Standard Deviation 0.7 |
| Darvocet Then Opana Then Placebo | Swiss Spinal Stenosis Score- Symptom Severity | 3.6 units on a scale | Standard Deviation 0.5 |
| Darvocet Then Placebo Then Opana | Swiss Spinal Stenosis Score- Symptom Severity | 2.9 units on a scale | Standard Deviation 0.6 |
Secondary
Total Distance
Subjects were instructed to walk on the treadmill and to tell the research coordinator to stop testing when they reached the point at which they typically would need to stop and sit down, or until 15 minutes had elapsed. When the subject reached their maximum distance, the treadmill testing was stopped. This was recorded as total distance based on number of minutes and seconds walked. Minutes was converted to meters based on calculation of defined speed of the treadmill.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Total Distance | 266.6 meters | Standard Deviation 191.3 |
| Opana Then Placebo Then Darvocet | Total Distance | 249.5 meters | Standard Deviation 109.4 |
| Placebo Then Opana Then Darvocet | Total Distance | 177.9 meters | Standard Deviation 139.1 |
| Placebo Then Darvocet Then Opana | Total Distance | 290.1 meters | Standard Deviation 176 |
| Darvocet Then Opana Then Placebo | Total Distance | 160.8 meters | Standard Deviation 96.5 |
| Darvocet Then Placebo Then Opana | Total Distance | 294.8 meters | Standard Deviation 133.2 |
Secondary
Visual Analog Scale (VAS)
The VAS asked subjects to place a mark indicative of their low back pain during the past day on a 100mm line, with 0mm representing no pain and 100mm representing extreme pain.
Time frame: study visit
Population: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Opana Then Darvocet Then Placebo | Visual Analog Scale (VAS) | 51.3 units on a scale | Standard Deviation 22 |
| Opana Then Placebo Then Darvocet | Visual Analog Scale (VAS) | 57.9 units on a scale | Standard Deviation 25.7 |
| Placebo Then Opana Then Darvocet | Visual Analog Scale (VAS) | 56.2 units on a scale | Standard Deviation 28.6 |
| Placebo Then Darvocet Then Opana | Visual Analog Scale (VAS) | 46.7 units on a scale | Standard Deviation 24 |
| Darvocet Then Opana Then Placebo | Visual Analog Scale (VAS) | 63.3 units on a scale | Standard Deviation 31 |
| Darvocet Then Placebo Then Opana | Visual Analog Scale (VAS) | 55.1 units on a scale | Standard Deviation 30.7 |