Insomnia, Osteoarthritis
Conditions
Keywords
eszopiclone, insomnia
Brief summary
This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.
Interventions
DRUGPlacebo
3mg placebo capsule, once daily at bedtime
DRUGEszopiclone
3mg capsule, once daily at bedtime
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-64 * Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 osteoarthritis (OA) * Report at least typical arthritic pain\>4 out of 10 (0=no pain, 10=the most extreme pain imaginable) * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Sleep Disorders, Revised definition (ICSD-R) criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis * Insomnia symptoms must include problems with middle of the night awakenings * Insomnia symptom duration \> 6 months * Baseline, 2-week, sleep diary average wake after sleep onset time \>30 minutes * Baseline self-reported total sleep time \< 6.5 hours per night * Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study
Exclusion criteria
* Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc) * Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc) * Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome) * Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder * History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse * Pregnancy or plans to become pregnant within 6 months * Intraarticular steroid injection within the past month * Regular (\>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months * Regular (\> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month * Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study * Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions * Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information * Regular tobacco or nicotine use * Heavy caffeine use \[(\>2 cups of coffee/day (equivalent) * History of previous allergic reaction or severe side effects to sedative hypnotics * Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir) * In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, Tetrahydrocannabinol (THC), alcohol, and stimulants), c) abnormal liver enzyme panel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | Mean of baseline, 6 week follow-up and 12 week follow-up | The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain. |
| TST as Assessed by Actigraphy | Mean of baseline, 6 week follow-up, and 12 week follow-up | Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep |
| Sleep Efficiency as Assessed by Actigraphy | Mean of baseline, 6 week follow-up, and 12 week follow-up | Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%. |
| Sleep Latency as Assessed by Actigraphy | Mean of baseline, 6 week follow-up, and 12 week follow-up | Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch). |
| Insomnia Severity Index (ISI) Mean Total Scores | Mean of baseline, 6 week follow-up, and 12 week follow-up | The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia |
| Diffuse Noxious Inhibitory Control (DNIC) Index Scores | Mean of baseline, 6 week follow-up and 12 week follow-up | PPTh:a somedic algometer's 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he first felt pain. PPTh ratings were obtained on right brachioradialis & right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh \[i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)\*100\]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes. |
| Temporal Summation (TS) | Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C | TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise & fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale & may terminate the procedure at any time.100=max tolerable intensity |
| Mean Level of Pain Experienced Throughout the Day | Mean of baseline, 6 week follow-up and 12 week follow-up | Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense |
| Wake After Sleep Onset (WASO) | Mean of baseline, 6 week follow-up, and 12 week follow-up | Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes |
| Time in Bed | Mean of baseline, 6 week follow-up, and 12 week follow-up | Total time in bed, in minutes |
| Sleep Latency (SL) | Mean of baseline, 6 week follow-up, and 12 week follow-up | Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary) |
| Number of Awakenings | Mean of baseline, 6 week follow-up, and 12 week follow-up | As recorded in daily sleep diary |
| Total Sleep Time (TST) | Mean of baseline, 6 week follow-up, and 12 week follow-up | minutes spent asleep as recorded in daily sleep diary |
| Sleep Efficiency (SE) | Mean of baseline, 6 week follow-up, and 12 week follow-up | \[(TST/ TIB)X 100\], (%) as recorded in daily sleep diary |
| Sleep Quality (SQ) | Mean of baseline, 6 week follow-up, and 12 week follow-up | As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing) |
| WASO as Assessed by Actigraphy | Mean of baseline, 6 week follow-up, and 12 week follow-up | Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heat Pain Tolerance (HPTOL) | Mean of baseline, 6 week follow-up and 12 week follow-up | Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus becomes intolerable. The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded. |
| Pressure Pain Threshold | Mean of baseline, 6 week follow-up and 12 week follow-up | A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer's 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he first felt pain. PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli |
| Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | Mean of baseline, 6 week follow-up and 12 week follow-up | The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability. |
| Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | Mean of baseline, 6 week follow-up and 12 week follow-up | The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best. |
| Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | Mean of baseline, 6 week follow-up and 12 week follow-up | The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best. |
| Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | Mean of baseline, 6 week follow-up and 12 week follow-up | The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness. |
| Heat Pain Threshold | Mean of baseline, 6 week follow-up and 12 week follow-up | Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus first feels painful The temperature (degrees Celsius) at the time button is pushed is automatically recorded. |
Countries
United States
Participant flow
Pre-assignment details
105 were assessed for eligibility. 75 were excluded based on not meeting inclusion criteria. 30 were randomized to one of 2 arms. One subject after randomization ( to placebo condition) was determined to be ineligible due to failing sleep apnea entry criteria. They were removed from the study and did not contribute to baseline data.
Participants by arm
| Arm | Count |
|---|---|
| Eszopiclone Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks
Eszopiclone: 3mg capsule, once daily at bedtime | 14 |
| Placebo 3mg placebo capsule, once daily at bedtime for 12 weeks
Placebo: 3mg placebo capsule, once daily at bedtime | 15 |
| Total | 29 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Removed at baseline due to medical cond | 0 | 1 |
Baseline characteristics
| Characteristic | Placebo | Total | Eszopiclone |
|---|---|---|---|
| Age, Continuous | 52.93 years STANDARD_DEVIATION 6.64 | 53.76 years STANDARD_DEVIATION 5.94 | 54.64 years STANDARD_DEVIATION 5.18 |
| BMI | 31.36 kg/m^2 STANDARD_DEVIATION 6.53 | 30.42 kg/m^2 STANDARD_DEVIATION 5.91 | 29.41 kg/m^2 STANDARD_DEVIATION 5.21 |
| Duration of OA | 108.5 months STANDARD_DEVIATION 95.11 | 95.6 months STANDARD_DEVIATION 95.69 | 87.7 months STANDARD_DEVIATION 98.06 |
| Kellgren Lawrence OA grade Left Knee | 1.79 units on a scale STANDARD_DEVIATION 1.05 | 1.93 units on a scale STANDARD_DEVIATION 1.05 | 2.07 units on a scale STANDARD_DEVIATION 1.07 |
| Kellgren Lawrence OA grade Right knee | 1.53 units on a scale STANDARD_DEVIATION 0.91 | 1.79 units on a scale STANDARD_DEVIATION 0.92 | 2.08 units on a scale STANDARD_DEVIATION 0.86 |
| Kellgren Lawrence OA grade >=3 in either knee | 4 participants | 10 participants | 6 participants |
| Region of Enrollment United States | 15 participants | 29 participants | 14 participants |
| Sex: Female, Male Female | 8 Participants | 19 Participants | 11 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 14 |
| other Total, other adverse events | 5 / 16 | 7 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
Diffuse Noxious Inhibitory Control (DNIC) Index Scores
PPTh:a somedic algometer's 1cm2 rubber probe was placed over muscle belly, with pressure increasing steadily at constant rate (30kPA/Sec), until subject indicated that s/he first felt pain. PPTh ratings were obtained on right brachioradialis & right trapezius in a random order (average was taken from both areas at each time point). During each cold pressor task, participants immersed contralateral hand (left) up to wrist, in a circulating cold water bath maintained at 4°C. 20 seconds after commencing hand immersion, PPTh was re-assessed on either right brachioradialis or right trapezius (the same site as baseline assessment). After PPTh assessment, participants removed hands from water. DNIC was measured as the % change in PPTh during cold pressor, relative to baseline PPTh \[i.e., (mean PPTh during cold pressor / mean PPTh prior to cold pressor)\*100\]. Increase in PPTh during cold pressor (i.e., percentage scores above 100) reflects normal functioning of pain-inhibitory processes.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | Baseline | 1.23 percentage change of PPTh | Standard Deviation 0.3 |
| Placebo | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | 6 week follow-up | 1.26 percentage change of PPTh | Standard Deviation 0.31 |
| Placebo | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | 12 week follow-up | 1.16 percentage change of PPTh | Standard Deviation 0.24 |
| Eszopiclone | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | Baseline | 1.19 percentage change of PPTh | Standard Deviation 0.15 |
| Eszopiclone | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | 6 week follow-up | 1.23 percentage change of PPTh | Standard Deviation 0.25 |
| Eszopiclone | Diffuse Noxious Inhibitory Control (DNIC) Index Scores | 12 week follow-up | 1.14 percentage change of PPTh | Standard Deviation 0.19 |
Primary
Insomnia Severity Index (ISI) Mean Total Scores
The ISI is made up of 7 questions, each possible of earning a score of 0-4, making the total range 0-28, where 0 indicates no severity/no problem with sleep and therefore no insomnia, or 28, being very severe with the highest level of insomnia
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Insomnia Severity Index (ISI) Mean Total Scores | Baseline | 15.64 units on a scale | Standard Deviation 6.02 |
| Placebo | Insomnia Severity Index (ISI) Mean Total Scores | 6 week follow-up | 12.57 units on a scale | Standard Deviation 4.65 |
| Placebo | Insomnia Severity Index (ISI) Mean Total Scores | 12 week follow-up | 10.25 units on a scale | Standard Deviation 5.19 |
| Eszopiclone | Insomnia Severity Index (ISI) Mean Total Scores | Baseline | 16.64 units on a scale | Standard Deviation 4.98 |
| Eszopiclone | Insomnia Severity Index (ISI) Mean Total Scores | 6 week follow-up | 10.71 units on a scale | Standard Deviation 6.38 |
| Eszopiclone | Insomnia Severity Index (ISI) Mean Total Scores | 12 week follow-up | 13 units on a scale | Standard Deviation 6.33 |
Primary
Mean Level of Pain Experienced Throughout the Day
Assessed using a Daily Pain Diary with a scale 0-100, 0 being no pain, 100 being the most severe/intense
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Level of Pain Experienced Throughout the Day | Baseline | 48.79 units on a scale | Standard Deviation 19.63 |
| Placebo | Mean Level of Pain Experienced Throughout the Day | 6 week follow-up | 42.21 units on a scale | Standard Deviation 18.34 |
| Placebo | Mean Level of Pain Experienced Throughout the Day | 12 week follow-up | 38.12 units on a scale | Standard Deviation 19.11 |
| Eszopiclone | Mean Level of Pain Experienced Throughout the Day | Baseline | 52.40 units on a scale | Standard Deviation 18.87 |
| Eszopiclone | Mean Level of Pain Experienced Throughout the Day | 6 week follow-up | 44.43 units on a scale | Standard Deviation 28.39 |
| Eszopiclone | Mean Level of Pain Experienced Throughout the Day | 12 week follow-up | 42.88 units on a scale | Standard Deviation 25.53 |
Primary
Number of Awakenings
As recorded in daily sleep diary
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Number of Awakenings | Baseline | 3.53 number of awakenings | Standard Deviation 1.84 |
| Placebo | Number of Awakenings | 6 week follow-up | 3.06 number of awakenings | Standard Deviation 1.27 |
| Placebo | Number of Awakenings | 12 week follow-up | 2.38 number of awakenings | Standard Deviation 0.78 |
| Eszopiclone | Number of Awakenings | Baseline | 3.70 number of awakenings | Standard Deviation 2.11 |
| Eszopiclone | Number of Awakenings | 6 week follow-up | 3.11 number of awakenings | Standard Deviation 1.76 |
| Eszopiclone | Number of Awakenings | 12 week follow-up | 3.42 number of awakenings | Standard Deviation 1.99 |
Primary
Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Pain was assessed on a scale of 0-100, with 0 being absolutely no pain and 100 being maximum pain.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | Baseline | 21.62 units on a scale | Standard Deviation 10.75 |
| Placebo | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | 6 week follow-up | 19.18 units on a scale | Standard Deviation 12.03 |
| Placebo | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | 12 week follow-up | 14.85 units on a scale | Standard Deviation 11.04 |
| Eszopiclone | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | Baseline | 24.88 units on a scale | Standard Deviation 13.79 |
| Eszopiclone | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | 6 week follow-up | 24.41 units on a scale | Standard Deviation 13.74 |
| Eszopiclone | Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale | 12 week follow-up | 19.89 units on a scale | Standard Deviation 14.15 |
Primary
Sleep Efficiency as Assessed by Actigraphy
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep efficiency is the index of sleep percentage recorded, equal to total sleep time divided by the time in bed X 100 = X%.
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Efficiency as Assessed by Actigraphy | Baseline | 73.32 percentage of time asleep | Standard Deviation 12.34 |
| Placebo | Sleep Efficiency as Assessed by Actigraphy | 6 week follow-up | 74.77 percentage of time asleep | Standard Deviation 8.87 |
| Placebo | Sleep Efficiency as Assessed by Actigraphy | 12 week follow-up | 73.95 percentage of time asleep | Standard Deviation 14.15 |
| Eszopiclone | Sleep Efficiency as Assessed by Actigraphy | Baseline | 76.83 percentage of time asleep | Standard Deviation 8.74 |
| Eszopiclone | Sleep Efficiency as Assessed by Actigraphy | 6 week follow-up | 79.94 percentage of time asleep | Standard Deviation 7.49 |
| Eszopiclone | Sleep Efficiency as Assessed by Actigraphy | 12 week follow-up | 75.16 percentage of time asleep | Standard Deviation 7.58 |
Primary
Sleep Efficiency (SE)
\[(TST/ TIB)X 100\], (%) as recorded in daily sleep diary
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Efficiency (SE) | Baseline | 55.54 percentage of efficient sleep | Standard Deviation 62.44 |
| Placebo | Sleep Efficiency (SE) | 6 week follow-up | 66.31 percentage of efficient sleep | Standard Deviation 24.01 |
| Placebo | Sleep Efficiency (SE) | 12 week follow-up | 80.07 percentage of efficient sleep | Standard Deviation 11.65 |
| Eszopiclone | Sleep Efficiency (SE) | Baseline | 62.44 percentage of efficient sleep | Standard Deviation 20.73 |
| Eszopiclone | Sleep Efficiency (SE) | 6 week follow-up | 77.48 percentage of efficient sleep | Standard Deviation 15.32 |
| Eszopiclone | Sleep Efficiency (SE) | 12 week follow-up | 75.06 percentage of efficient sleep | Standard Deviation 19.3 |
Primary
Sleep Latency as Assessed by Actigraphy
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. Sleep latency is the time taken to fall asleep, or equal to lights out- sleep onset (sleep onset: time when sleep is first scored after lights out, first scorable epoch).
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Latency as Assessed by Actigraphy | Baseline | 46.25 minutes | Standard Deviation 58.44 |
| Placebo | Sleep Latency as Assessed by Actigraphy | 6 week follow-up | 39.31 minutes | Standard Deviation 48.31 |
| Placebo | Sleep Latency as Assessed by Actigraphy | 12 week follow-up | 24.71 minutes | Standard Deviation 27.42 |
| Eszopiclone | Sleep Latency as Assessed by Actigraphy | Baseline | 26.79 minutes | Standard Deviation 24.73 |
| Eszopiclone | Sleep Latency as Assessed by Actigraphy | 6 week follow-up | 24.87 minutes | Standard Deviation 17.06 |
| Eszopiclone | Sleep Latency as Assessed by Actigraphy | 12 week follow-up | 38.89 minutes | Standard Deviation 23.49 |
Primary
Sleep Latency (SL)
Sleep Latency: time taken to fall asleep, in minutes (as recorded in daily sleep diary)
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Latency (SL) | Baseline | 58.33 minutes | Standard Deviation 51.01 |
| Placebo | Sleep Latency (SL) | 6 week follow-up | 45.00 minutes | Standard Deviation 41.96 |
| Placebo | Sleep Latency (SL) | 12 week follow-up | 31.38 minutes | Standard Deviation 26.98 |
| Eszopiclone | Sleep Latency (SL) | Baseline | 47.50 minutes | Standard Deviation 30.21 |
| Eszopiclone | Sleep Latency (SL) | 6 week follow-up | 33.33 minutes | Standard Deviation 21.5 |
| Eszopiclone | Sleep Latency (SL) | 12 week follow-up | 41.42 minutes | Standard Deviation 40.28 |
Primary
Sleep Quality (SQ)
As recorded in daily sleep diary. Visual analog scales (VAS) Sleep Quality Ratings 0-100, 0= extremely poor sleep quality, (shallow and unrefreshing) and 100=excellent sleep quality (deep and refreshing)
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Sleep Quality (SQ) | Baseline | 44.40 units on a scale | Standard Deviation 18.86 |
| Placebo | Sleep Quality (SQ) | 6 week follow-up | 52.46 units on a scale | Standard Deviation 19.96 |
| Placebo | Sleep Quality (SQ) | 12 week follow-up | 59.16 units on a scale | Standard Deviation 23.12 |
| Eszopiclone | Sleep Quality (SQ) | Baseline | 37.90 units on a scale | Standard Deviation 13.89 |
| Eszopiclone | Sleep Quality (SQ) | 6 week follow-up | 55.33 units on a scale | Standard Deviation 19.93 |
| Eszopiclone | Sleep Quality (SQ) | 12 week follow-up | 55.71 units on a scale | Standard Deviation 11.85 |
Primary
Temporal Summation (TS)
TS :maximum windup pain rating - first windup pain rating (0-100). Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to left forearm. In order to assess temporal summation, three sequences of 10 heat pulses each (with stimulus temperatures of 46 degrees C, 48 degrees C, and 50 degrees C, in random order) were applied to left dorsal forearm. The thermode remains in fixed position during administration of 10 heat pulses that constitute a sequence. Within each sequence, successive thermal pulses at a given temperature are delivered for a duration of approximately 0.5 sec each, with a 2.5-sec inter-pulse interval. The rate of rise & fall of the thermode temp. is set at the device max .of 10 degrees C / S. Subjects verbally rate the perceived intensity of each thermal pulse on a 0-100 rating scale & may terminate the procedure at any time.100=max tolerable intensity
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Temporal Summation (TS) | 6 week follow-up 46 degrees C | 6.41 units on a scale | Standard Deviation 9.69 |
| Placebo | Temporal Summation (TS) | 12 week follow-up 48 degrees C | 5.23 units on a scale | Standard Deviation 8.7 |
| Placebo | Temporal Summation (TS) | Baseline 48 degrees C | 20.40 units on a scale | Standard Deviation 41.9 |
| Placebo | Temporal Summation (TS) | Baseline 50 degrees C | 17.06 units on a scale | Standard Deviation 23.09 |
| Placebo | Temporal Summation (TS) | 12 week follow-up 46 degrees C | 5.22 units on a scale | Standard Deviation 7.45 |
| Placebo | Temporal Summation (TS) | 6 week follow-up 50 degrees C | 13.27 units on a scale | Standard Deviation 19.66 |
| Placebo | Temporal Summation (TS) | 6 week follow-up 48 degrees C | 5.75 units on a scale | Standard Deviation 8.72 |
| Placebo | Temporal Summation (TS) | 12 week follow-up 50 degrees C | 18.84 units on a scale | Standard Deviation 23.82 |
| Placebo | Temporal Summation (TS) | Baseline 46 degrees C | 9.20 units on a scale | Standard Deviation 16.08 |
| Eszopiclone | Temporal Summation (TS) | 12 week follow-up 50 degrees C | 20.77 units on a scale | Standard Deviation 28.92 |
| Eszopiclone | Temporal Summation (TS) | Baseline 46 degrees C | 7.80 units on a scale | Standard Deviation 12.93 |
| Eszopiclone | Temporal Summation (TS) | 6 week follow-up 46 degrees C | 6.50 units on a scale | Standard Deviation 7.47 |
| Eszopiclone | Temporal Summation (TS) | 12 week follow-up 46 degrees C | 3.33 units on a scale | Standard Deviation 7.07 |
| Eszopiclone | Temporal Summation (TS) | Baseline 48 degrees C | 4.72 units on a scale | Standard Deviation 6.77 |
| Eszopiclone | Temporal Summation (TS) | 6 week follow-up 48 degrees C | 8.11 units on a scale | Standard Deviation 11.38 |
| Eszopiclone | Temporal Summation (TS) | 12 week follow-up 48 degrees C | 4.55 units on a scale | Standard Deviation 4.13 |
| Eszopiclone | Temporal Summation (TS) | Baseline 50 degrees C | 21.00 units on a scale | Standard Deviation 20.25 |
| Eszopiclone | Temporal Summation (TS) | 6 week follow-up 50 degrees C | 18.00 units on a scale | Standard Deviation 20.3 |
Primary
Time in Bed
Total time in bed, in minutes
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Time in Bed | Baseline | 464.00 minutes | Standard Deviation 134.31 |
| Placebo | Time in Bed | 6 week follow-up | 506.00 minutes | Standard Deviation 120.22 |
| Placebo | Time in Bed | 12 week follow-up | 523.33 minutes | Standard Deviation 128.55 |
| Eszopiclone | Time in Bed | 12 week follow-up | 592.85 minutes | Standard Deviation 113.39 |
| Eszopiclone | Time in Bed | Baseline | 608.00 minutes | Standard Deviation 243.48 |
| Eszopiclone | Time in Bed | 6 week follow-up | 577.77 minutes | Standard Deviation 130.26 |
Primary
Total Sleep Time (TST)
minutes spent asleep as recorded in daily sleep diary
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Total Sleep Time (TST) | Baseline | 255.66 minutes | Standard Deviation 172.57 |
| Placebo | Total Sleep Time (TST) | 6 week follow-up | 339.33 minutes | Standard Deviation 161.04 |
| Placebo | Total Sleep Time (TST) | 12 week follow-up | 409.44 minutes | Standard Deviation 80.98 |
| Eszopiclone | Total Sleep Time (TST) | Baseline | 370.50 minutes | Standard Deviation 184.98 |
| Eszopiclone | Total Sleep Time (TST) | 6 week follow-up | 454.44 minutes | Standard Deviation 178.68 |
| Eszopiclone | Total Sleep Time (TST) | 12 week follow-up | 437.14 minutes | Standard Deviation 118.73 |
Primary
TST as Assessed by Actigraphy
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. TST recorded by device = total minutes spent asleep
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | TST as Assessed by Actigraphy | Baseline | 340.07 minutes | Standard Deviation 71.23 |
| Placebo | TST as Assessed by Actigraphy | 6 week follow-up | 337.93 minutes | Standard Deviation 75 |
| Placebo | TST as Assessed by Actigraphy | 12 week follow-up | 336.84 minutes | Standard Deviation 87.63 |
| Eszopiclone | TST as Assessed by Actigraphy | Baseline | 367.95 minutes | Standard Deviation 79.73 |
| Eszopiclone | TST as Assessed by Actigraphy | 6 week follow-up | 405.88 minutes | Standard Deviation 79.29 |
| Eszopiclone | TST as Assessed by Actigraphy | 12 week follow-up | 394.77 minutes | Standard Deviation 96.86 |
Primary
Wake After Sleep Onset (WASO)
Total minutes of wakefulness recorded after sleep onset. (Recorded in Daily Sleep Diary) WASO= time awake in the middle of the night, not counting SL or time in bed after awakening. Recorded in minutes
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Wake After Sleep Onset (WASO) | Baseline | 117.33 minutes | Standard Deviation 108.09 |
| Placebo | Wake After Sleep Onset (WASO) | 6 week follow-up | 81.00 minutes | Standard Deviation 98.76 |
| Placebo | Wake After Sleep Onset (WASO) | 12 week follow-up | 61.94 minutes | Standard Deviation 55.59 |
| Eszopiclone | Wake After Sleep Onset (WASO) | Baseline | 88.0 minutes | Standard Deviation 57.26 |
| Eszopiclone | Wake After Sleep Onset (WASO) | 6 week follow-up | 65.56 minutes | Standard Deviation 67.28 |
| Eszopiclone | Wake After Sleep Onset (WASO) | 12 week follow-up | 58.57 minutes | Standard Deviation 51.85 |
Primary
WASO as Assessed by Actigraphy
Subjects wore a Mini Mitter Actiwatch for two continuous weeks at each assessment periods to provide an objective index compared to the assessments made by daily sleep journal. Device is lightweight and worn on non-dominant wrist and contains and omni-directional accelerometer. The accelerometer records the occurrence and degree of motion with a minimal resultant force of .01g. Data are stored as activity counts within a specified epoch. WASO recorded by device = total minutes of wakefulness after sleep onset, in minutes.
Time frame: Mean of baseline, 6 week follow-up, and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | WASO as Assessed by Actigraphy | Baseline | 64.70 minutes | Standard Deviation 39.14 |
| Placebo | WASO as Assessed by Actigraphy | 6 week follow-up | 56.30 minutes | Standard Deviation 25.34 |
| Placebo | WASO as Assessed by Actigraphy | 12 week follow-up | 59.70 minutes | Standard Deviation 39.18 |
| Eszopiclone | WASO as Assessed by Actigraphy | Baseline | 59.43 minutes | Standard Deviation 15.81 |
| Eszopiclone | WASO as Assessed by Actigraphy | 6 week follow-up | 56.06 minutes | Standard Deviation 250.8 |
| Eszopiclone | WASO as Assessed by Actigraphy | 12 week follow-up | 65.29 minutes | Standard Deviation 17.99 |
Secondary
Heat Pain Threshold
Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitizationHPTh was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of heat pain threshold were conducted. Averages of both trials are presented from respective time point below. Subjects push a button when the stimulus first feels painful The temperature (degrees Celsius) at the time button is pushed is automatically recorded.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heat Pain Threshold | Baseline | 43.38 degrees Celsius | Standard Deviation 4.71 |
| Placebo | Heat Pain Threshold | 6 week follow-up | 43.41 degrees Celsius | Standard Deviation 5.41 |
| Placebo | Heat Pain Threshold | 12 week follow-up | 43.31 degrees Celsius | Standard Deviation 4.61 |
| Eszopiclone | Heat Pain Threshold | Baseline | 42.77 degrees Celsius | Standard Deviation 3.51 |
| Eszopiclone | Heat Pain Threshold | 6 week follow-up | 42.19 degrees Celsius | Standard Deviation 3.95 |
| Eszopiclone | Heat Pain Threshold | 12 week follow-up | 42.49 degrees Celsius | Standard Deviation 4.38 |
Secondary
Heat Pain Tolerance (HPTOL)
Contact heat stimuli at non tissue damaging temperatures were delivered using computer driven, peltier-element-based stimulator (Medoc, TSA II), with a 9 cm2 probe applied to the left forearm. The thermode was affixed snugly via Velcro straps to ensure even skin contact and repositioned to an adjacent site after each trial to minimize sensitization. HPTOL was assessed on the left ventral forearm using an ascending method of limits paradigm; from a non-painful 32°C baseline, the temperature was steadily increased at 0.5°C/sec. Two trials of HPTOL were conducted. An average of both trials at each respective time point is presented below. Subjects push a button when the stimulus becomes intolerable. The temperature (degrees Celsius) at the time button is pushed to terminate the stimulation is automatically recorded.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Heat Pain Tolerance (HPTOL) | Baseline | 47.65 degrees Celsius | Standard Deviation 2.28 |
| Placebo | Heat Pain Tolerance (HPTOL) | 6 week follow-up | 47.54 degrees Celsius | Standard Deviation 2.26 |
| Placebo | Heat Pain Tolerance (HPTOL) | 12 week follow-up | 47.92 degrees Celsius | Standard Deviation 2.24 |
| Eszopiclone | Heat Pain Tolerance (HPTOL) | Baseline | 46.56 degrees Celsius | Standard Deviation 2.8 |
| Eszopiclone | Heat Pain Tolerance (HPTOL) | 6 week follow-up | 46.87 degrees Celsius | Standard Deviation 3.56 |
| Eszopiclone | Heat Pain Tolerance (HPTOL) | 12 week follow-up | 46.67 degrees Celsius | Standard Deviation 3.93 |
Secondary
Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Joint Stiffness was assessed on a VAS scale of 0-20, with 0 being no joint stiffness, and 20 being maximum stiffness.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | Baseline | 10.17 units on a scale | Standard Deviation 5.6 |
| Placebo | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | 6 week follow-up | 7.55 units on a scale | Standard Deviation 5.74 |
| Placebo | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | 12 week follow-up | 6.86 units on a scale | Standard Deviation 5.89 |
| Eszopiclone | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | 6 week follow-up | 12.17 units on a scale | Standard Deviation 4.41 |
| Eszopiclone | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | Baseline | 12.86 units on a scale | Standard Deviation 5.05 |
| Eszopiclone | Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale | 12 week follow-up | 11.32 units on a scale | Standard Deviation 5.61 |
Secondary
Pressure Pain Threshold
A Somedic algometer was used to assess pressure pain threshold (PPTh) similar to previous studies. The algometer's 1cm2 rubber probe was placed over the muscle belly, with the pressure increased steadily at a constant rate (30kPA/Sec), until the subject indicated that s/he first felt pain. PPTh was assessed 2 times each, bilaterally, at (in a randomized order) the masseter muscle trapezius muscle, and at the proximal third of the brachioradialis muscle (forearm). The scores from each location were averaged for each participant at that respective time point. The same site was never stimulated consecutively. At least 90 s were maintained between successive stimuli
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pressure Pain Threshold | Baseline | 300.91 kPA | Standard Deviation 111.13 |
| Placebo | Pressure Pain Threshold | 6 week follow-up | 322.24 kPA | Standard Deviation 107.82 |
| Placebo | Pressure Pain Threshold | 12 week follow-up | 381.92 kPA | Standard Deviation 199.33 |
| Eszopiclone | Pressure Pain Threshold | Baseline | 267.93 kPA | Standard Deviation 111.5 |
| Eszopiclone | Pressure Pain Threshold | 6 week follow-up | 287.29 kPA | Standard Deviation 107.01 |
| Eszopiclone | Pressure Pain Threshold | 12 week follow-up | 309.15 kPA | Standard Deviation 81.16 |
Secondary
Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Mental Component Summary was used here as a global index of mental health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | Baseline | 50.40 units on a scale | Standard Deviation 9.56 |
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | 6 week follow-up | 51.68 units on a scale | Standard Deviation 7.73 |
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | 12 week follow-up | 50.71 units on a scale | Standard Deviation 5.89 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | Baseline | 45.78 units on a scale | Standard Deviation 7.88 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | 6 week follow-up | 45.86 units on a scale | Standard Deviation 7.06 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary | 12 week follow-up | 47.04 units on a scale | Standard Deviation 11.05 |
Secondary
Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
The SF-36 is a broad, well normed measure of quality of life, comprised of 36 questions aggregated into 8 domains/dimensions. The Physical Component Summary was used here as a global index of physical health functioning. Scale 0-100, with 0 being worst functional level, 100 being the best.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | Baseline | 57.61 units on a scale | Standard Deviation 25.91 |
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | 6 week follow-up | 60.60 units on a scale | Standard Deviation 27.48 |
| Placebo | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | 12 week follow-up | 65.00 units on a scale | Standard Deviation 21.69 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | Baseline | 52.73 units on a scale | Standard Deviation 23.38 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | 6 week follow-up | 49.44 units on a scale | Standard Deviation 28.94 |
| Eszopiclone | Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary | 12 week follow-up | 49.40 units on a scale | Standard Deviation 28.41 |
Secondary
Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
The WOMAC is a quality of scale life made up of three domains, pain, stiffness, and disability which each comprising of 5, 2, and 7 questions, respectively. A VAS was used for each subscale. Disability was assessed on a VAS of 0-100, with 0 being absolutely no disability and 100 being maximum disability.
Time frame: Mean of baseline, 6 week follow-up and 12 week follow-up
Population: Data was not included for all participants, as some were unable to complete the task or experienced technical difficulties.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | Baseline | 64.32 units on a scale | Standard Deviation 41.26 |
| Placebo | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | 6 week follow-up | 62.26 units on a scale | Standard Deviation 45.878 |
| Placebo | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | 12 week follow-up | 56.13 units on a scale | Standard Deviation 48.11 |
| Eszopiclone | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | Baseline | 74.69 units on a scale | Standard Deviation 46.18 |
| Eszopiclone | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | 6 week follow-up | 79.71 units on a scale | Standard Deviation 47.79 |
| Eszopiclone | Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale | 12 week follow-up | 70.44 units on a scale | Standard Deviation 50.75 |