Trial Outcomes & Findings for Lumbar Stenosis Outcomes Research (LUSTOR) (NCT NCT00638443)
NCT ID: NCT00638443
Last Updated: 2016-06-20
Results Overview
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.
COMPLETED
PHASE4
29 participants
10 days
2016-06-20
Participant Flow
Participants were recruited from the Neuromedicine Pain Treatment Center between May 2008 and February 2010
33 participants recruited; 4 excluded (did not meet inclusion criteria based on evoked pain being less than moderate intensity during treadmill ambulation).
Participant milestones
| Measure |
Pregabalin First, Diphenhydramine Second
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
|
Diphenhydramine First, Pregabalin Second
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
|---|---|---|
|
First Intervention
STARTED
|
14
|
15
|
|
First Intervention
COMPLETED
|
12
|
14
|
|
First Intervention
NOT COMPLETED
|
2
|
1
|
|
Washout
STARTED
|
12
|
14
|
|
Washout
COMPLETED
|
12
|
14
|
|
Washout
NOT COMPLETED
|
0
|
0
|
|
Second Intervention
STARTED
|
12
|
14
|
|
Second Intervention
COMPLETED
|
12
|
14
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Pregabalin First, Diphenhydramine Second
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days; washout 7 days; Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
|
Diphenhydramine First, Pregabalin Second
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days; washout 7 days; Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
|---|---|---|
|
First Intervention
Adverse Event
|
2
|
1
|
Baseline Characteristics
Lumbar Stenosis Outcomes Research (LUSTOR)
Baseline characteristics by cohort
| Measure |
All Study Participants
n=29 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
69.76 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 daysPopulation: The analyses included all enrolled randomized subjects according to the inclusion and exclusion criteria except for the three who withdrew from the trial prior to the completion of the study. One dropped out of the study due to an adverse event (dizziness).
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Time to First Symptoms of Moderate Pain
|
2.52 minutes
Standard Deviation 2.83
|
3.06 minutes
Standard Deviation 3.11
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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. 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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Final Pain as Measured by NRS
|
1.82 units on a scale
Standard Error .35
|
1.53 units on a scale
Standard Error .35
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Total Distance
|
237.49 meters
Standard Error 27.47
|
261.55 meters
Standard Error 27.47
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Recovery Time
|
2.36 minutes
Standard Error .43
|
3.15 minutes
Standard Error .43
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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 multiplied by the amount of time the subject walked.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Area Under the Curve
|
100.59 units on a scale * minutes
Standard Error 5.15
|
95.26 units on a scale * minutes
Standard Error 5.15
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Visual Analog Scale (VAS)
|
52.31 units on a scale
Standard Deviation 27.49
|
46.31 units on a scale
Standard Deviation 24.44
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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 total score range of 0-50; score of 0 indicates no disability and a score of 50 would indicate 100% disability.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Oswestry Disability Index (ODI) Score
|
37.77 units on a scale
Standard Error 2.76
|
36.49 units on a scale
Standard Error 2.76
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Swiss Spinal Stenosis (SSS) Score- Symptom Severity
|
3.09 units on a scale
Standard Error .12
|
2.94 units on a scale
Standard Error .12
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Swiss Spinal Stenosis- Physical Function
|
2.40 units on a scale
Standard Error 0.09
|
2.94 units on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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 pain interference sub-scales. The final interference score is an average of the seven sub-scales (0 indicating no interference and 10 indicating complete interference).
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Modified Brief Pain Inventory (mBPI)- Interference Score
|
3.70 units on a scale
Standard Error 0.42
|
3.58 units on a scale
Standard Error 0.42
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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).
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Roland Morris Disability Questionnaire
|
12.98 units on a scale
Standard Error .92
|
11.48 units on a scale
Standard Error .92
|
SECONDARY outcome
Timeframe: 10 daysPopulation: Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
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.
Outcome measures
| Measure |
Pregabalin
n=26 Participants
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 Participants
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
Patient Global Assessment (PGA)
|
2.75 units on a scale
Standard Error .19
|
2.83 units on a scale
Standard Error 0.19
|
Adverse Events
Pregabalin
Diphenhydramine
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin
n=26 participants at risk
Pregabalin started at 75mg twice daily for 3 days; pregabalin increased to 150mg twice daily for 7 days; pregabalin reduced to 75mg twice daily for 3 days.
|
Diphenhydramine
n=26 participants at risk
Diphenhydramine started at 6.25mg twice daily for 3 days; diphenhydramine increased to 12.5mg twice daily for 7 days; diphenhydramine reduced to 6.25mg twice daily for 3 days.
|
|---|---|---|
|
General disorders
Dizziness
|
34.6%
9/26 • Number of events 9
|
0.00%
0/26
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
3/26 • Number of events 3
|
7.7%
2/26 • Number of events 2
|
|
General disorders
Somnolence
|
19.2%
5/26 • Number of events 5
|
7.7%
2/26 • Number of events 2
|
|
General disorders
Dry mouth
|
15.4%
4/26 • Number of events 4
|
0.00%
0/26
|
|
Gastrointestinal disorders
Nausea
|
3.8%
1/26 • Number of events 1
|
7.7%
2/26 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Peripheral edema
|
19.2%
5/26 • Number of events 5
|
3.8%
1/26 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place