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Trial record 19 of 448 for:    diphenhydramine

Lumbar Stenosis Outcomes Research (LUSTOR) (LUSTOR)

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ClinicalTrials.gov Identifier: NCT00638443
Recruitment Status : Completed
First Posted : March 19, 2008
Results First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
John Markman, University of Rochester

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Lumbar Spinal Stenosis
Interventions Drug: Pregabalin
Drug: Diphenhydramine
Enrollment 29
Recruitment Details Participants were recruited from the Neuromedicine Pain Treatment Center between May 2008 and February 2010
Pre-assignment Details 33 participants recruited; 4 excluded (did not meet inclusion criteria based on evoked pain being less than moderate intensity during treadmill ambulation).
Arm/Group Title Pregabalin First, Diphenhydramine Second Diphenhydramine First, Pregabalin Second
Hide Arm/Group Description 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 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.
Period Title: First Intervention
Started 14 15
Completed 12 14
Not Completed 2 1
Reason Not Completed
Adverse Event             2             1
Period Title: Washout
Started 12 14
Completed 12 14
Not Completed 0 0
Period Title: Second Intervention
Started 12 14
Completed 12 14
Not Completed 0 0
Arm/Group Title All Study Participants
Hide Arm/Group Description

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

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
8
  27.6%
>=65 years
21
  72.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
69.76  (8.22)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
9
  31.0%
Male
20
  69.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Time to First Symptoms of Moderate Pain
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: minutes
2.52  (2.83) 3.06  (3.11)
2.Secondary Outcome
Title Final Pain as Measured by NRS
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
1.82  (.35) 1.53  (.35)
3.Secondary Outcome
Title Total Distance
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: meters
237.49  (27.47) 261.55  (27.47)
4.Secondary Outcome
Title Recovery Time
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: minutes
2.36  (.43) 3.15  (.43)
5.Secondary Outcome
Title Area Under the Curve
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale * minutes
100.59  (5.15) 95.26  (5.15)
6.Secondary Outcome
Title Visual Analog Scale (VAS)
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
52.31  (27.49) 46.31  (24.44)
7.Secondary Outcome
Title Oswestry Disability Index (ODI) Score
Hide Description 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.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
37.77  (2.76) 36.49  (2.76)
8.Secondary Outcome
Title Swiss Spinal Stenosis (SSS) Score- Symptom Severity
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
3.09  (.12) 2.94  (.12)
9.Secondary Outcome
Title Swiss Spinal Stenosis- Physical Function
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
2.40  (0.09) 2.94  (0.09)
10.Secondary Outcome
Title Modified Brief Pain Inventory (mBPI)- Interference Score
Hide Description 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).
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
3.70  (0.42) 3.58  (0.42)
11.Secondary Outcome
Title Roland Morris Disability Questionnaire
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
12.98  (.92) 11.48  (.92)
12.Secondary Outcome
Title Patient Global Assessment (PGA)
Hide Description 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 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome measures were obtained for all subjects as described in the Analysis Population Description of the primary outcome above.
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 26 26
Mean (Standard Error)
Unit of Measure: units on a scale
2.75  (.19) 2.83  (0.19)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pregabalin Diphenhydramine
Hide Arm/Group Description 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.
All-Cause Mortality
Pregabalin Diphenhydramine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pregabalin Diphenhydramine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/26 (0.00%)      0/26 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pregabalin Diphenhydramine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/26 (57.69%)      6/26 (23.08%)    
Gastrointestinal disorders     
Diarrhea   3/26 (11.54%)  3 2/26 (7.69%)  2
Nausea   1/26 (3.85%)  1 2/26 (7.69%)  2
General disorders     
Dizziness   9/26 (34.62%)  9 0/26 (0.00%)  0
Somnolence   5/26 (19.23%)  5 2/26 (7.69%)  2
Dry mouth   4/26 (15.38%)  4 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
Peripheral edema   5/26 (19.23%)  5 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: John Markman, MD
Organization: University of Rochester
Phone: 585-340-8926
Responsible Party: John Markman, University of Rochester
ClinicalTrials.gov Identifier: NCT00638443     History of Changes
Other Study ID Numbers: 16697
IIR#GA00818X ( Other Identifier: Sponsor ID )
First Submitted: March 12, 2008
First Posted: March 19, 2008
Results First Submitted: July 9, 2012
Results First Posted: June 20, 2016
Last Update Posted: June 20, 2016