Trial Outcomes & Findings for PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin (NCT NCT02273908)
NCT ID: NCT02273908
Last Updated: 2021-02-03
Results Overview
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.
COMPLETED
331 participants
Baseline, Final Visit (Week 8)
2021-02-03
Participant Flow
The recruitment was conducted from Jun. 2014 to Dec. 2014 at 33 study sites.
Participant milestones
| Measure |
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
174
|
|
Overall Study
COMPLETED
|
124
|
169
|
|
Overall Study
NOT COMPLETED
|
33
|
5
|
Reasons for withdrawal
| Measure |
Pregabalin
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
|
|---|---|---|
|
Overall Study
Adverse Event
|
16
|
0
|
|
Overall Study
Lost to Follow-up
|
10
|
1
|
|
Overall Study
Did not meet entrance criteria
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
PROs in Chronic Low Back Pain Patients With Accompanying Lower Limb Pain (Neuropathic Component) Treated With Pregabalin
Baseline characteristics by cohort
| Measure |
Pregabalin
n=157 Participants
Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
|
Other Analgesics
n=174 Participants
Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
|
Total
n=331 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
114 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Age, Continuous
|
69.1 years
STANDARD_DEVIATION 14.12 • n=5 Participants
|
70.7 years
STANDARD_DEVIATION 12.17 • n=7 Participants
|
70.0 years
STANDARD_DEVIATION 13.13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
92 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
157 participants
n=5 Participants
|
174 participants
n=7 Participants
|
331 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Final Visit (Week 8)Population: Full Analysis Set; consisted of subjects who had at least one evaluable observation from any of the patient-reported outcomes, and only evaluable subjects who contributed to the particular outcome were evaluated in each analysis. 'n' signifies number of participants who were evaluable for specified categories at different time points
The Pain Related Sleep Interference Scale (past week recall) consists of an 11-point rating scale ranging from 0 (pain did not interfere with sleep) to 10 (pain completely interfered with sleep). Change the rating scale from baseline to week 8 in each group. Subjects are to describe how their pain has interfered with their sleep during the past week by choosing the appropriate number between 0 and 10.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=172 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Baseline (n=137,172)
|
3.1 scores on a scale
Standard Error 2.63
|
2.9 scores on a scale
Standard Error 2.40
|
|
Change From Baseline in Pain Related Sleep Interference Scale (PRSIS - Past Week Recall)
Change from baseline at Week 8 (n=115,160)
|
-1.306 scores on a scale
Standard Error 0.197
|
-0.357 scores on a scale
Standard Error 0.168
|
SECONDARY outcome
Timeframe: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=172 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
Baseline (n=137,172)
|
10.8 scores on a scale
Standard Error 5.20
|
9.1 scores on a scale
Standard Error 4.90
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
Change from baseline at Week 4(n=118,160)
|
-2.893 scores on a scale
Standard Error 0.312
|
-1.006 scores on a scale
Standard Error 0.270
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Total Score-
Change from baseline at Week 8 (n=115,160)
|
-3.670 scores on a scale
Standard Error 0.335
|
-1.411 scores on a scale
Standard Error 0.287
|
SECONDARY outcome
Timeframe: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The RMDQ is an index of how well patients with low back pain are able to function with regard to daily activities. The score for the index ranges from 0 to 24 with a lower score indicating better function.
Outcome measures
| Measure |
Pregabalin
n=113 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=138 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
Baseline (n=113,138)
|
39.77 scores on a scale
Standard Error 12.453
|
44.92 scores on a scale
Standard Error 9.845
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
Change from baseline at Week 4 (n=97,128)
|
5.1062 scores on a scale
Standard Error 0.6905
|
2.3772 scores on a scale
Standard Error 0.6039
|
|
Change From Baseline in Roland Morris Disability Questionnaire (RMDQ)-Japanese Standardized Score-
Change from baseline at Week 8 (n=99,127)
|
6.8377 scores on a scale
Standard Error 0.6833
|
3.5359 scores on a scale
Standard Error 0.6040
|
SECONDARY outcome
Timeframe: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The Pain NRS (past week recall) consists of an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain). Subjects are asked to describe their average pain during the past week by choosing the appropriate number between 0 and 10.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=172 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
Change from baseline at Week 8 (n=115,160)
|
-2.166 scores on a scale
Standard Error 0.181
|
-1.336 scores on a scale
Standard Error 0.155
|
|
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
Baseline (n=137,172)
|
6.2 scores on a scale
Standard Error 1.17
|
5.8 scores on a scale
Standard Error 1.14
|
|
Change From Baseline in Pain Numeric Rating Scale (Pain NRS - Past Week Recall)
Change from baseline at Week 4 (n=118,160)
|
1.763 scores on a scale
Standard Error 0.172
|
-1.089 scores on a scale
Standard Error 0.149
|
SECONDARY outcome
Timeframe: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. The Health State Profile is designed to record the subject's level of current health for five domains comprising a health profile: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Responses from the five domains are used to calculate a single utility index value.; 1 indicates better health state (no problems); 5 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile; from 11111 to 55555. Score is transformed and results in a total score range -0.025 to 1.000; higher score indicates a better health state.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=171 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
Baseline (n=137,171)
|
0.6647 units on a scale
Standard Error 0.1736
|
0.7233 units on a scale
Standard Error 0.1521
|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
Change from baseline at Week 4 (n=118,158)
|
0.0756 units on a scale
Standard Error 0.0103
|
0.0427 units on a scale
Standard Error 0.0089
|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-QOL-Score-
Change from baseline at Week 8 (n=114,159)
|
0.0804 units on a scale
Standard Error 0.0113
|
0.0600 units on a scale
Standard Error 0.0097
|
SECONDARY outcome
Timeframe: Baseline, Visit2 (Week4), Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The EQ-5D-5L is a copyrighted, subject-completed questionnaire designed to assess health-related quality of life in terms of a single index value or utility score. There are two components to the EQ-5D-5L: A Health State Profile and a Visual Analogue Scale (VAS). Recent guidance suggests that the Health State Profile and VAS should be administered together. The Visual Analogue Scale (VAS) is designed to rate the subject's current health state on a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=172 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
Baseline (n=137,172)
|
60.9 units on a scale
Standard Error 17.63
|
63.0 units on a scale
Standard Error 16.34
|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
Change from baseline at Week 4 (n=118,159)
|
2.633 units on a scale
Standard Error 1.373
|
1.341 units on a scale
Standard Error 1.185
|
|
Change From Baseline in Euro Qol 5-Dimensions (EQ-5D-5L)-Visual Analogue Scale -
Change from baseline at Week 8 (n=115,160)
|
6.970 units on a scale
Standard Error 1.602
|
2.272 units on a scale
Standard Error 1.364
|
SECONDARY outcome
Timeframe: Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The CGIC assessment includes one question (1-7 scale) inquiring about the subject's improvement considering their current disease state.; range from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=125 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=163 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
1.Very much improved
|
17 participants
|
3 participants
|
|
Clinical Global Impression of Change (CGIC)
2.Much improved
|
47 participants
|
24 participants
|
|
Clinical Global Impression of Change (CGIC)
3.Minimally improved
|
37 participants
|
47 participants
|
|
Clinical Global Impression of Change (CGIC)
4.No change
|
24 participants
|
79 participants
|
|
Clinical Global Impression of Change (CGIC)
5.Minimally worse
|
0 participants
|
9 participants
|
|
Clinical Global Impression of Change (CGIC)
6.Much worse
|
0 participants
|
1 participants
|
|
Clinical Global Impression of Change (CGIC)
7.Very much worse
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The PGIC is a subject-rated instrument that measures change in the subject's overall status on a 7-point scale. Scores range from 1 (very much improved) to 7 (very much worse).
Outcome measures
| Measure |
Pregabalin
n=117 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=161 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Patient Global Improvement of Change (PGIC)
7.Very much worse
|
0 participants
|
1 participants
|
|
Patient Global Improvement of Change (PGIC)
1.Very much improved
|
8 participants
|
5 participants
|
|
Patient Global Improvement of Change (PGIC)
2.Much improved
|
34 participants
|
22 participants
|
|
Patient Global Improvement of Change (PGIC)
3.Minimally improved
|
45 participants
|
44 participants
|
|
Patient Global Improvement of Change (PGIC)
4.No change
|
27 participants
|
71 participants
|
|
Patient Global Improvement of Change (PGIC)
5.Minimally worse
|
3 participants
|
17 participants
|
|
Patient Global Improvement of Change (PGIC)
6.Much worse
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Final Visit (Week8 or discontinuation)Population: Full Analysis Set
The WPAI: LBP is a self-administered questionnaire that measures the effect of general health and symptom severity on work productivity and regular activities. Subscale scores include Percent work time missed due to pain (PWP), Percent overall work impairment (PWI), Percent work productivity impairment due to pain (PWPI), Percent overall activity impairment (PAI). Each subscale score is expressed as an impairment percentage (0-100) where higher numbers indicate greater impairment and less productivity. Here, "n" signifies "Number of participants" for Baseline. In this study, the WPAI: LBP will measure the effect of the patient's Chronic Low Back Pain (CLBP) with accompanying lower limb pain (neuropathic component) on work productivity and regular activities.
Outcome measures
| Measure |
Pregabalin
n=137 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
n=172 Participants
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Work Productivity and Activity Impairment Scale (WPAI:LBP)
1.PWP (n=43, 56)
|
0.13 percentage of time missed
Standard Deviation 0.863
|
1.61 percentage of time missed
Standard Deviation 7.574
|
|
Work Productivity and Activity Impairment Scale (WPAI:LBP)
2.PWI (n=43, 55)
|
28.84 percentage of time missed
Standard Deviation 23.726
|
27.09 percentage of time missed
Standard Deviation 24.771
|
|
Work Productivity and Activity Impairment Scale (WPAI:LBP)
3.PWPI (n=43, 55)
|
28.88 percentage of time missed
Standard Deviation 23.797
|
27.84 percentage of time missed
Standard Deviation 25.814
|
|
Work Productivity and Activity Impairment Scale (WPAI:LBP)
4.PAI (n=42, 56)
|
31.19 percentage of time missed
Standard Deviation 26.152
|
29.64 percentage of time missed
Standard Deviation 23.039
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit2(week4),Final Visit(Week8 or discontinuation)Population: Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
Outcome measures
| Measure |
Pregabalin
n=157 Participants
Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
|
Other Analgesics
Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
|
|---|---|---|
|
Number of Patients With Adverse Events
|
56 participants of related AEs
|
—
|
Adverse Events
Pregabalin
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pregabalin
n=157 participants at risk
Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/157 • Number of events 2 • Baseline to Week 4, Week 8
Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
|
|
Nervous system disorders
Dizziness
|
10.8%
17/157 • Number of events 17 • Baseline to Week 4, Week 8
Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
|
|
Nervous system disorders
Headache
|
1.3%
2/157 • Number of events 2 • Baseline to Week 4, Week 8
Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
|
|
Nervous system disorders
Somnolence
|
13.4%
21/157 • Number of events 21 • Baseline to Week 4, Week 8
Safety Analysis Set; All subjects who received at least one dose of pregabalin. The primary objectives of this study did not include comparison of safety with usual care, consistent with the non-interventional nature of the study. Therefore, adverse events were not collected from the participants in usual care.
|
Additional Information
Study Director : Koichi Fujii, MD
Medical Affairs, Pfizer Japan Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place