Trial Outcomes & Findings for Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial (NCT NCT02013427)
NCT ID: NCT02013427
Last Updated: 2023-03-03
Results Overview
The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain). Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
82 participants
Primary outcome timeframe
6 weeks
Results posted on
2023-03-03
Participant Flow
Participant milestones
| Measure |
Observational
Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.
|
Naproxen & Omeprazole
Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Naproxen: Take one 500mg naproxen capsule twice a day.
Omeprazole: Take one 20mg omeprazole capsule twice a day.
|
Placebo Only
Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Placebo: Take one placebo capsule twice a day.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
5
|
52
|
|
Overall Study
COMPLETED
|
20
|
4
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Placebo In Chronic Back Pain - Double-Blind Randomized Control Trial
Baseline characteristics by cohort
| Measure |
Observational- NoTx
n=25 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.
|
PTx (Placebo)
n=52 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo pills (lactose) capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Placebo: Take two placebo capsules twice a day.
|
MTx (Naproxen + Omeprazol)
n=5 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Naproxen: Take one 500mg naproxen capsule twice a day. Omeprazole: Take one 20mg omeprazole capsule twice a day.
|
Total
n=82 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
81 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 13.0 • n=99 Participants
|
46.6 years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
53.8 years
STANDARD_DEVIATION 5.1 • n=206 Participants
|
47.3 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
32 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
50 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=99 Participants
|
52 participants
n=107 Participants
|
5 participants
n=206 Participants
|
82 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: 67 patients were randomized into an Observational arm (no treatment, n = 20), Naproxen \& Omeprazole (active treatment, n=4) and Placebo only (placebo, n = 43).
The primary outcome was changes (% change) in self-reported pain levels using VAS - from 0 (no pain) to 10 (worst imaginable pain). Results are presented as largest percentage (%) change in pain before and after the interventions (baseline and post-intervention, 6 weeks). Percentage change is calculated with post-intervention pain minus baseline pain, divided by baseline pain i.e. (post - baseline) / baseline.
Outcome measures
| Measure |
Observational
n=20 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications for the length of the study. This arm is not blinded, as both study staff and participants will be aware that they are not receiving a study treatment.
|
Naproxen & Omeprazole
n=4 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications and take one 500mg naproxen capsule and one 40mg omeprazole capsule twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Naproxen: Take one 500mg naproxen capsule twice a day.
Omeprazole: Take one 20mg omeprazole capsule twice a day.
|
Placebo Only
n=43 Participants
Subjects randomized to this arm will be asked to discontinue their current pain medications and take two placebo capsules twice a day for the length of the study. This arm is double-blind, as neither participants nor study staff will know what medication the participants is receiving (blind to active versus placebo treatment).
Placebo: Take one placebo capsule twice a day.
|
|---|---|---|---|
|
Change in Pain Assessed by Visual Analogue Scale (VAS)
|
-0.03 percentage of change in pain
Standard Deviation 0.14
|
-0.10 percentage of change in pain
Standard Deviation 0.09
|
-0.21 percentage of change in pain
Standard Deviation 0.21
|
Adverse Events
Observational- NoTx
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PTx (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
MTx (Naproxen & Omeprazole)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place