Trial Outcomes & Findings for Ibuprofen With or Without Acetaminophen for Low Back Pain (NCT NCT03554018)
NCT ID: NCT03554018
Last Updated: 2024-02-28
Results Overview
The Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
120 participants
Primary outcome timeframe
Baseline and one week after discharge from emergency department
Results posted on
2024-02-28
Participant Flow
Participant milestones
| Measure |
Ibuprofen and Acetaminophen
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
53
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
Ibuprofen and Acetaminophen
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ibuprofen and Acetaminophen
n=60 Participants
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
n=60 Participants
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41 years
STANDARD_DEVIATION 12 • n=60 Participants
|
41 years
STANDARD_DEVIATION 13 • n=60 Participants
|
41 years
STANDARD_DEVIATION 12 • n=120 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=60 Participants
|
28 Participants
n=60 Participants
|
57 Participants
n=120 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=60 Participants
|
32 Participants
n=60 Participants
|
63 Participants
n=120 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
120 participants
n=120 Participants
|
|
Duration of low back pain
|
48 hours
n=60 Participants
|
48 hours
n=60 Participants
|
48 hours
n=120 Participants
|
PRIMARY outcome
Timeframe: Baseline and one week after discharge from emergency departmentThe Roland Morris Disability Questionnaire (RMDQ) is a 24 item instrument that evaluates the impact of low back pain on one's daily life. It is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. Each question can be answered as either a "yes" or "no". The score ranges from 0 to 24 where a higher score reflects greater impairment and, therefore, worsening in the quality of life. The change in RMDQ is obtained by subtracting the RMDQ score at one week after discharge from the baseline score. The calculated mean and associated confidence interval values have been verified by staff statisticians.
Outcome measures
| Measure |
Ibuprofen and Acetaminophen
n=57 Participants
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
n=53 Participants
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire
|
11.1 units on a scale
Standard Deviation 10.7
|
11.9 units on a scale
Standard Deviation 9.7
|
SECONDARY outcome
Timeframe: 7 days after discharge from emergency departmentData collected by telephone questionnaire. Participants asked to assess intensity of low back pain over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Outcome measures
| Measure |
Ibuprofen and Acetaminophen
n=57 Participants
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
n=53 Participants
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 7 days after discharge from emergency departmentPopulation: Data was collected and analyzed for 52 participants in the "Ibuprofen and Placebo" group.
Telephone questionnaire is used to assess number of patients needing any analgesic or low back pain medication within the previous 24 hours.
Outcome measures
| Measure |
Ibuprofen and Acetaminophen
n=57 Participants
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
n=52 Participants
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours.
|
36 Participants
|
32 Participants
|
Adverse Events
Ibuprofen and Acetaminophen
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Ibuprofen and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ibuprofen and Acetaminophen
n=60 participants at risk
Acetaminophen 500-1000mg every 6 hours for 7 days Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Acetaminophen: Acetaminophen 500-1000mg every 6 hours
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
|
Ibuprofen and Placebo
n=60 participants at risk
Placebo Participants in this arm will also receive ibuprofen 600mg every 6 hours for 7 days and an educational intervention.
Ibuprofen 600 mg: Ibuprofen 600mg every 6 hours
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp)
Placebo oral capsule: To match acetaminophen, patients will take one or two capsules every 6 hours
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
3/60 • 48 hours
|
1.7%
1/60 • 48 hours
|
|
Nervous system disorders
Drowsiness
|
3.3%
2/60 • 48 hours
|
1.7%
1/60 • 48 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place