Trial Outcomes & Findings for A Comparison of NSAIDs for Acute, Non-radicular Low Back Pain. (NCT NCT03861611)
NCT ID: NCT03861611
Last Updated: 2022-05-31
Results Overview
The change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
198 participants
Primary outcome timeframe
Baseline to 5 days
Results posted on
2022-05-31
Participant Flow
Participant milestones
| Measure |
Ketorolac + Educational Intervention
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage
|
Ibuprofen + Educational Intervention
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage
|
Diclofenac + Educational Intervention
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on National Institute of Arthritis and Musculoskeletal and Skin Diseases Handout on Health: Back Pain information webpage
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
59
|
61
|
62
|
|
Overall Study
NOT COMPLETED
|
7
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ketorolac + Educational Intervention
n=66 Participants
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=66 Participants
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=66 Participants
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39 years
STANDARD_DEVIATION 11.2 • n=66 Participants
|
40.3 years
STANDARD_DEVIATION 11.4 • n=66 Participants
|
39.9 years
STANDARD_DEVIATION 10.1 • n=66 Participants
|
39.7 years
STANDARD_DEVIATION 10.9 • n=198 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=66 Participants
|
24 Participants
n=66 Participants
|
25 Participants
n=66 Participants
|
74 Participants
n=198 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=66 Participants
|
42 Participants
n=66 Participants
|
41 Participants
n=66 Participants
|
124 Participants
n=198 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline to 5 daysThe change will be assessed by Roland Morris Disability Questionnaire between the baseline ED visit and the five day follow-up. The Roland-Morris Questionnaire (RMQ) is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale (0-24).
Outcome measures
| Measure |
Ketorolac + Educational Intervention
n=59 Participants
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=61 Participants
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=62 Participants
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
Change From Baseline to Day 5 in Functional Impairment
|
11.9 score on a scale
Standard Deviation 8.8
|
9.4 score on a scale
Standard Deviation 9.5
|
10.9 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 2 days after Emergency department visitPopulation: Participants with missing data not reported.
Participants were called 2 days after ED visit and asked to report their worst LBP experienced over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none.
Outcome measures
| Measure |
Ketorolac + Educational Intervention
n=61 Participants
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=62 Participants
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=63 Participants
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
Worst LBP 2 Days After ED Visit
None
|
8 Participants
|
10 Participants
|
13 Participants
|
|
Worst LBP 2 Days After ED Visit
Mild
|
29 Participants
|
18 Participants
|
25 Participants
|
|
Worst LBP 2 Days After ED Visit
Moderate
|
18 Participants
|
23 Participants
|
18 Participants
|
|
Worst LBP 2 Days After ED Visit
Severe
|
6 Participants
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 2 days after Emergency department visitPopulation: Participants with missing data not reported.
Participants were called 2 days after ED visit and asked to report the frequency of LBP experienced over the previous 24 hours. Frequency was assessed using the five point Likert scale: Not at all, Rarely, Sometimes, Usually, Always
Outcome measures
| Measure |
Ketorolac + Educational Intervention
n=61 Participants
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=62 Participants
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=63 Participants
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
Frequency of LBP 2 Days After ED Visit
Never
|
6 Participants
|
7 Participants
|
10 Participants
|
|
Frequency of LBP 2 Days After ED Visit
Rarely
|
18 Participants
|
10 Participants
|
14 Participants
|
|
Frequency of LBP 2 Days After ED Visit
Sometimes
|
26 Participants
|
21 Participants
|
21 Participants
|
|
Frequency of LBP 2 Days After ED Visit
Frequently
|
5 Participants
|
9 Participants
|
7 Participants
|
|
Frequency of LBP 2 Days After ED Visit
Always
|
6 Participants
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 24 hours to 5 daysPopulation: Participants with missing data not reported.
Outcome measures
| Measure |
Ketorolac + Educational Intervention
n=59 Participants
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=61 Participants
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=63 Participants
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
How Often Participants Used Assigned Medication
Never
|
2 Participants
|
1 Participants
|
0 Participants
|
|
How Often Participants Used Assigned Medication
Only Once
|
3 Participants
|
5 Participants
|
3 Participants
|
|
How Often Participants Used Assigned Medication
Sometimes
|
10 Participants
|
4 Participants
|
7 Participants
|
|
How Often Participants Used Assigned Medication
Once a day
|
26 Participants
|
18 Participants
|
15 Participants
|
|
How Often Participants Used Assigned Medication
Twice or more a day
|
18 Participants
|
33 Participants
|
38 Participants
|
Adverse Events
Ketorolac + Educational Intervention
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ibuprofen + Educational Intervention
Serious events: 1 serious events
Other events: 16 other events
Deaths: 0 deaths
Diclofenac + Educational Intervention
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ketorolac + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/66 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
1.5%
1/66 • Number of events 1 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
0.00%
0/66 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
Other adverse events
| Measure |
Ketorolac + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive Ketorolac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ketorolac: Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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 + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive Ibuprofen for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Ibuprofen: Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
Diclofenac + Educational Intervention
n=66 participants at risk
Participants may be randomized to receive diclofenac for their LBP. Research personnel will provide each participant with a 15-minute educational intervention.
Diclofenac: Participants may be randomized to receive Diclofenac oral medication 50 mg, every 8 hours for 5 days as needed
Educational Intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on 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)
|
|---|---|---|---|
|
Gastrointestinal disorders
Stomach irritation
|
4.5%
3/66 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
24.2%
16/66 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
9.1%
6/66 • 5 days
Study participants were asked: Did you have any side effects from the medications you've been taking for low back pain? Study participants were also asked: Did the medication irritate your stomach? 1 patient randomized to ibuprofen was admitted to the hospital for angioedema which was may have been due to concomitant angiotensin converting enzyme inhibitor use.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place