Trial Outcomes & Findings for Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain (NCT NCT03068897)
NCT ID: NCT03068897
Last Updated: 2020-08-12
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
320 participants
Primary outcome timeframe
Baseline and 7 days
Results posted on
2020-08-12
Participant Flow
Participant milestones
| Measure |
Metaxalone
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
80
|
80
|
80
|
|
Overall Study
COMPLETED
|
76
|
76
|
79
|
74
|
|
Overall Study
NOT COMPLETED
|
4
|
4
|
1
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Metaxalone
n=80 Participants
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=80 Participants
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=80 Participants
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=80 Participants
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
37 years
STANDARD_DEVIATION 10 • n=80 Participants
|
40 years
STANDARD_DEVIATION 11 • n=80 Participants
|
39 years
STANDARD_DEVIATION 12 • n=80 Participants
|
39 years
STANDARD_DEVIATION 11 • n=80 Participants
|
39 years
STANDARD_DEVIATION 11 • n=320 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=80 Participants
|
38 Participants
n=80 Participants
|
23 Participants
n=80 Participants
|
36 Participants
n=80 Participants
|
133 Participants
n=320 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=80 Participants
|
42 Participants
n=80 Participants
|
57 Participants
n=80 Participants
|
44 Participants
n=80 Participants
|
187 Participants
n=320 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
80 participants
n=80 Participants
|
80 participants
n=80 Participants
|
80 participants
n=80 Participants
|
80 participants
n=80 Participants
|
320 participants
n=320 Participants
|
|
Duration of low back pain in hours
|
48 hours
n=80 Participants
|
48 hours
n=80 Participants
|
72 hours
n=80 Participants
|
72 hours
n=80 Participants
|
60 hours
n=320 Participants
|
PRIMARY outcome
Timeframe: Baseline and 7 daysThe 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.
Outcome measures
| Measure |
Metaxalone
n=76 Participants
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=76 Participants
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=79 Participants
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=74 Participants
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
|
10.1 units on a scale
Interval 8.0 to 12.3
|
11.2 units on a scale
Interval 9.2 to 13.2
|
10.6 units on a scale
Interval 8.6 to 12.7
|
11.1 units on a scale
Interval 9.0 to 13.3
|
SECONDARY outcome
Timeframe: Baseline and 7 daysChange is assessed by verbal numerical scale of which 0 represents no pain and 10 represents the worst pain imaginable between the baseline ED visit and the one week follow-up (baseline - 1 week ). The baseline questions will refer to the time period immediately prior to ED presentation (Before you came to the ER today, were you able to…..)
Outcome measures
| Measure |
Metaxalone
n=76 Participants
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=76 Participants
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=79 Participants
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=73 Participants
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Number of Participants Who Experience Change in Low Back Pain
|
28 Participants
|
25 Participants
|
26 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: 7 daysPatients will be asked what medications they have used for low back pain
Outcome measures
| Measure |
Metaxalone
n=76 Participants
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=76 Participants
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=79 Participants
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=73 Participants
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Number of Participants With Need for Medication for Low Back Pain
|
49 Participants
|
48 Participants
|
49 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 7 daysDisability will be assessed with the Roland-Morris Disability Questionnaire (RMDQ) where patients are asked to tick a box if they agree with 24 statements regarding their ability to perform certain activities (dressing, housework, walking). If the don't agree with the statement (able to perform those activities) they need to leave the tick-box blank or unchecked. Every agreement (tick) counts as a point and an absolute value is formed (min: 0, max: 24). The higher the value the higher the disability level.
Outcome measures
| Measure |
Metaxalone
n=76 Participants
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=76 Participants
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=79 Participants
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=74 Participants
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Levels of Disability
|
5 units on a scale
Interval 0.0 to 16.0
|
3 units on a scale
Interval 0.0 to 15.0
|
6 units on a scale
Interval 0.0 to 16.0
|
3 units on a scale
Interval 0.0 to 15.0
|
Adverse Events
Metaxalone
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Tizanidine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Baclofen
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Metaxalone
n=80 participants at risk
Ibuprofen 600mg mg + metaxalone 400-800mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Metaxalone: Metaxalone 400-800mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Tizanidine
n=80 participants at risk
Ibuprofen 600mg mg + tizanidine 2-4mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Tizanidine: Tizanidine 2-4mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Baclofen
n=80 participants at risk
Ibuprofen 600mg mg + baclofen 10-20 mg every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Baclofen: Baclofen 10-20mg
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
Placebo
n=80 participants at risk
Ibuprofen 600mg mg + placebo, 1 or 2 capsules, every 8 hours, as needed for low back pain, x 7 days.
All participants receive a brief educational intervention.
Ibuprofen 600 mg: Ibuprofen
Educational intervention: Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
|
|---|---|---|---|---|
|
Nervous system disorders
Drowsiness
|
2.5%
2/80 • Number of events 2 • 7 days
|
3.8%
3/80 • Number of events 3 • 7 days
|
5.0%
4/80 • Number of events 4 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
|
Gastrointestinal disorders
Gastrointestinal complaint
|
3.8%
3/80 • Number of events 3 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
3.8%
3/80 • Number of events 3 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
|
Nervous system disorders
dizziness
|
1.2%
1/80 • Number of events 1 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
2.5%
2/80 • Number of events 2 • 7 days
|
0.00%
0/80 • 7 days
|
|
General disorders
urinary complaint
|
0.00%
0/80 • 7 days
|
0.00%
0/80 • 7 days
|
0.00%
0/80 • 7 days
|
1.2%
1/80 • Number of events 1 • 7 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place