Trial · NCT03068897
Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
NCT03068897, Phase 4, Completed, Montefiore Medical Center; results first posted 2020-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain. Trials, record NCT03068897. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03068897
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain
- NCT number
- NCT03068897
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 320 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Low Back Pain
- Interventions
- Metaxalone, Tizanidine, Baclofen, Ibuprofen 600 mg, Educational intervention
- First posted
- 2017-03-03
- Last updated
- 2020-08-12
- Results first posted
- 2020-08-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Baseline and 7 days | 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. |
| Secondary | Number of Participants Who Experience Change in Low Back Pain | Baseline and 7 days | Change 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…..) |
| Secondary | Number of Participants With Need for Medication for Low Back Pain | 7 days | Patients will be asked what medications they have used for low back pain |
| Secondary | Levels of Disability | 7 days | Disability 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Baseline and 7 days | units on a scale | MEAN | |
| SECONDARY | Number of Participants Who Experience Change in Low Back Pain | Baseline and 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Need for Medication for Low Back Pain | 7 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Levels of Disability | 7 days | units on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Metaxalone | 10.1 | 95% Confidence Interval 8.0 to 12.3 | units on a scale | |
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Tizanidine | 11.2 | 95% Confidence Interval 9.2 to 13.2 | units on a scale | |
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Baclofen | 10.6 | 95% Confidence Interval 8.6 to 12.7 | units on a scale | |
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | Placebo | 11.1 | 95% Confidence Interval 9.0 to 13.3 | units on a scale | |
| Number of Participants Who Experience Change in Low Back Pain | Metaxalone | 28 | Participants | ||
| Number of Participants Who Experience Change in Low Back Pain | Tizanidine | 25 | Participants | ||
| Number of Participants Who Experience Change in Low Back Pain | Baclofen | 26 | Participants | ||
| Number of Participants Who Experience Change in Low Back Pain | Placebo | 22 | Participants | ||
| Number of Participants With Need for Medication for Low Back Pain | Metaxalone | 49 | Participants | ||
| Number of Participants With Need for Medication for Low Back Pain | Tizanidine | 48 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metaxalone | 80 | |
| Overall Study | STARTED | Tizanidine | 80 | |
| Overall Study | STARTED | Baclofen | 80 | |
| Overall Study | STARTED | Placebo | 80 | |
| Overall Study | COMPLETED | Metaxalone | 76 | |
| Overall Study | COMPLETED | Tizanidine | 76 | |
| Overall Study | COMPLETED | Baclofen | 79 | |
| Overall Study | COMPLETED | Placebo | 74 | |
| Overall Study | NOT COMPLETED | Metaxalone | 4 | |
| Overall Study | NOT COMPLETED | Tizanidine | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Drowsiness | Nervous system disorders | Metaxalone | 2 | 80 | 2 |
| other | Drowsiness | Nervous system disorders | Tizanidine | 3 | 80 | 3 |
| other | Drowsiness | Nervous system disorders | Baclofen | 4 | 80 | 4 |
| other | Drowsiness | Nervous system disorders | Placebo | 2 | 80 | 2 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Metaxalone | 3 | 80 | 3 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Tizanidine | 1 | 80 | 1 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Baclofen | 3 | 80 | 3 |
| other | Gastrointestinal complaint | Gastrointestinal disorders | Placebo | 2 | 80 | 2 |
| other | dizziness | Nervous system disorders | Metaxalone | 1 | 80 | 1 |
| other | dizziness | Nervous system disorders | Tizanidine | 2 | 80 | 2 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metaxalone | 0 | 80 |
| Total, all-cause mortality | Tizanidine | 0 | 80 |
| Total, all-cause mortality | Baclofen | 0 | 80 |
| Total, all-cause mortality | Placebo | 0 | 80 |
| Total, other adverse events | Metaxalone | 6 | 80 |
| Total, other adverse events | Tizanidine | 6 | 80 |
| Total, other adverse events | Baclofen | 7 | 80 |
| Total, other adverse events | Placebo | 5 | 80 |
| Total, serious adverse events | Metaxalone | 0 | 80 |
| Total, serious adverse events | Tizanidine | 0 | 80 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30955985 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03068897
GET https://conductscience.org/api/trials/v1/NCT03068897/registered