Trial · NCT02646124
Diazepam Use With Standard Management for Acute Low Back Pain
NCT02646124, Phase 2, Phase 3, Completed, Montefiore Medical Center; results first posted 2018-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Diazepam Use With Standard Management for Acute Low Back Pain. Trials, record NCT02646124. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02646124
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Diazepam Use With Standard Management for Acute Low Back Pain
- NCT number
- NCT02646124
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 114 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Low Back Pain
- Interventions
- Naproxen, Placebo, Diazepam
- First posted
- 2016-01-05
- Last updated
- 2018-08-01
- Results first posted
- 2018-07-03
Source ClinicalTrials.gov
Registered outcomes5
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 | Between baseline and one week after emergency department discharge | 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 With Moderate or Severe Pain, as Measured on an Ordinal Scale | 1 week after discharge from emergency department | Patients with moderate or serve pain. Worst Lower Back Pain (LBP) over the previous 24 hours, using a four point ordinal scale: severe, moderate, mild, or none. |
| Secondary | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours | One week after discharge from the emergency department | Telephone questionnaire is used to assess patients needing any analgesic or low back pain medication within the previous 24 hours. |
| Secondary | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours | Assessed three months after emergency department discharge | Patients needing any analgesic or LBP medication within the previous 72 hours |
| Secondary | Participants Satisfied With Treatment | 1 week | Participants who answered "Yes" when asked the question "Do you want to receive the same combination of medications during a subsequent visit to the ER?" |
Source ClinicalTrials.gov
Outcomes5
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 | Between baseline and one week after emergency department discharge | units on a scale | MEAN | |
| SECONDARY | Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | 1 week after discharge from emergency department | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours | One week after discharge from the emergency department | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 72 Hours | Assessed three months after emergency department discharge | data not collected | ||
| SECONDARY | Participants Satisfied With Treatment | 1 week | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
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 | Diazepam | 11 | 95% Confidence Interval 9 to 13 | units on a scale | |
| Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire | Placebo | 11 | 95% Confidence Interval 9 to 13 | units on a scale | |
| Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | Diazepam | 18 | Participants | ||
| Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | Placebo | 12 | Participants | ||
| Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours | Diazepam | 26 | Participants | ||
| Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours | Placebo | 25 | Participants | ||
| Participants Satisfied With Treatment | Diazepam | 44 | Participants | ||
| Participants Satisfied With Treatment | Placebo | 37 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diazepam | 57 | |
| Overall Study | STARTED | Placebo | 57 | |
| Overall Study | COMPLETED | Diazepam | 57 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | NOT COMPLETED | Diazepam | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 2 |
Source ClinicalTrials.gov
Adverse events8
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 | Drowsy | Nervous system disorders | Diazepam | 4 | 57 | 4 |
| other | Drowsy | Nervous system disorders | Placebo | 1 | 55 | 1 |
| other | Dizzy | Nervous system disorders | Diazepam | 1 | 57 | 1 |
| other | Dizzy | Nervous system disorders | Placebo | 0 | 55 | 0 |
| other | Stomach irritation | Gastrointestinal disorders | Diazepam | 1 | 57 | 1 |
| other | Stomach irritation | Gastrointestinal disorders | Placebo | 1 | 55 | 1 |
| other | Other | General disorders | Diazepam | 6 | 57 | 6 |
| other | Other | General disorders | Placebo | 6 | 55 | 6 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diazepam | 0 | 57 |
| Total, all-cause mortality | Placebo | 0 | 55 |
| Total, other adverse events | Diazepam | 12 | 57 |
| Total, other adverse events | Placebo | 8 | 55 |
| Total, serious adverse events | Diazepam | 0 | 57 |
| Total, serious adverse events | Placebo | 0 | 55 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Diazepam vs Placebo: Participants Satisfied With Treatment | Trial comparisons |
| Diazepam vs Placebo: Number of Participants With Moderate or Severe Pain, as Measured on an Ordinal Scale | Trial comparisons |
| Diazepam vs Placebo: Number of Participants Who Required Analgesic Medication for Low Back Pain Within the Previous 24 Hours | Trial comparisons |
| Diazepam vs Placebo: deaths from any cause | Trial comparisons |
| Diazepam vs Placebo: serious adverse events | Trial comparisons |
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/NCT02646124
GET https://conductscience.org/api/trials/v1/NCT02646124/registered