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This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral ibuprofen + topical diclofenac | Experimental | Oral ibuprofen 400mg Topical diclofenac 4gm |
|
| Oral ibuprofen + topical placebo | Active Comparator | Oral ibuprofen 400mg Topical placebo |
|
| Oral placebo + topical diclofenac | Active Comparator | Oral placebo Topical diclofenac 4gm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg | Drug | Ibuprofen 400mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability). | Baseline to 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Worst Low Back Pain (LBP) | Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore | New York | New York | 10026 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38441515 | Derived | Khankhel N, Friedman BW, Baer J, Lopez L, Feliciano C, Lee S, Irizarry E. Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study. Ann Emerg Med. 2024 Jun;83(6):542-551. doi: 10.1016/j.annemergmed.2024.01.037. Epub 2024 Mar 2. |
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In total, 3281 patients were screened for participation and 198 were randomized into the study. 1 patient was excluded post-randomization due to missing RMDQ data.
Enrollment commenced in March 2021 and concluded in June 2023. The study was conducted in 2 Emergency Departments (EDs) both affiliated with Montefiore Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Ibuprofen + Topical Diclofenac | Oral ibuprofen 400mg Topical diclofenac 4gm Ibuprofen 400 mg: Ibuprofen 400mg Topical diclofenac: Diclofenac 1% gel 4gm |
| FG001 | Oral Ibuprofen + Topical Placebo | Oral ibuprofen 400mg Topical placebo Ibuprofen 400 mg: Ibuprofen 400mg |
| FG002 | Oral Placebo + Topical Diclofenac | Oral placebo Topical diclofenac 4gm Topical diclofenac: Diclofenac 1% gel 4gm |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2-day Follow up |
|
| ||||||||||||||||||
| 7-day Follow up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Ibuprofen + Topical Diclofenac | Oral ibuprofen 400mg Topical diclofenac 4gm Ibuprofen 400 mg: Ibuprofen 400mg Topical diclofenac: Diclofenac 1% gel 4gm |
| BG001 | Oral Ibuprofen + Topical Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report 'Yes/no' instrument about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 2-day (48 hour) follow-up' with positive scores being indicative of improvement (less pain disability). | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up (LTFU) prior to the 48 hour assessment timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline to 48 hours |
|
From baseline up to 7 days following treatment
Medication-related adverse events were elicited by asking whether the study medications caused any new symptoms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Ibuprofen + Topical Diclofenac | Oral ibuprofen 400mg Topical diclofenac 4gm Ibuprofen 400 mg: Ibuprofen 400mg Topical diclofenac: Diclofenac 1% gel 4gm |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2020 | Aug 5, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 8, 2022 | Aug 5, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D004008 | Diclofenac |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Topical diclofenac | Drug | Diclofenac 1% gel 4gm |
|
| Use of Medication for Low Back Pain (LBP) | Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized. | 48 hours |
| Frequency of Low Back Pain (LBP) | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. | 48 hours |
| Return to Usual Activities | The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group. | 48 hours |
| Number of Visits to Any Healthcare Provider | The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group. | 48 hours |
| Treatment Satisfaction | Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group. | 48 hours |
| Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability). | 7 days |
| Worst Low Back Pain (LBP) | Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized. | 7 days |
| Use of Medication for Low Back Pain (LBP) | Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized. | 7 days |
| Frequency of Low Back Pain | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. | 7 days |
| Return to Usual Activities | The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group. | 7 days |
| Number of Visits to Any Healthcare Provider | The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group. | 7 days |
| Treatment Satisfaction | Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group. | 7 days |
| NOT COMPLETED |
|
Oral ibuprofen 400mg Topical placebo
Ibuprofen 400 mg: Ibuprofen 400mg
| BG002 | Oral Placebo + Topical Diclofenac | Oral placebo Topical diclofenac 4gm Topical diclofenac: Diclofenac 1% gel 4gm |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity data was aggregated for this study. 1 participant in the 'Oral Ibuprofen + Topical Diclofenac' arm, 3 participants in the 'Oral Ibuprofen + Topical Placebo' arm, and 2 participants in the 'Oral Placebo + Topical Diclofenac' arm refused to provide demographic data. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Roland-Morris Disability Questionnaire (RMDQ) at ED visit | The RMDQ is a 24-item patient-reported outcome measure that assesses the level of disability caused by low back pain (LBP). The RMDQ is scored by adding up the number of items the patient checks or answers with "yes". Each item is worth one point, and the score ranges from 0 to 24, with higher scores indicating greater LBP disability | Median | Inter-Quartile Range | score on a scale |
|
| Duration of Low Back Pain before presentation to ED | Median | Inter-Quartile Range | hours |
|
| Patients with Previous Episodes of Low Back Pain | Count of Participants | Participants |
|
Oral ibuprofen 400mg Topical diclofenac 4gm Ibuprofen 400 mg: Ibuprofen 400mg Topical diclofenac: Diclofenac 1% gel 4gm |
| OG001 | Oral Ibuprofen + Topical Placebo | Oral ibuprofen 400mg Topical placebo Ibuprofen 400 mg: Ibuprofen 400mg |
| OG002 | Oral Placebo + Topical Diclofenac | Oral placebo Topical diclofenac 4gm Topical diclofenac: Diclofenac 1% gel 4gm |
|
|
| Secondary | Worst Low Back Pain (LBP) | Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized. | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Use of Medication for Low Back Pain (LBP) | Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized. | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were LTFU prior to 48 hour assessment timepoints; however, data was able to be collected from 3 LTFU participants in the Ibuprofen + Diclofenac group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group. | Posted | Count of Participants | Participants | 48 hours |
|
|
|
| Secondary | Frequency of Low Back Pain (LBP) | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. | Data regarding Frequency of Low Back Pain was not collected. | Posted | 48 hours |
|
|
| Secondary | Return to Usual Activities | The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group. | Data related to the percentage of patients who were able to return to usual activities was not collected. | Posted | 48 hours |
|
|
| Secondary | Number of Visits to Any Healthcare Provider | The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group. | Data related to the number of visits to any healthcare provider was not collected. | Posted | 48 hours |
|
|
| Secondary | Treatment Satisfaction | Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group. | Data related to treatment satisfaction was not collected. | Posted | 48 hours |
|
|
| Secondary | Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score | Change in Pain Disability was assessed using the Roland-Morris Disability Questionnaire (RMDQ). The RMDQ is a 24-item self-report questionnaire about how low-back pain affects functional activities. Each question is worth one point so scores can range from 0 (no disability) to 24 (severe disability). Change in RMDQ was measured by calculating: 'Baseline RMDQ score - RMDQ Score at 7-day follow-up with positive scores being indicative of improvement (less pain disability). | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo + topical diclofenac' group were lost to follow-up prior to the 7-day assessment timepoints. | Posted | Mean | 95% Confidence Interval | score on a scale | 7 days |
|
|
|
| Secondary | Worst Low Back Pain (LBP) | Worst low back was evaluated by asking patients "How would you describe your worst low back pain in the last 24 hours?" Patients were asked to describe their worst LBP using the terms "Severe", "Moderate", "Mild", or "None". Counts of participants reporting each degree of severity over the prior 24 hours are summarized. | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group. Data was also not collected from 1 other participant in the 'Diclofenac + Placebo' group. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Use of Medication for Low Back Pain (LBP) | Participants were asked "During the last 24 hours, have you taken any medication at all for low back pain?" and asked to respond either "Yes" or "No". Counts of participants using medication during the prior 24 hours are summarized. | 5 participants in the 'Oral ibuprofen + topical diclofenac' group; 6 participants in the 'Oral ibuprofen + topical placebo' group; and 3 participants in the 'Oral placebo and topical diclofenac' group were lost to follow-up prior to the 7 day assessment timepoints; however data was able to be collected from 1 of the LTFU participants in the 'Ibuprofen + Diclofenac' group. | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Frequency of Low Back Pain | Frequency of Low Back Pain will be evaluated by asking patients "Over the last 24 hours, how often were you in pain?" Patients will be asked to respond to the frequency of their LBP over the prior 24 hours based on a 5-point Likert scale consisting of "Not at all", "Rarely", "Sometimes", "Usually", or "Always". This question will help determine the burdensomeness of the LBP in the patient's daily life. Counts of participants reporting each frequency will be summarized. | Data regarding Frequency of Low Back Pain was not collected. | Posted | 7 days |
|
|
| Secondary | Return to Usual Activities | The percentage of patients who were able to return to usual activities following treatment will be quantified by asking patients to provide a binary "Yes" or "No" response to a question of whether they were able to return to day-to-day activities. Results will be summarized by treatment group. | Data related to the percentage of patients who were able to return to usual activities was not collected. | Posted | 7 days |
|
|
| Secondary | Number of Visits to Any Healthcare Provider | The number of visits to any healthcare provider will be determined by asking patients whether they had any planned or emergent inpatient or outpatient visits to any healthcare provider for any reason during the course of the study. Group mean results will be summarized by treatment group. | Data related to the number of visits to any healthcare provider was not collected. | Posted | 7 days |
|
|
| Secondary | Treatment Satisfaction | Patient satisfaction with the treatment they received will be assessed by their response to a binary "Yes" or "No" question regarding satisfaction with their treatment. Results will be summarized by treatment group. | Data related to treatment satisfaction was not collected. | Posted | 7 days |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 4 |
| 60 |
| EG001 | Oral Ibuprofen + Topical Placebo | Oral ibuprofen 400mg Topical placebo Ibuprofen 400 mg: Ibuprofen 400mg | 0 | 60 | 0 | 60 | 3 | 60 |
| EG002 | Oral Placebo + Topical Diclofenac | Oral placebo Topical diclofenac 4gm Topical diclofenac: Diclofenac 1% gel 4gm | 0 | 63 | 0 | 63 | 1 | 63 |
| Pruritis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Muscle Cramp | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D010648 |
| Phenylacetates |
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Moderate |
|
| Severe |
|
| Title | Measurements |
|---|---|
|