Back Pain Without Radiation, Low Back Pain
Conditions
Keywords
ketorolac, diclofenac, ibuprofen, low back pain, back pain
Brief summary
Purpose: This is a randomized clinical trial comparing the effects of three different medications for acute low back pain (LBP):Ketorolac, Ibuprofen, Diclofenac Hypothesis: A daily regimen of ketorolac will provide greater relief of LBP than ibuprofen or diclofenac 5 days after an emergency department (ED) visit, as measured by the Roland Morris Disability Questionnaire (RMQ)
Detailed description
More than 2.5 million patients present to US emergency departments (ED) annually with low back pain. Up to half of ED patients with acute, new onset low back pain (LBP) report persistent moderate or severe pain one week after the ED visit. Non-steroidal anti-inflammatory drugs (NSAIDs) are an effective treatment of acute LBP, though their impact is only modest.Given the poor pain and functional outcomes that persist beyond an ED visit for acute LBP, this clinical trial proposes to determine whether there is a difference in efficacy between the NSAIDs ketorolac, ibuprofen, and diclofenac and for the treatment of acute, non-traumatic, non-radicular low back pain.
Interventions
DRUGKetorolac
Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
DRUGIbuprofen
Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
DRUGDiclofenac
Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
BEHAVIORALEducational 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
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Men or women age 18-64. * Present to ED primary for management of Low Back Pain (LBP) * Functionally impairing back pain: A baseline score of greater than 5 on the Roland-Morris Disability Questionnaire * Musculoskeletal etiology of low back. * Non-radicular pain. * Pain duration \<2 weeks (336 hours). * Non-traumatic LBP * Participant is to be discharged home.
Exclusion criteria
* Flank pain, that is pain originating from tissues lateral to the paraspinal muscles. * Not available for follow-up * Pregnant * Chronic pain syndrome * Allergic to or intolerant of investigational medications * Contra-indications to investigational medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 5 in Functional Impairment | Baseline to 5 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Worst LBP 2 Days After ED Visit | 2 days after Emergency department visit | 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. |
| Frequency of LBP 2 Days After ED Visit | 2 days after Emergency department visit | 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 |
| How Often Participants Used Assigned Medication | 24 hours to 5 days | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 66 |
| 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 (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 66 |
| 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 (available at http://www.niams.nih.gov/Health\_Info/Back\_Pain/default.asp) | 66 |
| Total | 198 |
Baseline characteristics
| Characteristic | Ketorolac + Educational Intervention | Ibuprofen + Educational Intervention | Diclofenac + Educational Intervention | Total |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 11.2 | 40.3 years STANDARD_DEVIATION 11.4 | 39.9 years STANDARD_DEVIATION 10.1 | 39.7 years STANDARD_DEVIATION 10.9 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 24 Participants | 25 Participants | 74 Participants |
| Sex: Female, Male Male | 41 Participants | 42 Participants | 41 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 3 / 66 | 16 / 66 | 6 / 66 |
| serious Total, serious adverse events | 0 / 66 | 1 / 66 | 0 / 66 |
Outcome results
Primary
Change From Baseline to Day 5 in Functional Impairment
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).
Time frame: Baseline to 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac + Educational Intervention | Change From Baseline to Day 5 in Functional Impairment | 11.9 score on a scale | Standard Deviation 8.8 |
| Ibuprofen + Educational Intervention | Change From Baseline to Day 5 in Functional Impairment | 9.4 score on a scale | Standard Deviation 9.5 |
| Diclofenac + Educational Intervention | Change From Baseline to Day 5 in Functional Impairment | 10.9 score on a scale | Standard Deviation 9.4 |
Secondary
Frequency of LBP 2 Days After ED Visit
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
Time frame: 2 days after Emergency department visit
Population: Participants with missing data not reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketorolac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Frequently | 5 Participants |
| Ketorolac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Sometimes | 26 Participants |
| Ketorolac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Rarely | 18 Participants |
| Ketorolac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Always | 6 Participants |
| Ketorolac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Never | 6 Participants |
| Ibuprofen + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Sometimes | 21 Participants |
| Ibuprofen + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Never | 7 Participants |
| Ibuprofen + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Rarely | 10 Participants |
| Ibuprofen + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Frequently | 9 Participants |
| Ibuprofen + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Always | 15 Participants |
| Diclofenac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Always | 11 Participants |
| Diclofenac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Frequently | 7 Participants |
| Diclofenac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Never | 10 Participants |
| Diclofenac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Sometimes | 21 Participants |
| Diclofenac + Educational Intervention | Frequency of LBP 2 Days After ED Visit | Rarely | 14 Participants |
Secondary
How Often Participants Used Assigned Medication
Time frame: 24 hours to 5 days
Population: Participants with missing data not reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketorolac + Educational Intervention | How Often Participants Used Assigned Medication | Once a day | 26 Participants |
| Ketorolac + Educational Intervention | How Often Participants Used Assigned Medication | Sometimes | 10 Participants |
| Ketorolac + Educational Intervention | How Often Participants Used Assigned Medication | Never | 2 Participants |
| Ketorolac + Educational Intervention | How Often Participants Used Assigned Medication | Only Once | 3 Participants |
| Ketorolac + Educational Intervention | How Often Participants Used Assigned Medication | Twice or more a day | 18 Participants |
| Ibuprofen + Educational Intervention | How Often Participants Used Assigned Medication | Sometimes | 4 Participants |
| Ibuprofen + Educational Intervention | How Often Participants Used Assigned Medication | Never | 1 Participants |
| Ibuprofen + Educational Intervention | How Often Participants Used Assigned Medication | Only Once | 5 Participants |
| Ibuprofen + Educational Intervention | How Often Participants Used Assigned Medication | Once a day | 18 Participants |
| Ibuprofen + Educational Intervention | How Often Participants Used Assigned Medication | Twice or more a day | 33 Participants |
| Diclofenac + Educational Intervention | How Often Participants Used Assigned Medication | Twice or more a day | 38 Participants |
| Diclofenac + Educational Intervention | How Often Participants Used Assigned Medication | Once a day | 15 Participants |
| Diclofenac + Educational Intervention | How Often Participants Used Assigned Medication | Never | 0 Participants |
| Diclofenac + Educational Intervention | How Often Participants Used Assigned Medication | Sometimes | 7 Participants |
| Diclofenac + Educational Intervention | How Often Participants Used Assigned Medication | Only Once | 3 Participants |
Secondary
Worst LBP 2 Days After ED Visit
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.
Time frame: 2 days after Emergency department visit
Population: Participants with missing data not reported.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ketorolac + Educational Intervention | Worst LBP 2 Days After ED Visit | None | 8 Participants |
| Ketorolac + Educational Intervention | Worst LBP 2 Days After ED Visit | Mild | 29 Participants |
| Ketorolac + Educational Intervention | Worst LBP 2 Days After ED Visit | Moderate | 18 Participants |
| Ketorolac + Educational Intervention | Worst LBP 2 Days After ED Visit | Severe | 6 Participants |
| Ibuprofen + Educational Intervention | Worst LBP 2 Days After ED Visit | Severe | 11 Participants |
| Ibuprofen + Educational Intervention | Worst LBP 2 Days After ED Visit | None | 10 Participants |
| Ibuprofen + Educational Intervention | Worst LBP 2 Days After ED Visit | Moderate | 23 Participants |
| Ibuprofen + Educational Intervention | Worst LBP 2 Days After ED Visit | Mild | 18 Participants |
| Diclofenac + Educational Intervention | Worst LBP 2 Days After ED Visit | Severe | 7 Participants |
| Diclofenac + Educational Intervention | Worst LBP 2 Days After ED Visit | Mild | 25 Participants |
| Diclofenac + Educational Intervention | Worst LBP 2 Days After ED Visit | Moderate | 18 Participants |
| Diclofenac + Educational Intervention | Worst LBP 2 Days After ED Visit | None | 13 Participants |