Low Back Pain
Conditions
Brief summary
This is a randomized study, based in emergency departments, in which the investigators determine the utility of adding various skeletal muscle relaxants to standard therapy, which consists of ibuprofen and an educational session. Patients will be enrolled at the time of an emergency visit and followed for three months to determine outcomes.
Interventions
DRUGMetaxalone
Metaxalone 400-800mg
DRUGTizanidine
Tizanidine 2-4mg
DRUGBaclofen
Baclofen 10-20mg
DRUGIbuprofen 600 mg
Ibuprofen
BEHAVIORALEducational 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.
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Medications provided to patients are encapsulated. Medications vials are labelled with investigational stickers.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present to ED primary for management of LBP, defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. * Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP. * Patient is to be discharged home. Patients admitted to the hospital are more likely to be treated with parenteral medication and therefore are not appropriate for this study. * Age 18-64 Enrollment will be limited to adults younger than 65 years because of the increased risk of adverse medication effects in the elderly. * Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. * Pain duration \<2 weeks (336 hours). Patients with more than two weeks of pain are at increased risk of poor pain and functional outcomes.(9) * Prior to the acute attack of LBP, back pain cannot occur more frequently than once per month. Patients with more frequent back pain are at increased risk of poor pain and functional outcomes.(9) * Non-traumatic LBP: no substantial and direct trauma to the back within the previous month * Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire
Exclusion criteria
* Not available for follow-up * Pregnant or breast-feeding * Chronic pain syndrome defined as use of any analgesic medication on a daily or near-daily basis * Allergic to or intolerant of investigational medications * Contra-indications to non-steroidal anti-inflammatory drugs: 1) history of hypersensitivity to NSAIDs or aspirin 2) active or history of peptic ulcer disease, chronic dyspepsia, or active or history of gastrointestinal bleed 3) Severe heart failure (NYHA 2 or worse) 4) hypertension (JNC7 stage 2 or worse) 5) Chronic kidney disease 3 or worse 6) Current use of anti-coagulants 7) Hepatitis 8) Alcoholism * Contra-indications to muscle relaxants: 1) Concurrent use of centrally acting opioids; 2) Renal impairment; 3) Liver abnormality including cirrhosis or elevated enzymes 4) Use of any of the following medications: fluvoxamine, fluoroquinolones, amiodarone, mexiletine, propafenone, verapamil, cimetidine, famotidine, acyclovir, ticlopidine, oral contraceptive pills
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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…..) |
| 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 |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 80 |
| 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. | 80 |
| 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. | 80 |
| Total | 320 |
Baseline characteristics
| Characteristic | Metaxalone | Tizanidine | Baclofen | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 10 | 40 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 12 | 39 years STANDARD_DEVIATION 11 | 39 years STANDARD_DEVIATION 11 |
| Duration of low back pain in hours | 48 hours | 48 hours | 72 hours | 72 hours | 60 hours |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment United States | 80 participants | 80 participants | 80 participants | 80 participants | 320 participants |
| Sex: Female, Male Female | 36 Participants | 38 Participants | 23 Participants | 36 Participants | 133 Participants |
| Sex: Female, Male Male | 44 Participants | 42 Participants | 57 Participants | 44 Participants | 187 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 80 |
| other Total, other adverse events | 6 / 80 | 6 / 80 | 7 / 80 | 5 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 | 0 / 80 | 0 / 80 |
Outcome results
Primary
Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ)
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.
Time frame: Baseline and 7 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Metaxalone | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | 10.1 units on a scale |
| Tizanidine | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | 11.2 units on a scale |
| Baclofen | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | 10.6 units on a scale |
| Placebo | Change in Functional Impairment as Measured by the Roland Morris Disability Questionnaire (RMDQ) | 11.1 units on a scale |
Secondary
Levels of Disability
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.
Time frame: 7 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Metaxalone | Levels of Disability | 5 units on a scale |
| Tizanidine | Levels of Disability | 3 units on a scale |
| Baclofen | Levels of Disability | 6 units on a scale |
| Placebo | Levels of Disability | 3 units on a scale |
Secondary
Number of Participants Who Experience Change in Low Back Pain
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…..)
Time frame: Baseline and 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metaxalone | Number of Participants Who Experience Change in Low Back Pain | 28 Participants |
| Tizanidine | Number of Participants Who Experience Change in Low Back Pain | 25 Participants |
| Baclofen | Number of Participants Who Experience Change in Low Back Pain | 26 Participants |
| Placebo | Number of Participants Who Experience Change in Low Back Pain | 22 Participants |
Secondary
Number of Participants With Need for Medication for Low Back Pain
Patients will be asked what medications they have used for low back pain
Time frame: 7 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Metaxalone | Number of Participants With Need for Medication for Low Back Pain | 49 Participants |
| Tizanidine | Number of Participants With Need for Medication for Low Back Pain | 48 Participants |
| Baclofen | Number of Participants With Need for Medication for Low Back Pain | 49 Participants |
| Placebo | Number of Participants With Need for Medication for Low Back Pain | 46 Participants |