Low Back Pain
Conditions
Brief summary
Low back pain is a common cause of visit to emergency department. It is not clear if skeletal muscle relaxants are of benefit for patients with acute low back pain. This is a randomized study to determine if skeletal muscle relaxants, when combined with naproxen, improve outcomes more than naproxen alone
Detailed description
Patients with acute, non-traumatic, non-radicular low back pain will be enrolled at the time of discharge from the emergency department. Participants will be followed by telephone one week and 3 months after the ED visit
Interventions
DRUGOrphenadrine
Orphenadrine 100mg PO BID x 7 days
DRUGMethocarbamol
Methocarbamol 750mg 1-2 tabs po TID x 7 days
DRUGNaproxen
Naproxen 500mg PO BID x 7 days
DRUGPlacebo
1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* LBP duration \<= 2 weeks * No trauma to low back within previous month * No radicular symptoms * No history of low back pain or history of only infrequent episodes
Exclusion criteria
* Medication allergies or contra-indications * Not available for follow-up * Chronic pain syndrome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Impairment as Measured on the Roland Morris Disability Questionnaire | 1 week | Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cases of Moderate or Severe LBP | 1 week | Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none |
| Medications--Patient Self Report of Medication Use | 1 week | Participants still using medication such as analgesics for LBP after treatment |
| Patient Satisfaction With Treatment | 1 week | The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Naproxen 500mg po BID x 10 days #20 + Placebo
Naproxen: Naproxen 500mg PO BID x 7 days
Placebo: 1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days | 79 |
| Orphenadrine Naproxen 500mg po BID x 10 days #20 + Orphenadrine
Orphenadrine: Orphenadrine 100mg PO BID x 7 days
Naproxen: Naproxen 500mg PO BID x 7 days | 80 |
| Methocarbamol Naproxen 500mg po BID x 10 days #20 + Methocarbamol
Methocarbamol: Methocarbamol 750mg 1-2 tabs po TID x 7 days
Naproxen: Naproxen 500mg PO BID x 7 days | 81 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 1 |
Baseline characteristics
| Characteristic | Placebo | Orphenadrine | Methocarbamol | Total |
|---|---|---|---|---|
| Age, Continuous | 39 years STANDARD_DEVIATION 12 | 40 years STANDARD_DEVIATION 12 | 38 years STANDARD_DEVIATION 12 | 39 years STANDARD_DEVIATION 12 |
| Duration of Back Pain Prior to Study | 48 Hours | 72 Hours | 48 Hours | 48 Hours |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment United States | 79 Participants | 80 Participants | 81 Participants | 240 Participants |
| Sex: Female, Male Female | 34 Participants | 34 Participants | 41 Participants | 109 Participants |
| Sex: Female, Male Male | 45 Participants | 46 Participants | 40 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 78 | 0 / 80 |
| other Total, other adverse events | 9 / 76 | 8 / 78 | 14 / 80 |
| serious Total, serious adverse events | 0 / 76 | 0 / 78 | 0 / 80 |
Outcome results
Primary
Functional Impairment as Measured on the Roland Morris Disability Questionnaire
Change in Roland Morris Disability Questionnaire between baseline and 1 week. The low back pain functional disability scale is the RMDQ. The RMDQ is a 24-item low back pain functional scale recommended for use in low back pain research.Higher scores signify greater low back-related functional impairment.0= no functional impairment, 24= severe functional impairment.
Time frame: 1 week
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Functional Impairment as Measured on the Roland Morris Disability Questionnaire | 10.9 units on a scale |
| Orphenadrine | Functional Impairment as Measured on the Roland Morris Disability Questionnaire | 9.4 units on a scale |
| Methocarbamol | Functional Impairment as Measured on the Roland Morris Disability Questionnaire | 8.1 units on a scale |
Secondary
Cases of Moderate or Severe LBP
Participants with moderate to severe low back pain after treatment as report on the following ordinal scale: severe, moderate, mild, or none
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Cases of Moderate or Severe LBP | 34 Participants |
| Orphenadrine | Cases of Moderate or Severe LBP | 26 Participants |
| Methocarbamol | Cases of Moderate or Severe LBP | 31 Participants |
Secondary
Medications--Patient Self Report of Medication Use
Participants still using medication such as analgesics for LBP after treatment
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Medications--Patient Self Report of Medication Use | 42 Participants |
| Orphenadrine | Medications--Patient Self Report of Medication Use | 40 Participants |
| Methocarbamol | Medications--Patient Self Report of Medication Use | 50 Participants |
Secondary
Patient Satisfaction With Treatment
The number of participants with affirmative response to the following question: Do you want the same medication combination during a subsequent episode of LBP. This is a patient-centered outcome that allows each individual to determine the desirability of the intervention.
Time frame: 1 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Patient Satisfaction With Treatment | 51 Participants |
| Orphenadrine | Patient Satisfaction With Treatment | 53 Participants |
| Methocarbamol | Patient Satisfaction With Treatment | 51 Participants |