SGEM#173: Diazepam Won’t Get Back Pain Down

Subscribe: RSS

[display_podcast]

Date: March 21st, 2017

Reference: Friedman BW et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med 2017.

Guest Skeptic: Dr. Anand Swaninathan is an Assistant Professor of EM at NYU/Bellevue Hospital in the Department of Emergency Medicine. He is also part of REBEL EM, The Teaching Course and Core EM.

Case: A 43-year-old woman who presents with an acute onset of back pain. She states she was carrying some heavy boxes when she slipped and although she didn’t fall, she felt her back wrench. There are no back pain “red flags” on your history and physical examination and after some treatment with a non-steroidal anti-inflammatory (NSAID) and a dose of morphine, the patient is improved. She still has pain and you notice that she’s got difficulty walking and bending due to continued discomfort, but she says she’s late and wants to get home. You consider whether you should discharge her home with a short course of diazepam to improve her functionality.

Background: Low back pain is an extremely common presentation to US Emergency Departments representing 2.4% or 2.7 million visits annually. The vast majority of presentations are benign in etiology but can be time consuming and frustrating for both patients and physicians.

Physician frustrations with managing acute non-traumatic low back pain are multifaceted – preoccupation for finding the rare dangerous back pain patient (epidural abscesses, osteomyelitis, pathological fractures, etc), patients demanding imaging, difficulty in relieving pain and concern for secondary gain (i.e. opiate abuse or diversion).

There are multiple “Red Flag” lists to help identify patients at risk for more serious causes of their back pain. No list is comprehensive. A simple red flag list from our friend Salim Razaie (@srrezaie) at REBEL EM is called TUNA FISH.

Other things to consider would be immunocompromised patients besides just those on steroids (patients with HIV, diabetes, alcoholics or taking biologic agents) who are at risk for spinal epidural abscess, discitis, or osteomyelitis.

When it comes to patient demands for imagine, Choose Wisely from ACEP and CAEP encourages emergency physicians to avoid ordering lumbar spine imaging in patients without serious underlying conditions (red flags).

ACEP: Avoid lumbar spine imaging in the emergency department for adults with non-traumatic back pain unless the patient has severe or progressive neurologic deficits or is suspected of having a serious underlying condition (such as vertebral infection, cauda equina syndrome, or cancer with bony metastasis).
CAEP: Don’t order lumbosacral (low back) spinal imaging in patients with non- traumatic low back pain who have no red flags/pathologic indicators.

Many different treatment modalities have been tried to treat low back pain with limited success. Williams et al (Lancet 2014) showed acetaminophen did not affect recovery time compared with placebo in low-back pain. However, these were not patients recruited from the emergency department.

Friedman et al (JAMA 2015) showed that adding a muscle relaxant (cyclobenzaprine) or oxycodone/acetaminophen to an NSAID (naproxen) alone did not improve functional outcomes or pain one week after emergency department presentation.

Machado et al (Ann Rheum Dis 2017) demonstrated in a SRMA that NSAIDs did not provide clinically important effects over placebo for spine pain. They included patients with acute and chronic lumbar and cervical pain. However the point estimate for the subgroup analysis of acute low back pain was less than the pre-specified 10 point between-group difference considered clinically significant.

Conclusions: NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo. There is an urgent need to develop new drug therapies for this condition.

ACEP has some guidelines with the American Pain Society from 2007 on the use of opioids. They state opioids should be reserved for severe, disabling pain that is not controlled or not likely to be controlled with NSAIDs or acetaminophen. This will be a challenge considering the limited effectiveness of NSAIDs and acetaminophen.

The issue of opioid abuse and diversion is very large topic and will not be discussed in detail. ACEP has a clinical policy on prescribing opioids and specifically addresses patients with acute low back pain. They give three Level C recommendation:

For the patient being discharged from the ED with acute low back pain, the emergency physician should ascertain whether nonopioid analgesics and nonpharmacologic therapies will be adequate for initial pain management.
Given a lack of demonstrated evidence of superior efficacy of either opioid or nonopioid analgesics and the individual and community risks associated with opioid use, misuse, and abuse, opioids should be reserved for more severe pain or pain refractory to other analgesics rather than routinely prescribed.
If opioids are indicated, the prescription should be for the lowest practical dose for a limited duration (eg, 1 week), and the prescriber should consider the patient’s risk for opioid misuse, abuse, or diversion.

One final thing to remember is to manage patients’ expectations and not set them up for failure. They need to know their pain might not be completely relieved in the emergency department and that most patients will have persistent symptoms a week after presentation and many will have continued pain and functional impairment months after symptom onset (Itz et al 2013 , Donelson et al 2012 and Costa et al 2012). We need to be supportive and realistic when discussing the natural history of acute low back pain with patients.

Clinical Question: Does the addition of diazepam to naproxen in patients presenting with acute, nontraumatic, nonradicular low back pain improve functional outcomes at one week?

Reference: Friedman BW et al. Diazepam is no better than placebo when added to naproxen for acute low back pain. Ann Emerg Med 2017.

Population: Adults aged 21 to 69 years of age who presented to the emergency department with acute low back pain less than or equal to two weeks (Low back was defined as the lower border of the scapula to the upper gluteal folds). Patients had to have functionally impairing back pain (score > 5 on the Roland-Morris Disability Questionnaire (RMDQ)) and had to be discharged home). The RMDQ is a validated 24-item tool commonly used to measure low back pain and related functional impairment (Zero represents no impairment and 24 represents maximum impairment). A five point improvement is considered clinically significant.
- Exclusion: Radicular pain (pain below the gluteal folds, pain duration > two weeks or a baseline low pain frequency of at least once per month, absence of other non-musculoskeletal causes of pain, no direct trauma to the back, unavailable for follow-up, pregnant or breast-feeding, chronic pain syndrome and those allergic or intolerant to the use of the investigational medications.
Intervention: Naproxen 500 mg PO Q12 PRN pain + diazepam 5-10 mg PO Q12 PRN pain and a ten minute educational intervention.
Comparison: Naproxen 500 mg PO Q12 PRN pain + 1-2 placebo pills Q12 PRN pain and a ten minute educational intervention.
Outcome:
- Primary: Improvement in the RMDQ score between emergency department discharge and one week follow-up.
- Secondary: Pain intensity at one week and three months measured on a four-point descriptive scale.

Authors’ Conclusions: “Among ED patients with acute, nontraumatic, nonradicular low back pain, naproxen + diazepam did not improve functional outcomes or pain compared with naproxen + placebo 1 week and 3 months after ED discharge.”

Quality Checklist for Randomized Clinical Trials:

The study population included or focused on those in the emergency department. Yes
The patients were adequately randomized. Yes
The randomization process was concealed. Yes
The patients were analyzed in the groups to which they were randomized. Yes
The study patients were recruited consecutively (i.e. no selection bias). Yes
The patients in both groups were similar with respect to prognostic factors. No
All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Unsure.
All groups were treated equally except for the intervention. Yes
Follow-up was complete (i.e. at least 80% for both groups). Yes
All patient-important outcomes were considered. Yes
The treatment effect was large enough and precise enough to be clinically significant. No

Key Results: 545 patients were screened for enrolment with 114 patients included based on inclusion criteria. Mean age was in the mid 30’s with about 55% being men.

No improvement in functional outcome when adding diazepam to naproxen for patients with acute, nontraumatic, nonradicular low back pain.

Primary Outcome: Both the naproxen and the naproxen + diazepam group improved by 11 points on the RMDQ
Secondary Outcome: These were also comparable between the two groups.

Inclusion/Exclusion: Almost 80% of patients approached for enrolment were not enrolled. The inclusion criteria were quite narrow so the results really only pertain to a specific subset of acute back pain patients.
Recall Bias: Many of the inclusion/exclusion criteria are susceptible to recall bias (i.e. pain greater than two weeks and the RMDQ ).
Patient Population: The study took place in one urban health care system (two hospitals) serving a socioeconomically depressed population. Socioeconomic factors may be associated with back pain outcomes.
Prognostic Factors: Patients in the diazepam arm were more likely to be unemployed – a known factor in recovery in back pain patients. It was 11 (19%) for the diazepam group vs. 3 (5%) for the placebo group but still, different .
Blinding: The participants may have been unblinded in the diazepam group. They report how many patients were dizzy or tired “a lot”, which was not different. However, it is not clear how many responded “a little ”. The side effects of diazepam may not have been great enough for the patient to report being dizzy or tired a lot, as an adverse event but it may have been enough to know they were getting a diazepam. One way researchers can investigate the integrity of their blinding is to ask the patients which group they thought they were assigned. That being said, you would think any bias would have been in favour of the treatment group. Because there was not a difference found between groups it makes me believe the results even more.

Comment on authors’ conclusion compared to SGEM Conclusion: We generally agree with the authors’ conclusions.

SGEM Bottom Line: Based on the best available data, it does not appear that diazepam should be routinely added to an NSAID for outpatient management of acute, nontraumatic low back pain.

Case Resolution: Based on this data and previous work from the same group on the absence of significant benefit of opiates in acute nontraumatic back pain, I would prescribe the patient naproxen and acetaminophen for pain, make sure they have appropriate follow up and instruct the patient to stay active .

Clinical Application: The addition of diazepam to naproxen does not appear to improve acute nontraumatic low back pain outcomes. While adverse events were not significantly increased, the absence of benefit should limit this practice. Further multi-center data validating these results would be helpful.

Dr. Anand Swaminathan

What Do I Tell My Patient? I understand you’ve got a considerable amount of pain and we’re going to give you some medications that may bring your pain down a bit but it’s unlikely that we’ll be able to get rid of it completely. No matter what we do, it’s likely that you’ll continue to have this pain over the next couple of weeks or months. What we’re going to do here is make sure there isn’t a dangerous cause to your pain and then come up with a plan to help you manage it. The key after discharge is going to be staying active and moving about so that this pain doesn’t worsen.

Keener Kontest: Last weeks’ winner was Andrew Schoenling a EM resident from Henry Ford Hospital. He knew women were excluded from the ATACH2 trial if they had a child within the last 30 days.

Listen to the podcast for this weeks’ question. If you think you know the answer send an email to TheSGEM@gmail.com with “keener” in the subject line. The first person with the correct answer will receive a cool skeptical prize.

Other FOAMed Resources: