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Date: August 27th, 2021
Reference: Gagnon et al. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. AEM 2021
Guest Skeptic: Dagny Kane-Haas is a physiotherapist who also has a master’s degree in Clinical Science in Manipulative Therapy.
Case: A forty-year-old woman presents to the emergency department (ED) with a sore lower back after moving some boxes at home over the weekend. She tried acetaminophen with limited relief. Her pain is eight out of ten on the zero-to-ten-point numeric pain rating scale (NPRS). She has no red flags (TUNA FISH) and is diagnosed as having mechanical back pain without imaging as per ACEP Choosing Wisely. You know mechanical low back pain is difficult to treat effectively and are trying to set expectations. While preparing her for discharge you wonder if seeing a physiotherapist before going home from the ED would improve her outcome.
Background: Acute and chronic back pain has been covered many times on the SGEM. There is no high-quality evidence that acetaminophen, NSAIDS, steroids, diazepam, muscle relaxants or combinations of pharmacologic modalities provide much relief.
- SGEM#87:Let Your Back Bone Slide (Paracetamol for Low-Back Pain)
- SGEM#173: Diazepam Won’t Get Back Pain Down
- SGEM#240: I Can’t Get No Satisfaction for My Chronic Non-Cancer Pain
- SGEM#304: Treating Acute Low Back Pain – It’s Tricky, Tricky, Tricky
We do know that opioids are very effective at reducing many types of pain including muscular skeletal pain. However, opioids have many side effects and concerns about substance misused.
The ACEP 2020 clinical policy on the use of opioids states:
“Preferentially prescribe nonopioid analgesic therapies (nonpharmacologic and pharmacologic) rather than opioids as the initial treatment of acute pain in patients discharged from the emergency department. For cases in which opioid medications are deemed necessary, prescribe the lowest effective dose of a short-acting opioid for the shortest time indicated.” (Level C Recommendation)
There are several non-pharmaceutical treatments that have also been tried to treat low back pain. They include: Cognitive Behavioural Therapy and mindfulness (Cherkin et al JAMA 2016), chiropractic (Paige et al JAMA 2017), physical therapy (Paolucci et al J Pain Research 2018) and acupuncture (Colquhoun and Novella Anesthesia and Analgesia 2013). None of these other treatments has high-quality evidence supporting their use.
We have covered a randomized control trial looking at acupuncture to treat painful conditions presenting to the ED, including acute back pain, on SGEM#187. That trial reported no difference in clinical or statistical relevant reduction of pain at one hour between groups (acupuncture only, acupuncture plus pharmacotherapy or pharmacotherapy alone). However, we have not done a structured critical appraisal of an RCT looking at physiotherapy for this clinical condition.
Clinical Question: Does access to a physiotherapist in ED help patients who present with minor musculoskeletal disorders (MSKD)?
Reference: Gagnon et al. Direct-access physiotherapy to help manage patients with musculoskeletal disorders in an emergency department: Results of a randomized controlled trial. AEM 2021
- Population: Adult patients 18-80 years of age presenting to the ED with suspected minor MSKD, traumatic or not. Minor was defined using the Canadian Triage and Acuity Scale (CTAS) score of 3, 4 or 5.
- Excluded: Non-minor MSKD (ex: open fractures or open wounds), red flags, clinically unstable, hospitalized patients, or those in long-term care facilities.
- Intervention: Physiotherapist evaluated the patient post triage in the ED. They would recommend interventions based on their clinical assessment. This could include advice, technical aids, imaging, prescribed or over-the-counter medication, and consults with other health care professionals. However, there was no follow-up by the physiotherapist.
- Comparison: Usual care
- Outcome:
- Primary Outcome: Pain and function at one and three months. Pain was assessed using a NPRS. Function was evaluated using the Pain inventory subscale of the short version of the Brief Pain Inventory (BPI). The BPI scores ten activities of daily living (e.g., general activity, mood, walking, work, sleep) on a zero-to-ten-point scale (0 – no interference with function and 10- completely interferes with function)
- Secondary Outcomes: Utilization of resources at ED discharge, interventions utilized, medications, healthcare professionals consulted, return ED visits and imaging received.
Authors’ Conclusions: “Patients presenting with a MSKD to the ED with direct access to a PT had better clinical outcomes and used less services and resources than those in the usual care group after ED discharge and up to 3 months after 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). No
- The patients in both groups were similar with respect to prognostic factors. No
- All participants (patients, clinicians, outcome assessors) were unaware of group allocation. No
- All groups were treated equally except for the intervention. Yes
- Follow-up was complete (i.e. at least 80% for both groups). No
- All patient-important outcomes were considered. No
- The treatment effect was large enough and precise enough to be clinically significant. No
Results: They recruited 78 patients into the trial. The mean age was 40 years and 56% were male.
Key Result: Lower pain scores and better function in the physiotherapy group compared to usual care at both one and three months.
- Primary Outcome: Pain (NPRS) and function (BPI)
- Secondary Outcomes: Control Compared to Physical Therapy (PT). Not applicable (NA), not statistically different (NSD) and over the counter (OTC) medications
1. Consecutive Patients: This was a consecutive recruitment of a convenience sample. The recruitment was only 13 hours per week between the hours of 1pm and 9pm Monday to Friday depending on the physiotherapists schedule. In contrast, emergency medicine is 24/7/365. This selective recruitment could introduce bias and impact external validity to those patients who present on nights, weekends, and holidays.
2. Differences in Groups: Those in the control group were older, more often male and had a higher initial pain score. These differences could have been a result of the block randomization process used to balance area of body affected and not age or sex. The authors did try to control for these factors in their analysis.
3. Lack of Blinding: They did not describe the extent of blinding in the trial. The participants would have known they were seeing a physiotherapist. It is unclear if they were familiar with the hypothesis. It is also not reported if the clinicians were blinded. This lack of blinding could have introduced bias. Getting more attention during the initial visit from another health care professional could have impacted their initial pain and function scores and possibly those at one and three months. If the clinicians knew about the trial they could have altered their usual care.
4. Small Sample Size with Large Loss to Follow-Up: The a priori sample size was calculated on the minimum clinically important difference (MCID) of the BPI estimated to be 1.00. This required a total of 90 patients to be recruited into the trial. The final cohort consisted of 78 patients. They did not reach their target number of patients due to a lack of funds.
A quality metric we look for is less than 20% loss to follow-up. They had about 20% loss to follow-up at the 1-month and 3-month outcome. There were differences in those who sex, age and initial pain scores in those that were lost to follow-up and those who were not. This makes me more skeptical of the results.
5. Outcomes: They had four primary outcomes with pain and function being assessed at one and three months. This increases the chance of a Type I error where the null hypothesis is falsely rejected (false positive).
The point estimate of effect size difference between groups was statistically significant. However, the 95% confidence interval for minimally important clinical difference was crossed for both pain and function at one and three months. Given the multiple other threats to validity (small convenience sample, baseline difference, lack of blinding and loss to follow-up) makes us more skeptical that there is a meaningful clinical difference.
Comment on Authors’ Conclusion Compared to SGEM Conclusion: While the conclusions are correct, we think they are incomplete. It would have been better to put in a caution statement about the small sample size, lack of blinding and loss to follow-up to put the conclusions in context.
SGEM Bottom Line: Physiotherapy looks promising as a potential intervention for patients with mild MSKD presenting to the ED, but we need better trials to confirm these preliminary findings with clinically significant outcomes before recommending their implementation.
Case Resolution: You recommend ibuprofen 400mg to see if that works better than the acetaminophen and try to set reasonable expectations.
Clinical Application: It is nice to see an RCT done looking at PT in ED and getting a positive outcome. However, these results need to demonstrate a clinically meaningful outcome and confirmed before applying clinically.
What Do I Tell the Patient? You have likely strained your lower back from lifting boxes on the weekend. This can be very painful. Acetaminophen and ibuprofen may help but it is unlikely get rid of your pain completely. People have tried other things besides medications to help like physiotherapy. We do not have great evidence that it works well but it is something you may consider trying. Unfortunately, some people who strain their back can have pain for a few weeks or even months. Try to stay active and, if your pain is getting worse, you can’t function, or are otherwise worried please return to the ED for re-assessment.
Keener Kontest: Last weeks’ winner was Jacob Miller a Flight Nurse Practitioner in Cincinnati Ohio. He knew Stranger Things was the Netflix show set in the town of Hawkins, Indiana, that the song Never Ending Story appear in the season finale.
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