It may be a prevalent practice, but the use of acetaminophen for acute low back pain does not decrease recovery time, according to a new Australian study of over 1,700 patients who participated in a randomized placebo-controlled trial.
"Our results convey the need to reconsider the universal endorsement of paracetamol [acetaminophen] in clinical practice guidelines as a first-line care for low back pain," authors of the study write, "and suggest that advice and reassurance, rather than analgesics, should be the focus of first-line care." The study was published online in the July 24 edition of The Lancet (abstract only available for free).
For the study, patients reporting low back pain (pain between the 12th rib and buttock crease shorter than 6 weeks' duration preceded by 1 month of no pain) were divided into 3 groups: a regular-dose group, an as-needed group, and a placebo group. Each group was supplied with 2 boxes of tablets—1 box contained tablets to be taken every 6–8 hours, and another box contained tablets that could be taken "as needed" for pain relief. The regular-dose group received 665 mg acetaminophen tablets in the "take regularly" box and placebo tablets in the "take as needed" box; the as-needed group received 500 mg tablets in the "take as needed" box and placebos in the "take regularly" box; the placebo group received placebos in all boxes. Participants were instructed to continue taking the tablets until they recovered or for 4 weeks, whichever occurred first.
Researchers found median recovery times (defined as a self report of 0–1 on the 0–10 pain scale maintained for 7 consecutive days) for all 3 groups to be nearly identical, at 17 days for the regular-dose and as-needed groups, and 16 days for the placebo group. "Our findings suggest that regular or as-needed dosing with [acetaminophen] does not affect recovery time compared with placebo in low back pain, and question the universal endorsement of [this drug] in this patient group," authors write.
The study's authors also note that participants in the study recovered at a somewhat faster rate "than that typically reported in other cohorts … receiving miscellaneous or usual treatments," and write that for the differences may be attributed to the provision of "good quality advice and reassurance, a feature that is often absent from usual care."
"While we cannot disregard the possibility of a placebo effect … the provision of advice and reassurance of the favorable prognosis might be the more important factor in the management of acute low back pain than drug therapy," the authors write.
APTA low back pain resources include a MoveForwardPT.com webpage on low back pain, clinical practice guidelines on low back pain (.pdf), and an APTA Learning Center presentation on manipulation for low back pain. PTNow provides full-text access to the latest clinical practice guidelines and Cochrane systematic reviews related to low back pain and neck pain.
Research-related stories featured in PT in Motion News are intended to highlight a topic of interest only and do not constitute an endorsement by APTA. For synthesized research and evidence-based practice information, visit the association's PTNow website.
If past problems are any indication of how the future might go, a Centers for Medicare and Medicaid Services (CMS) proposal to require prior authorization for durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) could "impede or delay access to timely medically necessary care" due to a lack of sufficient infrastructure to efficiently administer the new requirement, according to APTA comments recently submitted to CMS.
In a July 25 letter (.pdf) to CMS Acting Administrator Mary Tavenner, APTA applauds the CMS effort to reduce fraud and abuse with DMEPOS use, but warns that the agency's track record on payment review systems doesn't bode well for fullscale implementation of a plan to mandate authorization reviews for devices and supplies that often require quick patient access. The proposed rule states that CMS contractors will use "reasonable efforts" to issue authorization decisions within 10 days of the receipt of a standard request, or 2 business days for an "urgent" decision. In both cases, APTA points out, the waits "could result in serious decline of a beneficiary's health and safety," particularly if an urgent request is submitted on a Thursday or Friday and a patient must wait over a weekend for a decision.
Matters have the potential to be made worse, APTA suggests, should the CMS contractors lack sufficient expertise and infrastructure to make informed, timely decisions—problems that have cropped up in other payment review systems, most notably in manual medical reviews for patients exceeding $3700 in outpatient therapy services. The association cites federal government reports that point to problems with lack of specificity in denial rationales, "flawed logic" in tracking systems, contractor statements backed by questionable facts, inaccessibility for providers, poor customer service, and lack of clinical expertise.
APTA acknowledges the need for a focus on DMEPOS utilization, but suggests that if CMS chooses to move ahead with a prior authorization system, it do so incrementally, with "a small set of items … tested to determine whether the proposed protocols can be operationalized on the front lines of care delivery before the program is launched nationally."
"APTA recognizes that oversight of DMEPOS utilization is necessary; however, it is of limited value if delays cause detrimental health impacts on beneficiaries or impose additional administrative and financial burdens on providers and suppliers due to operational and technical issues," the letter states. "The prior authorization process should neither delay the provision of care, nor be overly burdensome to providers or patients."
APTA will update its DMEPOS resource webpage when this rule becomes final and the specific DMEPOS items subject to the rule have been selected.
Note: see table 4 of the proposed rule for a list of items that may be chosen for prior authorization.
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