Low back pain is one of the most common health problem. The lifetime prevalence of low back pain is between 60% and 85%. Low back pain also exacts a significant cost on society.
Current recommendations for the management of low back pain include early mobilization and physical activity. Acetaminophen, NSAIDs, and muscle relaxants are recommended to reduce pain and improve function within the first 6 weeks. Spinal manipulation therapy is also recommended in such cases.
NSAIDs have been demonstrated to improve low back pain compared with placebo, according to a 2008 systematic review by the Cochrane Collaboration Review Group. However, NSAIDs also increased the risks for adverse events compared with placebo. These improvements using NSAIDs v placebo are modest, and whether NSAIDs confer greater benefit than acetaminophen (paracetamol) is controversial.
The body of research into the efficacy of spinal manipulative therapy is more complicated and difficult to interpret. Spinal manipulative therapy was significantly superior to sham therapy, resulting in a mean of 10 mm of improvement v sham (fake) therapy. However, spinal manipulation therapy was not superior to general practitioner care, analgesics, physical therapy, back exercises, or back school. The authors examined variables affecting pain outcomes, and they found that the profession of the person performing spinal manipulation did not alter the main study result.
The current study puts these treatments to the test in a common practice environment. Patients seeking relief of acute low back pain in general practitioners' offices were eligible for study participation. All participants were given paracetamol 1 gm to be taken 4x daily until complete recovery or a maximum of 4 weeks elapsed. Subjects were assigned to receive diclofenac 50 mg 2x daily and placebo spinal manipulation therapy, spinal manipulation therapy and placebo tablets imitating diclofenac, or double placebo. Spinal manipulation therapy was delivered 2 or 3 times per week and allowed for the use of high-velocity thrust procedures according to the judgment of experienced physiotherapists.
The primary outcome was the number of days until either the first pain-free day or the first of 7 consecutive days with at least minimal pain. Secondary outcomes included pain, function, and disability.
There were 240 patients with moderate levels of pain and disability at baseline who underwent randomization. On average, subjects took approximately two thirds of the recommended dose of paracetamol and 72% of the recommended dose of diclofenac. The median number of spinal manipulation therapy sessions per week was 2.3, and only a small percentage of subjects underwent high-velocity thrust techniques.
In both the spinal manipulation therapy group and the placebo group, the median number of days to recovery was 15. Even the combination of diclofenac and spinal manipulation therapy failed to promote faster rates of improvement vs double placebo. Moreover, both active treatments failed to improve secondary outcomes of pain, disability, or function compared with placebo. Participants reported that the overall perceived effect was similar regardless of study treatment.
The authors of the current study address a major reason for the negative results in their study compared with results of previous research on NSAIDs for acute low back pain. They note that many of these earlier trials failed to include clinicians' advice for basic back care as well as regular treatment with paracetamol. Although NSAIDs and spinal manipulation therapy may be more effective than placebo, the current research suggests that they are no more effective than paracetamol and sound advice.
At the same time, NSAIDs raise significant safety concerns. The prevalence of NSAID-related gastropathy is approximately 25% to 50% among chronic NSAID users. Furthermore, a meta-analysis that examined the gastrointestinal risk associated with specific NSAIDs found that NSAIDs increased the risk for all gastrointestinal complications by 54%. NSAIDs can have deleterious effects on the kidneys as well.
Spinal manipulation therapy also has possible adverse consequences. In a review of the medical literature regarding spinal manipulation therapy published between 2001 and 2006, researchers found that more than 200 patients receiving spinal manipulation were suspected to have been seriously harmed. Most data regarding serious adverse effects were from case reports, and vertebral artery dissection was identified as the most common serious adverse event. Mild adverse events of spinal manipulation therapy were very common, occurring in 30% to 61% of all patients.
The current study by Hancock and colleagues would certainly suggest that the added cost and adverse events associated with spinal manipulation therapy are not justified by more rapid improvement in low back pain. In addition, the study suggests that patients should not be exposed to the risk of taking NSAIDs when there is little added therapeutic benefit associated with such treatment. It is also worth noting that recent research into the early prescribing of opioids for low back pain found this practice to be associated with higher mean disability duration, elevated mean medical costs, and an increased risk for surgery and late opioid use compared with usual practice.
Although it may be difficult for both patients and providers to accept that time appears to be the best therapy for low back pain, most cases of back pain improve significantly within 2 weeks, and 90% of patients report significant improvement at 2 months. Clinicians should certainly encourage appropriate activity and recommend paracetamol/acetaminophen to improve symptoms of acute low back pain, but it appears that giving the body time to recover is the key element of treatment. This common diagnosis requires prescriptive restraint, and patients will benefit from this practice in the long run.
(Excerpted from: Hancock MJ, Maher GC, Latimer J, et al: Assessment of Diclofenac or Spinal Manipulative Therapy, or Both, in Addition to Recommended First-line Treatment for Acute Low Back Pain: A Randomized Controlled Trial. Lancet 2007;370:1638-1643)
