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Can the Fixed Combination of Tramadol/Acetaminophen Significantly Reduce Back Pain Uncontrolled by NSAIDs?

9. 10. 2020

One way to prevent drug-related complications in the treatment of lower back pain (LBP) while improving patients' functioning in daily activities is the prescription of the weak opioid agonist tramadol in combination with acetaminophen. A smaller Japanese observational study focused on the effectiveness of this treatment in reducing the disability of patients with chronic LBP, improving their daily activities, and the occurrence of adverse events.

Introduction

Lower back pain, (low back pain), is a clinical syndrome defined by pain, increased muscle tension, and a feeling of stiffness in the area between the lower edge of the ribs and the gluteal folds, with potential pain projection to the lower limbs.

We refer to back pain that persists for more than 3 months as chronic. It is a relatively common condition and is usually treated with nonsteroidal anti-inflammatory drugs (NSAIDs). However, their chronic use can have some undesirable side effects, especially in older individuals: in addition to gastrointestinal problems, they can also reduce renal function. These complications can be avoided with the use of tramadol, a weak opioid that can improve chronic back pain and limited mobility.

Study Methodology and Course

The presented work monitored 24 patients with chronic lower back pain unrelieved by NSAIDs. There were 10 men and 14 women with an average age of 65.1 ± 12.1 years. They were prescribed a fixed combination of tramadol and acetaminophen (37.5 mg/325 mg) 4× a day, which they used for 1 month. At the beginning, after 1 week, and after 1 month of use, the following parameters were evaluated: leg pain and lower back pain (VAS - visual analog scale), everyday activities (RDQ - Roland-Morris Disability Questionnaire), and loss of mobility (ODI - Oswestry Disability Index).

Results

Leg pain was significantly more severe than back pain in the subjects, but it disappeared during the first week of treatment (p = 0.00093), while lower back pain improved after 1 month of using the tramadol and acetaminophen combination (p = 0.00034).

Average RDQ (p = 0.015) and ODI (p = 0.0032) scores also improved after 1 month of use. For one patient, the pain improved so much that they canceled a planned surgery for a narrowed spinal canal.

A total of 41.6% of study participants reported nausea and a bloated feeling at the start of therapy, and 12.5% (4 patients) discontinued treatment because of this. None of the patients observed experienced confusion. For 25% of patients, tramadol and acetaminophen administration did not improve chronic lower back pain.

Conclusion and Discussion

The fixed combination of tramadol and acetaminophen is preferred over chronic NSAID use because it has fewer undesirable gastrointestinal and renal side effects. Tramadol titration reduces the incidence of nausea. This was an observational, not a comparative, study; thus, broader research is needed to assess the long-term effectiveness of the tramadol and acetaminophen combination in older patients with chronic lower back pain unresponsive to NSAIDs.

(mir)

Source: Imamura T. Significant efficacy of tramadol/acetaminophen in elderly patients with chronic low back pain uncontrolled by NSAIDs: an observational study. Open Orthop J 2015; 9: 120−125, doi: 10.2174/1874325001509010120



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