Fixed Combination of Tramadol/Paracetamol in the Treatment of Chronic Lower Back Pain and Its Effect on Apathy in Chronically Algic Patients

Chronic Pain and Apathy

Patients with chronic low back pain frequently experience comorbidities such as depression, anxiety, and sleep disorders. Psychological factors, work disability, and somatization disorder can lead to prolonged demonstration of low back pain. Apathy also has negative consequences on cognition and the patient's overall activity; however, the prevalence of apathy in chronic pain is not well studied. The antidepressant effects of tramadol have been described previously – this mild µ-opioid agonist is thought to improve mood by weakly inhibiting the reuptake of serotonin and norepinephrine. The analgesic effect of tramadol is significantly potentiated by concomitant administration with paracetamol. 

Apathy is defined as a loss of motivation and manifests, for example, as reduced persistence, lack of interest in activities, indifference, low social engagement, blunted emotional responses, or lack of insight. Although apathy is a common feature of neurodegenerative disorders, there is no consensus on the diagnostic criteria for apathy.

Methods and Study Course

The retrospective case-control study included 73 patients with chronic low back pain. The study cohort consisted of 23 men and 50 women with an average age of 71 years and was treated with the combination tramadol/paracetamol (n = 36) or celecoxib (n = 37). Patients in the tramadol group took fixed-dose combination tablets of tramadol/paracetamol (37.5 mg tramadol hydrochloride, 325 mg paracetamol) 2 times daily. The dosage was titrated as needed up to 4 tablets daily (150 mg tramadol hydrochloride, 1300 mg paracetamol). Patients in the celecoxib group took 2 tablets daily (200 mg celecoxib).

Participants were observed over a 4-week period with regular assessments every 7 days. The state was assessed using questionnaires, evaluating the degree of apathy (Starkstein Apathy Scale), pain (on a scale of 0–10), the degree of anxiety and potential depression (Hospital Anxiety and Depression Scale), pain catastrophizing (Pain Catastrophizing Scale), and the degree of physical limitations related to low back pain (Rolland-Morris Disability Questionnaire).

Results

55.6% (n = 35) of patients met the criteria for apathy. During the 4-week treatment regimen, the tramadol/paracetamol group showed significant improvement in apathy scores (from 16.2 ± 5.3 to 12.8 ± 5.7) and pain ratings on a 0–10 scale (from 7.5 ± 1.4 to 3.7 ± 1.8). In the celecoxib group, no changes were observed in apathy scores (from 15.5 ± 6.1 to 15.9 ± 6.2) and smaller changes were noted in pain ratings (from 6.9 ± 2.1 to 4.5 ± 1.9).

The depressive component assessed by the Hospital Anxiety and Depression Scale was also lower in the group treated with the tramadol/paracetamol combination (from 7.2 ± 4.0 to 4.9 ± 3.1) compared to the group treated with celecoxib (from 7.2 ± 3.8 to 6.9 ± 4.1).

Mediation analysis using the bootstrapping method found that the effect of tramadol/paracetamol on changes in apathy was not mediated by pain relief.

Conclusion

Pain therapy with fixed-dose combination medicinal products such as tramadol/paracetamol may provide more effective pain relief due to its synergistic analgesic effect. The study confirmed the efficacy of the fixed combination of tramadol/paracetamol on chronic low back pain, and this therapy simultaneously carried a prophylactic motivational effect on the studied cohort of patients.

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Source: Tetsunaga T., Tetsunaga T., Tanaka M. et al. Effect of tramadol/acetaminophen on motivation in patients with chronic low back pain. Pain Res Manag 2016: 7458534, doi: 10.1155/2016/7458534.