Effect of tramadol/acetaminophen on motivation in patients with chronic low back pain

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SCIENCE
Effect of tramadol/acetaminophen on motivation in patients with chronic low back pain
Key Take-Away: 
  • Following four weeks, Tramadol-acetaminophen was found to be potent at reducing chronic low back pain and conferred a prophylactic motivational effect in patients with chronic low back pain.

Apathy is characterized by loss of motivation and manifests in behaviors such as diminished motivation, poor persistence, lack of interest, indifference, low social engagement, blunted emotional response, and lack of insight. Chronic low back pain (LBP) patients have shown higher ratings of pain intensity and more comorbidities such as depression, panic/anxiety, and sleep disorders.

ABSTRACT: 
Background: 

Apathy is characterized by loss of motivation and manifests in behaviors such as diminished motivation, poor persistence, lack of interest, indifference, low social engagement, blunted emotional response, and lack of insight. Chronic low back pain (LBP) patients have shown higher ratings of pain intensity and more comorbidities such as depression, panic/anxiety, and sleep disorders.

Psychological factors, occupational disability, and somatization disorder have the potential to result in prolonged LBP. Apathy is also increasingly recognized as a common behavioral syndrome, and it is associated with negative effects including cognitive decline and decreased functioning.  However, the prevalence of apathy in chronic pain has not been studied.

Apathy and depressive mood are the two core elements of depression. Apathy is more frequently associated with functional abilities and interacts more with the recovery process than depression. Therefore, apathy disturbs not only the treatment of depression, but also the restoration of physical function. The previous reports suggest the antidepressant-like effects of tramadol-acetaminophen in chronic LBP patients with depression.

Rationale behind research

  1. The prevalence of apathy in chronic pain has not been studied and also the motivational effects of tramadol-acetaminophen in patients with chronic LBP remains unclear.
  2. Therefore, the study was conducted to investigate the frequency of apathy in chronic LBP and the therapeutic efficacy of tramadol-acetaminophen as a treatment for pain and apathy in patients with chronic LBP.
  • Objective

To investigate levels of apathy and clinical outcomes in patients with chronic LBP treated with tramadol-acetaminophen.

Methods: 

 

NOTE: This was a retrospective case control study

  • Study outcomes
  • Primary outcome:

Assessment of Apathy: Japanese translation of the 14-item Starkstein Apathy Scale was used to assess the apathy. Each item is rated using a four-point scale (0 = not at all true/characteristic to 3 = very much true/characteristic). The total scores range from 0 to 42, with higher scores indicating more severe apathy.

  • Secondary outcome:

Pain assessment: NRS (Numeric rating scale) score was used to assess the pain. It ranges from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable

Physical disability: Roland-Morris Disability Questionnaire (RDQ) was used to assess physical disability associated with back pain. The RDQ is scored on a scale of 0 to 24, with higher scores indicating greater physical disability. Pain Disability Assessment Scale (PDAS) was used to assess the negative effects of pain on broad-spectrum pain interference domains. The PDAS consists of 20 items scored using a four-point Likert scale from 0 to 3, with scores ranging from 0 to 60.

Anxiety and Depression assessment: Anxiety and depression were assessed using the Hospital Anxiety and Depression Scale (HADS). It is a 14-item scale, with seven items assessing anxiety and seven assessing depression. Each item is scored from 0 to 3 using a Likert scale. Overall scores of anxiety or depression can assume values between 0 and 21, with higher scores indicating greater severity of symptoms.

Pain Catastrophizing Assessment: Self-reported pain catastrophizing due to LBP was assessed using the Pain Catastrophizing Scale (PCS). The PCS consists of 13 items scored using five-point Likert scales ranging from 0 (never) to 4 (always) points. The maximum score for the PCS is 52, with higher scores indicating greater pain catastrophizing levels. A score >24 indicates a high level of catastrophizing.

  • Time Points:

Efficacy: Baseline and after 4 weeks of intervention

Adverse events: Baseline and after 4 weeks of intervention

Results: 

 

 

 

 

  • Baseline: There were no significant differences between two groups.
  • Primary outcomes
  • The Apathy Scale score was found to be significantly lower in the tramadol group than in the celecoxib group after treatment (P<0.05).

 

Fig 1: Apathy Scores after four-week treatment in tramadol and celecoxib groups

  • Secondary outcomes
  • The NRS (numerical rating scale) was significantly lower in the tramadol group than in the celecoxib group after treatment suggesting enhancement of internal pain control by tramadol-acetaminophen.

 

Fig 2: NRS scores after four-week treatment in tramadol and celecoxib groups

  • There were no significant differences between the treatment groups in RDQ and PDAS scores after four weeks of treatment (P = 0.08,0.77).
  • No significant difference was found between the treatment groups in the mean HADS (Hospital Anxiety and Depression Scale) anxiety scores after four weeks of treatment, while a significant difference was found in the mean HADS depression score suggesting that tramadol-acetaminophen treatment has an antidepressant effect.
  • There was no significant difference between the two groups in the PCS (Pain Catastrophizing Scale) scores after four weeks of treatment.
  • The results of mediation analysis showed that tramadol-acetaminophen was associated with change in apathy directly, not through pain relief.
  • Fourteen (38.9%) patients reported adverse events during tramadol-acetaminophen treatment, and nine (24.3%) patients reported adverse events during celecoxib treatment. The difference in the overall incidence of adverse events between the treatment groups was not significant (P = 0.18).
Conclusion: 

In this study, the frequency of apathy was investigated in chronic LBP patients. According to the Apathy Scale, apathy was present in 55.6% of patients with chronic LBP. This result was comparable to that in patients with Alzheimer disease (60%) and Parkinson disease (52.2%). 

In the present study, the combination of tramadol and acetaminophen showed efficacy not only for the reduction of pain intensity, but also for motivation, with tolerable side effects during the course of treatment. Although nausea (22.2%), somnolence (8.3%), and constipation (5.6%) were noted as side effects of tramadol-acetaminophen, all episodes of somnolence and nausea were transient, and no patients had to discontinue treatment.

The results of the current study suggest that tramadol-acetaminophen in tablet form may represent an attractive alternative treatment option for chronic LBP patients with depression or apathy.

Pain Research and Management Volume 2016

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