In our previously published paper19
, we documented that using the TIVR for four months post-group CBT resulted in improvements in measures of pain, mental health, coping, and in physical performance. As we demonstrate in the current report, in addition to maintaining or improving gains in clinical outcomes, patients in the TIVR group also reported a decrease in mean dose of opioid analgesics and NSAID medication use at the post-TIVR assessment compared to the baseline. The decrease in opioid analgesic mean dose persisted at the final 8-month post-CBT follow-up, four months after access to the TIVR was terminated. In addition, some subjects in the TIVR group discontinued using opioids or NSAIDS altogether. In contrast, the control group showed significant increases in mean dose of the opioid analgesics and other medication use by the 8-month follow up. Furthermore, in the control group the number of patients taking opioid and NSAID medications increased. Group differences in medication use were significant for opioid analgesics at the 8-month and NSAIDS at the 4-month follow-ups.
The mean anti-depressant dose increased for both groups from baseline to all follow-ups, although the increase was not significant for the TIVR group by 8-month follow-up. Antidepressants remain a common treatment modality in this population although their efficacy for treating chronic musculoskeletal pain per se remains controversial31
. Debate continues over whether there are analgesic effects distinct from antidepressants’ effects on mood8, 23, 27
. In our study, the improvements in clinical outcomes were not related to increases in antidepressant usage.
Since individual subjects were treated by different physicians and were not taking the same medications, it was necessary to calculate equivalence doses. To our knowledge this is the first study with calculated equivalence doses for a wide range of opioid analgesics, NSAIDS, benzodiazepines and antidepressants, in order to evaluate an efficacy of pain management. We developed our own equivalency formulas for the first three classes of drugs using guidelines provided by the American Pain Society17
and Goodman & Gilman's The Pharmacological Basis of Therapeutics10
Results demonstrate that the telephone based Therapeutic Interactive Voice Response relapse prevention program can be used not only to decrease pain, improve coping, and diminish likelihood of relapse into pain behavior but also concurrently decrease opioid and NSAIDS medication use. As opioid analgesics are frequently used in the management of chronic musculoskeletal pain, Therapeutic IVR might therefore help patients with chronic pain to reduce the risk of adverse events associated with opioid treatment. These include but are not limited to constipation with the increased risk for bowel obstruction, hip fracture related to falls, and cognitive impairment, as well as long-term sequelea including increased opioid tolerance and/or hyperalgesia with decreased opioid efficacy and iatrogenic dependency26
. While most prescription opioid use is not associated with abuse or addiction, it remains an important and preventable cause of addictive behavior and frank substance abuse. There is therefore a need for optimized pharmacologic and non-pharmacologic treatment strategies for the management of chronic non-malignant pain and TIVR might be one of the answers.
There are a few limitations that must be considered when interpreting our results. First is the relatively small sample size. In our study, opioid analgesics use was not an inclusion criterion. While all of our subjects used some form of pharmacotherapy, only 29 out of 51 reported using opioid analgesics and 38 out of 51 reported NSAIDS at any of the assessments. This resulted in fewer subjects for the medication effect analyses. The demographic composition is also skewed since the sample is predominantly female and there are only two minority group members. The latter is reflective of the demographic composition of the state of Vermont. We are aware that some of the findings of this study might be related to the fact that that subjects participating in the CBT groups are self–selected. For instance, we noticed that women were less likely to drop out of the groups and were more inclined than men to comply with the phone-based relapse prevention program.
A current ongoing RCT addresses some of the limitations with a larger sample and a longer follow-up. For instance, we are presently collecting more detailed information related to subjects’ pain treatment including the frequency of doctors’ visits, visits to the emergency department, hospitalizations, and medication side effects. Our present study also tests the effectiveness of TIVR without individually-tailored monthly messages as this component is time consuming and therefore expensive.
Also the TIVR technology could be further refined to customize the user experience. For example while our TIVR system uses a female voice, it might be possible to offer either female or male voices to subjects based on preference. Other improvements might include combining IVR technology with computer-based technology to be able to display customized graphs and figures based on results of daily data. For those who are e less inclined to participate in group CBT and/or are keener to use computers, a free standing computer-based CBT program with relapse prevention follow-up might be an ideal solution to capture this chronic pain population.
Finally, in light of the encouraging results of this study, future research plans include creating combination of phone- with computer- based technology to create special Therapeutic Computer and IVR program (TCIVR) tailored to chronic pain patients treated with opioid analgesics.
To our knowledge there is no other self-directed treatment program that has demonstrated efficacy as a tool for pain coping skills maintenance enhancement and concomitant opioid medication use reduction. As our telephone-based program was designed as a post-CBT pain coping skills maintenance enhancement, we were particularly gratified to see that patients using this tool not only continued to improve 8 months post CBT (four months after the TIVR program was completed) but also that they simultaneously decreased their opioid analgesics and NSAID medication use. If our findings are replicable, we believe that using the TIVR as a CBT based relapse prevention program would also be an efficacious and cost-effective treatment for opioid medication use reduction. In the future, we hope to determine if this combination of CBT with TIVR could enhance long-term treatment outcomes in patients with persistent pain and concomitant opioid dependence. We postulate that the TIVR’s applicability can be extended to the patient population at high risk for developing illicit analgesic medication abuse and dependence.