Thursday, May 16, 2013

Who Benefits from Integrative Pain Therapy?

Integrative Pain ManagementIn light of increasing concerns about a reliance on pharmacotherapy for chronic noncancer pain conditions, there has been renewed emphasis on integrative — multidisciplinary and multimodal — pain management approaches focusing on biopsychosocial models. A pair of recently-reported observational studies examined outcomes of integrative pain management programs, finding that they are not beneficial for all patients and are highly dependent on patient characteristics and treatment components.

Study A: Multidisciplinary Treatment of Chronic Widespread Pain (CWP)

Research exploring the effectiveness of multidisciplinary approaches for the treatment of chronic widespread pain (CWP) has been limited, largely due to considerable heterogeneity among patients. Therefore, a research team from Amsterdam, The Netherlands, headed by Aleid de Rooij conducted an observational trial to identify predictors of integrative treatment outcomes in patients with CWP [de Rooij et al. 2013]

The researchers enrolled 120 patients with CWP, including fibromyalgia, in a prospective longitudinal study. Mean age of participants was 45 years, 95% were female, and their pain level at baseline on average was 6.1 on a 0-10 NRS. Several outcome domains were assessed — including pain, pain interference, depression, and global perceived effect (GPE) — at baseline and at a 6-month followup.

The main goal of the intervention was to teach patients to cope with pain and to reduce the interference of pain in daily living. The treatment included cognitive behavioral therapy (CBT), pain management skills (eg, goal setting, structuring of daily activities, pacing strategies, ergonomics), physical training (eg, exercise), relaxation training, education about neurophysiology and medication management, and assertiveness training.

Treatment interventions were tailored to patients’ goals and were administered in groups and on an individual basis. Group sessions took place during 7 consecutive weeks, 7 hours per week, and individual sessions were offered during a period of 4 to 6 months with a variable frequency per patient. The multidisciplinary team involved rehabilitation physicians, physiotherapists, occupational therapists, psychologists, and social workers.

Writing in BMC Musculoskeletal Disorders, de Rooij and colleagues report that there was virtually no change in pain scores on NRS from baseline to followup at 6-months (Cohen’s d calculated from study data = 0.0; p=0.96). This apparently was consistent with goals of the interventions, which were not directed toward pain relief per se.

There was a minimal but statistically significant effect size favoring the interventions on reducing pain interference (d=0.18; p=0.02), and a small statistically significant effect of the interventions on alleviating depression (d=0.34; p<0.001). On the measure of perceived global effect, roughly half (48.3%) of the patients reported improvement, while the remainder self-reported no change/worse.

Despite these nominal improvements at 6-months associated with the moderately intensive multidisciplinary approach, the researchers report a number of factors as being important for predicting which patients might benefit most…

  • Greater improvement in pain was predicted by more pain at baseline and male gender.

  • Greater improvement in interference of pain in daily life was predicted by more interference at baseline, lower levels of anxiety, a stronger belief in personal control, male gender, and a higher level of education.

  • Greater improvement in depression was predicted by higher baseline values of depression, stronger beliefs in personal control, and a higher level of education.

  • Better outcome on GPE was predicted by less pain, less fatigue, and a higher level of education.

The researchers conclude that less pain and fatigue, less anxiety, stronger beliefs in personal control, higher level of education, and male gender are important predictors of better outcomes of integrative treatment programs addressing CWP. Tailoring such programs to these specific patient characteristics, or careful selection of eligible patients for multidisciplinary treatment, may further improve treatment outcomes.

Study B: Intensive Interdisciplinary Program for Chronic Back Pain

In background information for this study, Juraj Artner and colleagues from the Department of Orthopaedic Surgery, University of Ulm, Germany, suggest that chronic back pain is relatively resistant to unimodal therapy regimes [Artner et al. 2012]. Therefore, the aim of their retrospective analysis was to evaluate the short-term outcomes of a 3-week integrative, multidisciplinary outpatient program for patients with back pain and sciatica. Primary outcomes of interest were decreases in pain and functional impairment.

There were 160 patients included in the study who had back pain for ≥12 weeks, including those with nonspecific back pain, disc herniation without paresis, facet joint disease, or spinal stenosis. Average age was 57 years (range 22-88), mean pain score on 0-10 NRS at baseline was 6.03, and 56% were females.

The integrative pain management program was multifaceted, consisting of medical treatment (including up to 8 interventional injection procedures), exercise therapy, back education, ergotherapy, physical therapy (eg, traction, massage, thermal therapy, stretching, fango [ie, mud therapy], breathing gymnastics, etc), psychotherapy, behavioral management, transcutaneous electrical nerve stimulation, aqua-training, and relaxation techniques. During a very intensive schedule, participants attended program sessions 5 days/week, 9 hours each day, for 3 weeks.

At the conclusion of the 3-week multimodal intervention, results demonstrated a large, statistically and clinically significant 67% reduction in pain scores on NRS (Cohen’s d calculated from study data = 2.44; p<0.0001). Scores for functional impairment, on the Oswestry Disability Index, decreased more moderately, but still significantly by 33.33% (d=0.65; p<0.0001).

The researchers conclude that their intensive outpatient interdisciplinary program for chronic back pain achieved good short-term clinical results in terms of relieving functional disability and pain. Further research is needed to better define the optimal match of patient and program characteristics for sustaining long-term benefits.

As evidenced by the 2 studies, integrative pain management following a biopsychosocial model — emphasizing both functional restoration and intrapersonal skills that reduce pain interference with daily living — incorporates a wide range of interventions. Although the studies addressed different pain conditions, it seems of some concern that the results were so disparate in terms of providing pain relief, which could be a clinical outcome of importance to patients.

Clearly, the more intensive and comprehensive 3-week program in Study B was most efficacious in relieving pain, with mean NRS scores reduced from 6.03 to 2.00, as well as in reducing functional impairment. Still, both studies had major limitations:

  • Neither study had a control group, so it is difficult to know the extent to which the interventions themselves contributed to outcome results, or whether nonspecific effects (merely due to the intensiveness of therapy) or placebo effects played roles.

  • Both studies incorporated a broad mix of interventions, particularly Study B, and it is impossible to determine which were most and least effective in contributing to outcome goals. Since there would be a cost in time and money associated with each, it would be important to know what works best to facilitate development of standardized, cost-effective approaches.

  • Followup times for both studies were inadequate. It would be important to know whether outcome results persisted for at least 12 months or longer (eg, 2-3 years) to assess clinical efficacy of the intensive programs.

  • Although pain-relief was not a stated goal of Study A, it is curious that mean NRS pain scores did not change at all during the 6-months of the study (remaining at a moderate 6.0 level). Furthermore, improvements in pain interference, depression, and global effect were unspectacular.

  • Additionally in Study A, only 5% (6/120) of participants were male, yet statistical regression analyses determined that being male was an important predictor of treatment success. This may be an example of how statistics sometimes overreach what the data are truly capable of representing. Similarly, it is difficult to understand how greater improvement in pain could be predicted by more pain at baseline, as the researchers claim, when this measure on average remained virtually unchanged throughout the study.

  • Study B outcomes may have been confounded by incorporating interventional injection procedures (up to 8 per subject) and modifications of analgesic medications (details unspecified) during a brief 3-week period. In fact, this was sternly criticized in a followup letter to the editor by several German researchers [Kaiser et al. 2013].

Integrative — interdisciplinary and multimodal — pain therapy has been defined as a simultaneous, contextual, temporal, coordinated, and comprehensive strategy to treat patients with chronic pain, integrating different somatic, physical, and psychological treatment approaches by an interdisciplinary therapeutic team with consensual therapeutic aims [Kaiser et al. 2013]. Often, coordination of the team is under the supervision of a pain specialist physician.

The U.S. Agency for Healthcare Research and Quality (AHRQ) suggests there are 4 main elements of an interdisciplinary approach: 1) medical care, 2) physical reconditioning, 3) behavioral medicine, and 4) education. Intensive programs described in the literature range from 4 to 40 hours per week, and the number of weeks is highly variable [Artner et al. 2012].

A mixture of passive and active modes are usually incorporated. Passive modes would include things done to the patient (eg, interventional procedures, medications, massage, electrical stimulation or ultrasound, etc.); whereas, active modes require greater patient participation (eg, exercise, psychological and behavioral therapies, etc.). A standardized recipe for the best mix of active and passive modalities has not been determined, nor is there agreement regarding the frequency and amount of treatments.

Clearly, integrative pain management programs can be time and resource intensive; thereby, incurring considerable expense. There are still questions as to the most advantageous approaches that will meet individual patient needs and expectations, and for which pain conditions. And, as Study A suggests, certain patients may benefit more than others. Finally, there are unresolved issues regarding patient access to such programs and their affordability.

> Artner J, Kurz S, Cakir B, et al. Intensive interdisciplinary outpatient pain management program for chronic back pain: a pilot study. J Pain Res. 2012;5:209-216 [
article PDF here].
> de Rooij A, van der Leeden M, Roorda LD, et al. Predictors of outcome of multidisciplinary treatment in chronic widespread pain: an observational study. BMC Musculoskel Dis. 2013;14:133 [
article PDF here].
> Kaiser U, Arnold B, Pfingsten M, et al. Multidisciplinary pain management programs [letter]. J Pain Res. 2013;6:355-357 [
PDF here].

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