Functional Impact of PENS for 65+ Chronic Low Back Pain

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DESCRIPTION (provided by applicant): Chronic low back pain (CLBP) plagues greater than 6 million community dwelling older adults, and causes physical and psychosocial dysfunction as well as increased utilization of health care resources. While the mainstay of treatment for these individuals consists of non-opioid analgesics and physical therapy (PT), frail older adults with unrelieved symptoms have limited therapeutic alternatives. Opioid analgesics and surgical treatment may be inapplicable to those with prohibitive physical or cognitive comorbidities. Many individuals with chronic musculoskeletal pain seek out complementary and alternative treatments, although most have not been subjected to rigorous scientific investigation. Acupuncture is among the most commonly employed of these modalities. The purpose of this investigation is to explore the utility of percutaneous electrical nerve stimulation (PENS), a neuroanatomically guided form of electroacupuncture, as a safe non-pharmacologic analgesic alternative for the older adult with CLBP. In order to optimize physical performance and diminish disability, the value of a general conditioning and aerobic exercise (GCAE) program with and without PENS will also be studied. A randomized controlled clinical trial will be performed. Two hundred community dwelling older adults equal to or > age 65 with CLBP will receive either (1) PENS alone, (2) sham PENS alone, (3) PENS + GCAE, or (4) sham PENS + GCAE, twice a week for 6 weeks. All outcome measures will be collected pre-treatment, at the completion of the 6 weeks protocol, and 6 months later. Primary outcome measures include pain intensity (short form McGill Pain Questionnaire) and pain-related disability (Roland Disability Scale). Because chronic pain is a complex, multidimensional experience, important secondary outcome measures will also be collected that assess key aspects of (1) physical function (self-reported and performance-based), (2) psychosocial function (mood, self-efficacy, self-rated health, cognitive coping, fear, sleep), and (3) health care utilization. This study represents the first well-controlled, comprehensive examination of an alternative medicine intervention for CLBP in older adults. If effective, this trial could lead to improved quality of life for millions of suffering older Americans, and by diminishing pain intensity and the use of toxic analgesic regimens, lead to substantial cost savings by decreasing health care utilization.