The design and methods of the aging successfully with pain study

Abstract

Chronic low back pain (CLBP) is widespread among older adults (≥ 65 years) and is often treated inadequately. With a rapidly growing aging population, CLBP will increase and so will the demand for treatment. We believe that mind-body therapies can help to meet this demand. We present the methodology of a randomized, controlled clinical trial of 300 individuals with CLBP aged 65 years or older. The specific aims are, 1) to determine the effectiveness of a mindfulness meditation program in increasing function and reducing pain among older adults with CLBP, and 2) to evaluate the impact of mindfulness meditation on neuropsychological performance in older adults with CLBP. The intervention program is modeled on the Mindfulness-Based Stress Reduction Program (MBSR) and the control is adapted from the 10 Keys™ to Healthy Aging. We will measure self-reported and objectively measured physical function and include a variety of measures to assess pain intensity and pain interference and psychological function. Our primary hypothesis is that the MBSR program will be more effective than the 10 Keys™ program in increasing function and decreasing pain. The proposed study represents the first large, well-controlled, comprehensive examination of the effects of a mind-body program on older adults with chronic pain.

Introduction

Among the 37 million older adults (≥ 65 years) alive today[1], it is estimated that up to 50% live with chronic pain [2]. More than 17 million of them have experienced at least one episode of low back pain during the past year [3], and it is the most frequently reported musculoskeletal problem [4]. Pain is associated with significant morbidity in the older adult, including decreased physical function, increased disability, decreased quality of life, poor sleep, and depression [5]. Despite its prevalence and associated morbidities, older adults suffer from inadequately treated pain. Conventional treatment options are not always feasible for the older adult. NSAIDs are limiting due to well-described gastrointestinal and nephrotoxic side-effects [6]. Opioids are associated with increased susceptibility to falls and fractures [7]. Millions of individuals suffer from compromised quality of life because of frequent pain episodes [3]. There is an urgent need for safe and effective therapies to relieve chronic pain in the older adult.

The multidimensional nature of pain lends itself to the multidimensional approach of mind-body medicine. Pain researchers have long recognized the complexity of a painful stimulus and have described not only a sensory component, but a cognitive and emotional element as well. Processing of a nociceptive stimulus involves sensory perception and motivational and affective responses. In turn, mind-body therapies are based on a comprehensive approach for the patient to address various dimensions of pain. Mind-body therapies like mindfulness meditation teach patients to work with the sensory, cognitive, and affective responses to pain. Because mind-body therapies do not involve medication, they offer a relatively safe treatment option for older adults who may have exhausted other forms of pain therapy. We describe the methodology of a randomized controlled trial of an 8-week mindfulness meditation program (Mindfulness-Based Stress Reduction [8] (MBSR) vs. an educational program (the 10 Keys™ to Healthy Aging [9]) in older adults with chronic low back pain (CLBP).

Kabat-Zinn, who introduced mindfulness meditation to the medical community, described mindfulness as “the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment ” [10]. Previous research by Kabat-Zinn showed a significant reduction of pain among 90 patients with chronic pain conditions [11]. He published 4-year follow-up showing maintenance of pain improvement among 60–72% of 225 chronic pain patients [12]. 63 patients with rheumatoid arthritis were randomized to an MBSR program or a control program. Six-months after program completion, there was significant improvement in psychological distress and well-being [13]. Other studies have found that mindfulness meditation is associated with reduction in depression, anxiety, and stress [14], [15], [16]. Although these results are compelling, the studies present methodological problems as some lacked randomized controls, had small sample sizes, and included heterogeneous pain conditions and ages.

Because of the emphasis of mindfulness meditation on sharpening one's attention to the present moment's experience, researchers have been actively studying its effects on neuropsychological performance. One aspect of neuropsychological performance is attention. Mindfulness meditation has been found to improve attention among a healthy population who took the 8-week MBSR program as compared to a control group [17]. In addition to attention, executive function is also an important neuropsychological dimension and which can be tested with the Stroop task. This common test was used among healthy college students and those who were taught mindfulness meditation as compared to an active or passive control performed better on the Stroop [18]. Because of mindfulness meditation's promising potential to affect neuropsychological performance, we will measure these two domains of neuropsychological performance (attention and executive function). Improving neuropsychological performance may be one of the mechanisms by which mindfulness meditation works.