Back Pain Clinical Studies
Approximately two-thirds of chronic pain patients complain of poor sleep and fatigue. For many low back pain patients, the inability to get a good night’s sleep significantly degrades their quality of life. A clinical study was designed to explore the relationship between low back pain, sleep quality and the sleeping surface. The research facilities, Sister Kenny Institute at Abbott Northwestern Hospital, and Physical Therapy at the Marsh Health Center specialize in the treatment of chronic low back pain. The studies were conducted in response to hundreds of customer testimonials which suggested a link between a Sleep Number® bed with adjustable firmness and some amount of back pain relief.
Chronic low back pain sufferers were randomly recruited by the research facilities to participate in the studies. Subjects received an unmarked Sleep Number bed similar in size to their existing innerspring mattress which had to be less than five years old. Overall, the study population had equal gender representation, at least one half in the 40 – 55 age range, and no more than 25% diagnosed with the same cause for back pain. Additionally, all were screened to be absent of a diagnosed sleep disorder.
Sixty (60) subjects (30 male and 30 female) with an average age of 49.5 (25 – 79) were screened for evidence of chronic low back pain. The study started with the delivery of the unmarked sleep surface matched to the subject’s original innerspring mattress. each subject completed an initial SF-36™ Health Survey. This survey has been used for years to determine a patient’s current health status and well being. Subjects also completed the epworth Sleepiness scale and visual analog pain and sleep scales before switching to the Sleep Number bed. Subjects completed the visual analog scales for the next 28 days. At that point, the subjects completed another SF-36™ and epworth and then switched back to their original innerspring mattress. The subjects continued to record visual analog scales for nights 29 – 42. At the conclusion of the studies, the subjects completed their third and final SF-36™ and Epworth.
Subjects reported improved pain relief on the SF-36™ when sleeping on the Sleep Number bed compared to their original innerspring surface (p = 0.0001). Study participants recorded improved sleep quality (p = 0.0013) and pain relief (p = 0.0012) as recorded on their daily visual analog scales. Subjects reported improved overall health on the SF-36™ as follows: improved physical function (p = 0.0015); role physical (p = 0.0001); general health (p = 0.012); vitality (p = 0.002); role emotional (p = 0.038); mental health (p = 0.027); and epworth (p = 0.018). For each comparison, a matched pairs one-tailed t-test was performed. If any p-values were less than 0.10, a nonparametric Wilcoxin signed rank test was performed.
In this study, the Sleep Number bed provided improved pain relief and sleep quality for a statistically significant number of subjects with chronic low back pain. 93% of subjects reported back pain relief and 89% reported improved sleep.