The purpose of this 6-week Before-After trial was to investigate the effectiveness of the Natura Mattress System in reducing back pain by ¡Ý 1 unit on the 11-Point Pain Severity Scale (p ¡Ü 0.05), in chronic low back pain sufferers.
The subjects were adults recruited from within and outside the Canadian Memorial Chiropractic College (CMCC) Outpatient Clinic, with chronic low back pain (LBP) of ¡Ý 2 months duration at the time of entering the study.
15 subjects were targeted to complete the study.
The primary outcome measure consisted of: morning severity of pain as measured by an 11-point ordinal pain scale (Numeric Rating Scale or NRS). Secondary outcome measures consisted of: (1) daily quality of sleep as measured by a 4-point ordinal scale; (2) effect on daily activity as measured by a 4-point ordinal scale; and (3) daily quantity of analgesics. These outcomes were collected via a daily diary-type of questionnaire.
Baseline to 4-week post treatment-commencement differences were analyzed for statistical significance using Repeated Measures ANOVA, at the 0.05 level of significance. In addition, all outcome measures were graphed and examined descriptively for any clinically important changes across the 6 week time-frame of the study.
Eligible subjects who read and signed the written informed consent form, were given a package containing a copy of the written informed consent form, and upon completing the 2 week baseline daily diary questionnaires, were contacted by the bed manufacturer, who arranged with the subject a date and time of mutual convenience to deliver the bed (twin or queen size). The subject was then required to complete 4 more weeks of diary questionnaires. Thank-you cards were sent to each subject who completed the study.
The sample consisted of 6 caucasian females and 7 caucasian males, between the ages of 22 and 75 years, with an average(sd) age of 37.0 (18.44) years. Five subjects were adult students, 5 had sedentary occupations, while 3 had relatively physical occupations. Baseline low back pain (LBP) severities of the sample ranged from 2 to 8 on the 11 point pain scale (NRS), with an average(sd) level of 3.0 (1.75). Average duration of the subjects¡¯ chronic LBP state was 5.6 years, ranging from 3 months to 30 years. Only 2 subjects were taking LBP medications at the start of the study.
For a generally well educated, young (20-40 years of age), caucasian population with mild-moderate chronic LBP, use of the Natura Bed can be expected to result in a clinically important reduction in pain severity upon both waking and at the end of the day, of at least 1 point (on the NRS) over a 4 week period (p ¡Ü 0.05).
Further research is recommended which utilizes the Randomized Clinical Trial (RCT) design to investigate the performance of the Natura Bed compared to other beds on the market, and assesses patient characteristics predicting suitability for the Natura Bed.
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