Abstract
Objective and Design:
The purpose of this 6-week Before-After trial was to investigate the effectiveness of the Natura Mattress System in reducing back pain by ≥ 1 unit on the 11-Point Pain Severity Scale (p ≤ 0.05), in chronic low back pain sufferers.
Subject Profile:
The subjects were adults recruited from within and outside the Canadian Memorial Chiropractic College (CMCC) Outpatient Clinic, with chronic low back pain (LBP) of ≥ 2 months duration at the time of entering the study.
Sample Size:
15 subjects were targeted to complete the study.
Outcome Measures:
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.
Statistical Analysis:
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.
Methods Protocol:
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.
Results:
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.
Conclusion:
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 ≤ 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.
Keywords: sleep, bed, foam mattress, back pain, clinical trial
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- Coyne C., Baier W., Perra B., Sherer B. K. Controlled trial of backrest elevation after coronary angiography. Am J Crit Care. 1994 Jul;3(4):282–288. [PubMed] [Google Scholar]
- Garfin S. R., Pye S. A. Bed design and its effect on chronic low back pain--a limited controlled trial. Pain. 1981 Feb;10(1):87–91. doi: 10.1016/0304-3959(81)90049-X. [DOI] [PubMed] [Google Scholar]
- Grandjean E. Fatigue in industry. Br J Ind Med. 1979 Aug;36(3):175–186. doi: 10.1136/oem.36.3.175. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Jensen M. P., Karoly P., Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986 Oct;27(1):117–126. doi: 10.1016/0304-3959(86)90228-9. [DOI] [PubMed] [Google Scholar]
- Linde L., Bergström M. The effect of one night without sleep on problem-solving and immediate recall. Psychol Res. 1992;54(2):127–136. doi: 10.1007/BF00937141. [DOI] [PubMed] [Google Scholar]
- Scriver V., Crowe J., Wilkinson A., Meadowcroft C. A randomized controlled trial of the effectiveness of exercise and/or alternating air mattress in the control of back pain after percutaneous transluminal coronary angioplasty. Heart Lung. 1994 Jul-Aug;23(4):308–316. [PubMed] [Google Scholar]
- Smith A., Maben A. Effects of sleep deprivation, lunch, and personality on performance, mood, and cardiovascular function. Physiol Behav. 1993 Nov;54(5):967–972. doi: 10.1016/0031-9384(93)90310-c. [DOI] [PubMed] [Google Scholar]
- Steyvers F. J., Gaillard A. W. The effects of sleep deprivation and incentives on human performance. Psychol Res. 1993;55(1):64–70. doi: 10.1007/BF00419894. [DOI] [PubMed] [Google Scholar]
- Wu J. C., Gillin J. C., Buchsbaum M. S., Hershey T., Hazlett E., Sicotte N., Bunney W. E., Jr The effect of sleep deprivation on cerebral glucose metabolic rate in normal humans assessed with positron emission tomography. Sleep. 1991 Apr;14(2):155–162. [PubMed] [Google Scholar]