Managing sleep with Zopiclone in acute low back pain. A feasibility study.

INTERVENTION: The intervention is Zopiclone, considered an effective and safe, hypnotic medication with minimal adverse effects and mild chance of abuse, dependence, and tolerance and no withdrawal. Prior to enrollment each participant will be screened by their GP or a research physician at the Woolcock Institute of Medical Research or Neuroscience Research Australia (NeuRA). The participant will be required to take the intervention every night for 14 nights. A standard single dose of 7.5mg will be taken shortly before bedtime for 14 days. The most commonly reported adverse event is bitter taste. Overall disturbances are rare and mild in intensity, however the participant will be reminded that they can withdraw at any time if they no longer feel comfortable taking the intervention. The intervention will be given orally in a capsule form. The participants will be asked to return the empty drug packet to monitor adherence. CONDITION: Acute low back pain Acute mild‐moderate Insomnia PRIMARY OUTCOME: Mean pain intensity measured by Pain Intensity Numerical Rating Scale. ; ; Childs, J. D., Piva, S. R. & Fritz, J. M. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila. Pa. 1976). 30, 1331–1334 (2005) Mean sleep quality, calculated from 14 nightly measures of the 11‐point Numerical Rating Scale of sleep quality from the modified Pittsburgh Sleep Diary (PghSD). ; ; Monk, T.H, Reynolds III, C.F., Kupfer, D.J., Buysse, D.J., Coble, P.A., Hayes, A.J., Machen, M.A, Petrie, S.R., Ritenour, A.M., The Pittsburgh Sleep Diary. J. Sleep Res (1994) 3, 111‐120 SECONDARY OUTCOME: Depression and Anxiety (DASS‐21) ; ; Ronk, F. R., Korman, J. R., Hooke, G. R. & Page, A. C. Assessing clinical significance of treatment outcomes using the DASS‐21. Psychol. Assess. 25, 1103–10 (2013). Drowsiness (Epsworth Sleepiness Scale) ; ; Johns, M. W. Reliability and factor analysis of the Epworth Sleepiness Scale. Sleep 15, 376–381 (1992). DynaPort Move Monitor measuring movement and body position during the night Fatigue (The Flinders Fatigue Scale (FFS)) ; ; Gradisar, M. et al. The flinders fatigue scale: Preliminary psychometric properties and clinical sensitivity of a new scale for measuring daytime fatigue associated with insomnia. J. Clin. Sleep Med. 3, 722–728 (2007). Global recovery (The Patient Global Back Recovery Scale (GBRS)) ; ; Hush, J. M., Kamper, S. J., Stanton, T. R., Ostelo, R. & Refshauge, K. M. Standardized measurement of recovery from nonspecific back pain. Arch. Phys. Med. Rehabil. 93, 849–855 (2012). Insomnia (Insomnia Severity Index) ; ; Alsaadi, S. M. et al. Detecting insomnia in patients with low back pain: accuracy of four self‐report sleep measures. BMC Musculoskelet Disord 14, 196 (2013). ; Objective Measure of movement intensity while asleep, using Actiwatch Participant Satisfaction (Participant Satisfaction Questionnaire) Risk of chronic disability measure by the (Orebro Musculoskeletal Pain Screening Questionnaire (OMPSQ)) ; ; Hockings, R. L., McAuley, J. H. & Maher, C. G. A systematic review of the predictive ability of the Orebro Musculoskeletal Pain Questionnaire. Spine (Phila. Pa. 1976). 33, E494–E500 (2008). Sleep Effort (The Glasgow Sleep Effort Scale) ; ; Broomfield, N. M. & Espie, C. a. Towards a valid, reliable measure of sleep effort. J. Sleep Res. 14, 401–407 (2005). INCLUSION CRITERIA: 1. Low back pain. 2. Mild to moderate insomnia (Insomnia Severity Index score of between 7‐21), of less than 6 weeks duration 3. Sufficient understanding of written and verbal English language.