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

Not Applicable

• Conditions: Acute mild-moderate Insomnia; Acute low back pain; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12616000017426
• Lead Sponsor: Dr. James McAuley

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-01-13
• Study Completion: 2017-03-31
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 22

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.

Exclusion Criteria

1.Known allergy to sedative drugs
2. Diagnosed with sleep disorder including sleep apnea, primary hypersomnia, narcolepsy, circadian rhythm disorder, parasomnia or dyssomnia.
3. Diagnosed with a psychiatric disorder
4.Diagnosis serious hepatic disorder
5.Diagnosis severe myasthenia gravis
6.Diagnosis acute narrow angle glaucoma
7.Major surgery or blood donation in the past 12 weeks
8.Pregnancy or expected pregnancy, or breastfeeding
9. Have a history of substance abuse or substance dependence subjects with alcohol abuse.
10. Weekly consumption more than 14 units (women) or 21 units (men) of alcohol.
11.Daily consumption of more than the nicotine-equivalent of 15 cigarettes a day.
12.Daily consumption of more than 5 caffeine-containing beverages a day/ caffeine consumption of >500 mg/day
13.Flew >2 time zone in the past month or will have to do so during course of the study
14. Working night shifts and unable or unwilling to discontinue this work pattern
15.Presented with any condition that would prevent normal management of low back pain such as cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean pain intensity measured by Pain Intensity Numerical Rating Scale. <br><br>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)[Average pain assessed at 14 days];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). <br><br>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[14 nights of the intervention period. <br><br>]