None listed
Conditions
Brief summary
Aims and research design The aim of this pilot study is to assess the feasibility of a randomised controlled trial aimed to improve sleep of patients with low back pain, using a hypnotic drug called Zopiclone, which is a currently available drug approved by the Therapeutic Goods Administration. Methods In accordance with recommendations for pilot studies this pilot will recruit thirty-two participants. Participants will have acute low back pain and a co-existing sleep disturbance. Participants will be randomly allocated to one of two study groups of equal sizes. Patients in both groups will be encouraged to continue with their usual care, one group will receive placebo, while the other group also will receive Zopiclone over the course of 14 days. Procedure Participants who have sleep apnoea or severe insomnia will be excluded. As this is a pilot study the primary aim of this study is to use the data obtained to refine recruitment, outcome measures and randomisation procedures for a larger trial. A secondary aim of this study is to estimate the effect of managed sleep on acute low back pain from the 95% confidence intervals. There have been no other studies to date that have evaluated the feasibility of controlling sleep as a way of improving low back pain. As this is a feasibility study the primary outcome measure has not yet been defined. The participants will be asked to complete a Pittsburgh Sleep diary and a numeric rating scale (NRS) to rate their average pain intensity daily for the first 14 days. During this time participants will be asked to wear an actiwatch overnight. The actiwatch measures movement during sleep and therefore it is an indirect measure of sleep quality. Participants will be asked to complete a Low back screening questionnaire and Global perception of change scale. These measures were selected because they are widely employed to assess persistence in low back pain. Psychological factors including depression and anxiety will be measured using the DASS. Participants will also be asked to rate next day effects using a Flinders fatigue scale and an Epsworth sleepiness scale. Conclusion. This trial aims to conclude whether or not it is feasible to do a large scale randomised placebo controlled trial.
Interventions
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 sh
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.
Sponsors
Dr. James McAuley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Outcome results
None listed