None listed
Conditions
Brief summary
Clinical audit data suggests that electrical stimulation of the spinal cord is an effective treatment for chronic pain. but only a few high-quality experimentally-controlled studies of this treatment have been reported. We now wish to investigate effects of this stimulation on pain and associated symptoms (sleep and mood) in a double-blind randomised controlled trial. Specifically, we will compare pain and sensitivity to painful stimuli pressure and sharpness) while the stimulator is switched on and 3-4 days after the stimulator has been switched off. As BurstDR parasthesia free stimulation itself produces no detectable sensations, we will use a double blind strategy to investigate effects of stimulation (i.e , neither the participant nor investigator will know whether the stimulator is switched on or off). The therapeutic benefits of electrical stimulation will be evaluated in the patients own environment while they carry out their normal activities. The patient will monitor their pain, mood, analgesic consumption and sleep over 8 3-4 day blocks. The stimulator will be switched off during two of these blocks.
Interventions
Over a 28 day period patients with a previously implanted Burst DR electical spinal cord stimulator will have their device switched off for two out of eight three to four day cycles . These 'off' periods will not be consecutive and will be determined by a computer randomisation program. Neither the patient or research assistant will know whether the stimulator device is on or off, this is controlled by a technician. Patients will fill out daily questionnaires and pain behaviours will be assessed
Sponsors
Abbott Medical Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients will have been implanted with a BurstDr electrical stimulator, and will report significant pain relief (defined as average pain less than 3/10 from their stimulator ) and minimal requirements for analgesic medication ( defined as less than 20 Morphine Equivalent Dose (MEq) ) and without any accompanying sensation from electrical stimulation.
Exclusion criteria
Patients without BurstDr Stimulators Patients with BurstDR Stimulators that do not report significant pain relief Patients with BurstDR Stimulators that report significant pain relief but experience parasthesia Patients that have pain "washout"and " wash in"intervals ( ie when the device is switched off and then on again ) of longer than 2 days
Outcome results
None listed