None listed
Conditions
Brief summary
Resting-state cortical activity alterations have been demonstrated in individuals with chronic low back pain. Recent evidence suggests that alterations in the functional connectivity patterns between the pain processing regions [pregenual anterior cingulate cortex (pgACC), dorsal anterior cingulate cortex (dACC), and primary somatosensory (SSC)] are critical for maintaining chronic pain and are associated with its clinical and psychological outcomes. This study will explore the effect of the high-definition transcranial infraslow pink noise stimulation technique on the current density and functional connectivity of the pgACC, dACC, and SSC. We hypothesise that this new stimulation technique will be able to alter the brain activity and connectivity at the targeted regions, when compared to sham stimulation technique.
Interventions
High-definition transcranial infraslow pink noise stimulation (HD-tIPNS) will be administered for a single session of 30 minutes using a 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain), by a researcher with health professional background and considerable experience in administering non-invasive neuromodulation techniques. The participants will be positioned comfortably and quietly in a seated/half lying position on a bed, and will wear a neoprene head cap with
High-definition transcranial infraslow pink noise stimulation (HD-tIPNS) will be administered for a single session of 30 minutes using a 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain), by a researcher with health professional background and considerable experience in administering non-invasive neuromodulation techniques. The participants will be positioned comfortably and quietly in a seated/half lying position on a bed, and will wear a neoprene head cap with 32 circular stimulation electrodes placed on it. For the active treatment group, the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
• Capable of understanding and signing an informed consent form • Age between 18 to 75 years on the day of the consent • Pain in the lower back area (region between the 12th rib and the gluteal fold) that occurs every day for more than or equal to 3 months • A score of more than 4 on the 11-point numeric pain rating scale (NPRS, 0 is No pain to 10 is Worst pain) in the past 4 weeks • A disability score of more than or equal to 5 on Roland–Morris Disability Questionnaire
Exclusion criteria
•Inflammatory arthritis •Undergoing any therapy from a health professional (e.g. physiotherapists or chiropractor) •Recent soft tissue injuries of the back in the last 3 months •History of surgery to the back region •Current intake of any centrally-acting medications or intention of taking new medications on the treatment day. •Recent steroid injections to the back (in the past 6 months) •History of neurological diseases •Unstable medical or psychiatric conditions •History of epilepsy or seizures •Presence of any peripheral neuropathy or vascular pathology •Alcohol or substance abuse •Dyslipidaemia •Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease) •History of uncontrolled/untreated hypertension •Presence of any pacemaker or defibrillator •Presence of any electronic implants or metal implant in the body (particularly head and neck) •Recent or current pregnancy
Outcome results
None listed