None listed
Conditions
Brief summary
CLBP is a disabling condition worldwide, associated with huge economic costs. Current available treatments, targeting low back structures that are believed to be associated with pain and disability, demonstrate at best small effect sizes, thus warranting the need for new innovative therapies. In individuals with CLBP, brain imaging studies demonstrate abnormal electrical activities in the specific cortical areas that are responsible for pain modulation, emotional and sensory components of the pain experience. Moreover, these altered cortical activities are associated with pain severity and chronicity. Targeting those key brain regions may produce clinical benefits. Non-invasive external brain stimulation technique [Transcranial electrical stimulation (TES)] has considerable potential as a treatment for CLBP due to its relatively low cost, safety, portability, and ease of use compared with other brain stimulation methods. The proposed research will evaluate the feasibility and safety, and explore the effect of a novel TES technique on pain, function, and psychological measures in individuals with CLBP. The evidence obtained from this study will help us to develop novel interventions to improve the health outcomes in individuals with CLBP.
Interventions
Transcranial electrical stimulation will be administered five times a week (30 minutes/session, once daily on weekdays) for a total of 4 weeks (i.e. 20 sessions in total) using a 32 channel transcranial current stimulator (Starstim-Home 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
Transcranial electrical stimulation will be administered five times a week (30 minutes/session, once daily on weekdays) for a total of 4 weeks (i.e. 20 sessions in total) using a 32 channel transcranial current stimulator (Starstim-Home 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 circular stimulation electrodes placed on it. For the active treatment group, the high definition transcranial infraslow pink noise 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. For sham stimulation, to create an identical skin sensation to the active stimulation, the actisham protocol created by neuroelectrics will be used. The current will be applied for a 60s ramp up (0-2mA) and 60s ramp down (2-0mA) at the beginning and the end of each stimulation session, without any current for the remainder of the stimulation period. Adherence to intervention will be measured by the principal investigator as the number of treatment sessions attended by each participant, and expressed as a percentage of the total number of sessions. Adherence rates will be calculated once the treatment phase is completed. Treatment fidelity will be assessed by the principal investigator at each session, who will supervise that the treatment is delivered in a standardized manner as planned. The treatment delivered for each participant for each session will be saved on the NIC2 computer software.
Sponsors
Dr Divya Adhia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants with a diagnosis of chronic low back pain (CLBP) will be eligible to participate. To be included in the study, participants must meet all of the following 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 or equal to 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 or waiting/scheduled for any procedures within the next six months •Current intake of any centrally-acting medications or intention of taking new medications in the next 3 months. •Recent steroid injections to the back (in the past 6 months) •Radicular pain and radiculopathy •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