None listed
Conditions
Brief summary
This project aims to, for the first time, examine the effectiveness of portable, home-based transcranial direct current stimulation (tDCS) to reduce pain and disability in people with acute low back pain. Such data may provide novel insights into whether early tDCS could feasibly prevent chronic pain development. Further, potential mechanisms underlying any observed effects of tDCS on pain and function will be explored by investigating corticomotor organisation, somatosensory function, EEG, and affective-emotional characteristics as possible mediating factors. Given that no study has investigated the treatment in this context, safety, adherence, and tolerability will be examined. This may facilitate the development of an effective, inexpensive, and home-based means by which to manage low back pain, reducing the associated social, financial, and physical burden. We hypothesise that home-based tDCS will be a safe, effective, and well-tolerated means of reducing pain and disability in people with acute low back pain, with minimal or no adverse effects.
Interventions
Intervention group: active transcranial direct current stimulation (tDCS)
A trained investigator will fit the tDCS headpiece and give a detailed demonstration of how to operate the device. A checklist for set-up and operation of the device and an instructional video regarding correct headpiece positioning will be provided for use at home. Participants will then be assessed on their ability to administer and operate the device safely against checklist procedures, and if able to complete all proc
Intervention group: active transcranial direct current stimulation (tDCS) A trained investigator will fit the tDCS headpiece and give a detailed demonstration of how to operate the device. A checklist for set-up and operation of the device and an instructional video regarding correct headpiece positioning will be provided for use at home. Participants will then be assessed on their ability to administer and operate the device safely against checklist procedures, and if able to complete all procedures they will be permitted to continue in the trial. Participants in the intervention group will receive 20 minutes of active tDCS on ten consecutive days. This period of tDCS is consistent with the available literature in chronic pain conditions and laboratory-based studies. During active tDCS, stimulation with a constant current intensity of 2 mA will be applied over the motor cortex using a Soterix mini-CT Stimulator (Soterix Medical Inc.) with a coded study mode to facilitate randomisation and blinding. The current is delivered via two 5x7cm saline-soaked sponge electrodes, fitted into a custom headpiece, with the anode electrode placed over M1 contralateral to the side of worst LBP using the International 10-20 system at position C3 or C4 (according to side of pain). The reference electrode (cathode) will be placed on the side ipsilateral to pain and positioned over the supraorbital region. These positions will be set up at the initial baseline assessment, and participants will not be required to adjust them. Each day, participants will receive a single-use treatment code, which they input into the device to commence the stimulation. They will not be able to modify the settings. Participants will be instructed to sit comfortably and minimise movement throughout the session, but will be permitted to engage in activities such as reading or watching TV. Participants will keep the headpiece in position for a duration of 20 minutes until the tDCS unit turns off automatically and generates a completion code. Adherence to the use of home based tDCS will be assessed using a digital platform (ElectraRx, Soterix Medical Inc., 2024, Woodbridge, USA) which is programmed with the treatment schedule for each participant. If a participant does not send their completion code to be entered into ElectraRx by a researcher, the platform will record the session as missed. The tDCS device usage will also be checked by accessing the “Stimulation History” on each tDCS device, which is located within the passcode-protected “Administration” menu, and recording the number of completed sessions for each participant. The first tDCS session will be administered in the laboratory under supervision of the research team, following the baseline testing and tDCS set up described above. For the first home-based session, participants will be supervised by researchers via secure videoconferencing software (Zoom Video Communications, Inc., CA) to provide support and monitor for adverse events. All subsequent sessions will be self-administered without the research team present, and participants will be monitored throughout the two-week period via daily text messages and online questionnaires, and weekly phone calls. If a participant fails to respond for two days, they will be contacted via email or phone. Previous studies in neuropsychiatric populations have demonstrated that self-administered, home-based tDCS without supervision is well-tolerated and safe.
Sponsors
Dr Rocco Cavaleri - Western Sydney University
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 No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants must be 18 years of age or older and experiencing acute or subacute LBP – defined as pain in the region between the 12th thoracic vertebra and the gluteal fold, present for at least 7 days and no more than 8 weeks at the time of enrolment. Participants with referred pain beyond this region may be included provided there are no clinical signs of radicular pain from neural tissue involvement, as assessed by an experienced physiotherapist. For participants with a previous history of LBP to be eligible, they must have experienced a period of at least one month pain-free prior to the current episode. As part of the screening process, pain intensity will be recorded for all prospective participants using a 10cm visual analogue scale (VAS) and only those reporting a minimum average weekly pain intensity of 4/10 during screening will be included. Participants must provide written informed consent to participate, be able to speak, read and understand instructions in English, and be able to attend laboratory appointments at Western Sydney University in Campbelltown, Australia.
Exclusion criteria
Participants will be excluded if they are suspected to have radiculopathy or lumbosacral radicular pain, as determined by an experienced physiotherapist using previously employed diagnostic criteria. All potential participants will be screened for red flags in accordance with the NSW Agency for Clinical Innovation guidelines. Those identified with red flags will be advised to attend the nearest Emergency Department and will be excluded from the study unless subsequently medically cleared of serious spinal pathology (e.g. fracture, tumour, cauda equina syndrome). Participants with a history of lumbar spinal surgery, comorbid acute or chronic pain conditions, a history of a chronic pain condition in the past 12 months, current or past history of a significant neurological disorder, or other comorbidities affecting sensorimotor processes will also be excluded. All potential participants will be screened for contraindications to TMS and home-based tDCS (e.g. epilepsy, electronic or metal implants in the head, cognitive impairment) using the TMS/tDCS Adult Safety Screen questionnaire and excluded if any are present. Participants will also be asked to provide a log of any medications they take currently and within the month preceding the trial, including medication type, frequency and dosage. Participants will be excluded if they take any medications thought to interfere with tDCS (e.g. benzodiazepines) or with cognitive or sensory function (e.g. opioid intake greater than daily morphine equivalent 40mg). Participants will be excluded if they are unable to understand instructions and complete questionnaires provided in English.
Outcome results
None listed