Exploring whether home-based neuromodulation can prevent the transition from acute to chronic low back pain
- Conditions
- Low back painMusculoskeletal - Other muscular and skeletal disorders
- Registration Number
- ACTRN12624001143516
- Lead Sponsor
- Dr Rocco Cavaleri - Western Sydney University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 40
Eligible participants must be 18 years of age or older and be currently experiencing acute LBP – defined as pain in the region between the 12th thoracic vertebra and the gluteal fold, present for at least 24 hours and no more than 3 months. Participants with referred pain beyond this region may be included provided there is no suspicion of radicular pain from neural tissue involvement. For participants with a history of LBP to be eligible, there must have been a period of at least one month pain-free prior to the current episode. As part of the screening process, numeric pain rating scale (NPRS) values will be recorded for all prospective participants and only those reporting a minimum average weekly pain intensity of 3/10 will be included.
Participants will be excluded if they present with suspected nerve root involvement (e.g. dominant leg pain, positive neural tissue provocation tests and/or any two of altered strength, reflexes, or sensation for the same nerve root, assessed clinically); suspected major spine pathology (e.g. fracture, tumour, cauda equina syndrome); history of lumbar spinal surgery; other acute or chronic pain conditions; neurological disorders or other comorbidities affecting sensorimotor processes; other musculoskeletal impairments beyond the lower back; history of psychiatric disorders requiring pharmacological management (e.g. major depressive disorder, bipolar disorder, schizophrenia) and/or contraindications to home-based tDCS (e.g. physical and/or cognitive inability to operate device safely and reliably, epilepsy, previous adverse reaction to NIBS, metallic/electrical implants at stimulation site). Participants will also be asked to provide a log of any drugs they take currently and within the month preceding the trial, including medication type, frequency and dosage. Participants will be excluded if they take any drugs thought to interfere with tDCS (e.g. benzodiasepines).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pain intensity[Visual analogue scale (VAS) Baseline, daily for two weeks during intervention, immediately post-completion of intervention, weekly for weeks 1-12 post-completion of intervention (12 weeks/3 months is the primary timepoint)];Mechanical sensitivity measured via pressure pain threshold (PPT)[PPTs will be measured using a pressure algometer (Somedic, 1-cm2 probe). Subjects will be asked to push a button when the sensation changes from one of pressure to pain. The point at which pressure sensation first becomes pain will be used to determine pressure pain threshold. This value will be measured and recorded at baseline and following intervention. Baseline, 1 week, 1, 2 and 3 months post-completion of intervention (primary timepoint)]
- Secondary Outcome Measures
Name Time Method