None listed
Conditions
Brief summary
The UPWARD study is a National Health and Medical Research Council funded project being carried out by Neuroscience Research Australia and Western Sydney University. It is a long-term study (5 years) that will follow participants for 6 months from the onset of their low back pain in order to understand why some individuals get better after hurting their back while others do not. This information will help clinicians design more appropriately timed and targeted therapies for people with low back pain.
Interventions
Participants experiencing an acute episode of low back pain (less than 6 weeks duration) will be included and followed for 6 months. Eligible participants will complete tests that assess characteristics of the sensory and motor cortex, individual capacity for neuroplasticity and psychological status at baseline. Fifteen candidate predictors are selected a priori based on a theoretical association with the development of chronic LBP. Methods for obtaining measures of candidate predictors are out
Participants experiencing an acute episode of low back pain (less than 6 weeks duration) will be included and followed for 6 months. Eligible participants will complete tests that assess characteristics of the sensory and motor cortex, individual capacity for neuroplasticity and psychological status at baseline. Fifteen candidate predictors are selected a priori based on a theoretical association with the development of chronic LBP. Methods for obtaining measures of candidate predictors are outlined below. Sensory and anterior cingulate cortex activity: Sensory evoked potentials will be recorded in response to electrical stimulation of the paraspinal muscles through surface electrodes positioned ipsilateral to the side of worst low back pain. Primary sensory cortex activity (S1) is recorded using electroencephalography via gold plated cup electrodes (Digitimer, Reusable Au and Ag EEG Cup Electrodes) positioned over S1 (3 cm lateral and 2 cm posterior to Cz) on the side contralateral to worst low back pain and referenced to Fz according to the International 10/20 EEG placement system. Two blocks of 500 stimuli are recorded for each participant. Motor cortex activity: Single-pulse, monophasic transcranial magnetic stimulation (TMS) is delivered to the primary motor cortex (M1) contralateral to the side of worst LBP (Magstim 200 stimulator/7 cm figure-of-eight coil; Magstim Co. Ltd. Dyfed, UK). During testing the coil is positioned tangential to the skull and moved lateral to the midline. Using a stimulator intensity of 100%, with an inter-stimulus interval of ~5s, 5 stimuli are delivered over pre-marked scalp sites on a 6x7cm grid, commencing at the vertex. Surface electromyography (EMG) is recorded from the paraspinal muscles throughout. As paraspinal motor evoked potentials (MEPs) are difficult to elicit at rest, M1 stimulation is conducted during sub-maximal paraspinal muscle contractions. Target muscle activation is achieved by leaning backward into resistance provided from a pillow, whilst keeping the back straight. TMS map data are exported and analysed using MATLAB 7 (The MathWorks, USA). MEP responses are superimposed over the respective scalp sites to construct a topographical representation of the target paraspinal muscle and normalized to the peak response for each participant. Capacity for neuroplasticity: Brain derived neurotrophic factor (BDNF) genotyping: Cheek swabs taken on the day of baseline testing are used to prepare genomic DNA (Isohelix DNA Isolation Kit). Samples taken at T1 are immediately frozen at -80 oC and stored until analyses. Brain derived neurotrophic factor (BDNF) serum concentration: Peripheral venous blood is drawn into serum tubes (BD Vacutainer, SST II Advance) and clotted (30 min, room temperature) at T1. Serum is then separated by centrifugation (2500 rpm, 15 min) and stored separately at -80°C until measurement. BDNF serum concentration is measured using an enzyme-linked immunosorbent assay (ELISA). Psychological status: Pain catastrophising scale: The Pain Catastrophising Scale (PCS) is included to assess catastrophizing thoughts about pain. The PCS includes 13 items, scored on a 5-point scale. Depression, anxiety and stress scale: A 21-item version of the depression, anxiety and stress scales questionnaire (DASS-21) will be administered. The questionnaire includes three 7-item subscales: DASS-depression, DASS-anxiety, DASS-stress. A total score is obtained for the DASS-21 with higher scores indicating greater depression, anxiety and/or stress Pain self-efficacy questionnaire: The pain self-efficacy questionnaire consists of 10 items, each scored on a 7-point scale. The questionnaire evaluates the confidence of an individual in their ability to perform a range of functional activities whilst in pain. A total score between 0 to 60 is calculated, with higher scores representing greater self-efficacy beliefs Demographics and baseline pain intensity; Age, sex and previous history of low back pain data will be collected from all participants at baseline. Baseline pain intensity will be drawn from the Brief Pain Inventory administered at T1 (as described under primary outcome measure 1) where participants score their pain intensity on average over the previous week using the NRS.
Sponsors
Neuroscience Research Australia
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Eligible participants must be 18 years or older and currently experiencing acute non-specific low back pain - defined as pain in the region of the lower back, superiorly bound by the thoracolumbar junction and inferiorly by the gluteal fold. Participants remain eligible if they have pain referred beyond this region that is not suspected radicular pain from neural tissue involvement. Pain must have been present for more than 24 hours and less than 6 weeks duration following a period of at least 1-month pain-free. As we aim to determine which variables predict low back pain outcome, regardless of whether this is the first episode of pain, participants need not be experiencing their first low back pain episode. Previous history of low back pain will be included as a candidate predictor in the statistical model. Participants must provide written informed consent to participate and be able to speak and read English.
Exclusion criteria
Known or suspected serious spinal pathology (fracture; malignancy, inflammatory or infective diseases of the spine; cauda equina syndrome or widespread neurological disorder); suspected or confirmed pregnancy or less than six months’ post-partum; suspected radicular pain (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); previous lumbar spinal surgery (e.g. spinal fusion, intervertebral disc replacement); presence of another painful condition (e.g. fibromyalgia, neuropathy, rheumatoid arthritis); comorbidities affecting sensorimotor function or causing neurological deficit (e.g. multiple sclerosis, spinal cord injury); history of psychological disorders requiring medication for symptom control (e.g. major depressive disorder, bipolar disorder, schizophrenia) and/or contraindications to transcranial magnetic stimulation.
Outcome results
None listed