None listed
Conditions
Brief summary
Chronic low back pain (LBP), that is LBP that has persisted for longer than 3 months, is a growing health burden. One factor that contributes to the burden of low back pain is that the improvements in symptoms that effective treatments provide are not sustained over time. Effective treatments for LBP are becoming increasing complex. There is need to develop and test interventions aimed at maintaining the initial improvements from complex interventions. One way to maintain improvements from complex interventions is by implementing booster interventions. The aim of a booster session is to maintain improvements in symptoms by reinforcing the training components of the intervention. The RESOLVE will provide platform to test the feasibility of a booster intervention. The RESOLVE trial assesses the effectiveness of two complex treatment programs that combine central nervous system-directed and traditional interventions to promote recovery in participants with chronic LBP (the protocol is described elsewhere). One method to sustain any benefits achieved as a result of such a complex treatment intervention, such as in the RESOLVE trial, is to include a booster session.
Interventions
The booster trial is designed to investigate the feasibility of developing a booster intervention. The goal of a booster intervention is to maintain any improvement in symptoms achieved as part of the primary trial.
The booster intervention will supplement the treatment provided as part of the RESOLVE trial.
The booster session will be delivered between 36-42 weeks from baseline of the RESOLVE trial. The session will last 30-60 minutes. It will be conducted in the same setting as the RESOLVE t
The booster trial is designed to investigate the feasibility of developing a booster intervention. The goal of a booster intervention is to maintain any improvement in symptoms achieved as part of the primary trial. The booster intervention will supplement the treatment provided as part of the RESOLVE trial. The booster session will be delivered between 36-42 weeks from baseline of the RESOLVE trial. The session will last 30-60 minutes. It will be conducted in the same setting as the RESOLVE trial. The booster session will revisit the same treatment interventions introduced during the RESOLVE trial. No new content will be raised during the booster session. The booster session will be tailored to each participant and could focus on any element of the RESOLVE trial. The RESOLVE trial interventions include; Discussion of the low back pain experience - delivered over twelve weeks Laterality recognition training - delivered over eleven weeks - involves distinguishing between images of trunks rotated to left or right using Recognise (NOIgroup) software package Tactile acuity training - delivered over ten weeks - involves localising and/or discriminating between different types of non-noxious tactile stimuli or multiple simultaneous non-noxious tactile stimuli applied by the therapist to the lower back. Motor Imagery - delivered over ten weeks - involves mental visualisation of movements of the lower back and lower limbs, with or without videos Feedback enhanced functional movement training - delivered over seven weeks - involves graded, individualised training of functional movement patterns with mirror visual feedback Discussion of the low back pain experience - delivered over twelve weeks Transcranial direct current stimulation (tDCS) - delivered over eleven weeks - involves application of tDCS whilst comfortably seated for 10-20mins Cranial electrical stimulation - delivered over eight weeks - involves application of CES whilst comfortably seated for 30mins Low-intensity laser therapy - delivered over ten weeks - involves application of low-intensity laser to the lower back whilst lying comfortably Pulsed electromagnetic energy - delivered over seven weeks - involves application of pulsed electromagnetic energy to the lower back whilst lying comfortably Where possible the same researcher who delivered the RESOLVE intervention will deliver the booster session to that participant. The researchers involved in delivering the RESOLVE intervention have physiotherapy or exercise physiology qualifications. Participants allocated to the control arm of the booster trial will not receive a booster session. As part of the RESOLVE trial we will collect data on all participants at 18 weeks and 52 weeks post randomisation. The researchers will follow a protocol for the intervention to ensure fidelity. The researcher will log data specific to the booster session to maintain fidelity such as time spent on booster session, perceived benefit of booster session.
Sponsors
Associate Professor James McAuley
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(As per RESOLVE trial) Participation in the RESOLVE trial Primary complaint of pain in the area between the 12th rib and buttock crease with or without accompanying leg pain Low back pain of at least 12 weeks duration Mean pain intensity Numerical Rating Scale (NRS) greater than or equal to 3/10 in the past week Sufficient fluency in English language to understand and respond to English language questionnaires and to engage with the intervention Partner (friend or spouse) who is able to assist with home component of intervention Internet access Age 18-70, inclusive
Exclusion criteria
(As per RESOLVE trial) Known or suspected serious spinal pathology (fracture; malignant, 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 Nerve root compromise (any two of altered strength, reflex or sensation for the same nerve root) Spinal surgery less than twelve months previously Scheduled for major surgery during the treatment or follow-up period Any of the contraindications to exercise listed in the American College of Sports Medicine guidelines Uncontrolled mental health condition (eg, schizophrenia, bipolar disorder, major depressive disorder) that precludes successful participation Any of the contra-indications to electrotherapeutic agents
Outcome results
None listed