Clinical Trial Details

The RESOLVE Trial: Retraining the brain to reduce pain intensity of chronic low back pain

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Trial Information

Broad Health Condition Musculoskeletal
Neurological

Specific Health ConditionOther muscular and skeletal disorders
Other neurological disorders

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW

Anticipated date of first participant enrolment14/12/2015

Anticipated date of last participant enrolment14/12/2015

Phase of TrialNot Applicable

Has the study received ethics approval?Further information iconApproved

Trial summary

The primary concern of people with chronic low back pain (CLBP) is pain relief, for which current treatments are not very effective. Our current understanding of pain and CLBP indicates that we should target the central nervous system in new treatment approaches. This project will test two new treatment approaches that target the central nervous system as part of the treatment of chronic low back pain. We predict that one of the new treatment approaches will result in a clinically meaningful reduction in pain intensity at six weeks post intervention
Eligibility

Key inclusion criteria

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

Minimum age18 Years

Maximum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key exclusion criteria

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
Contact details and further information

Sponsor Primary Sponsor Type: Individual
Primary Sponsor Name: Dr James McAuley
Primary Sponsor Address: Neuroscience Research Australia Barker St Randwick Sydney NSW 2031
Primary Sponsor Country: Australia

Trial websitehttp://neura.edu.au/resolve

Trial IDACTRN12615000610538

Contact person for information and recruitmentDr
James McAuley
Neuroscience Research Australia PO Box 1165 Randwick Sydney NSW 2031
+61 2 9399 1266

Further information iconJ.McAuley@neura.edu.au
Australia