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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000610538
• Date of registration: 11/06/2015
• Prospective Registration: Yes
• Primary sponsor: Dr James McAuley
• Public title: The RESOLVE Trial: Retraining the brain to reduce pain intensity of chronic low back pain
• Scientific title: A randomised controlled trial investigating the effectiveness of two treatment programs at reducing pain intensity for people with chronic non-specific low back pain
• Date of first enrolment: 14/12/2015
• Target sample size: 275
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000610538.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr James McAuley

• Name: Dr James McAuley

Key inclusion & exclusion criteria

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
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

Age minimum: 18 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Neurological - Other neurological disorders

Musculoskeletal - Other muscular and skeletal disorders

Chronic Low Back Pain;
Chronic Low Back Pain

Intervention(s)

Twelve week treatment program delivered during one 60min session once per week. All treatment sessions are one-on-one. There is a home training component - 30mins 5x/week. The intervention comprises discussion of the low back pain experience, laterality recognition and tactile acuity training, motor imagery and feedback enhanced functional movement training. The treatments are not mutually exclusive and are likely to overlap.
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
Interventions will be monitored using an individual treatment diary

Primary Outcome(s)

Pain intensity (Numerical Rating Scale)[18 weeks post randomisation]

Secondary Outcome(s)

Global perceived effect[18 weeks post randomisation]

Disability (Roland Morris Disability Questionnaire)[18 weeks post randomisation]

Secondary ID(s)

nil

Source(s) of Monetary Support

National Health and Medical Research Council (NHMRC)

Ethics review

Status: Approved
Approval date:
Contact:

University of New South Wales Human Research Ethics Committee