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

A randomised controlled trial investigating the effectiveness of two treatment programs at reducing pain intensity for people with chronic non-specific low back pain

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000610538
Acronym
RESOLVE
Enrollment
275
Registered
2015-06-11
Start date
2015-12-14
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

Interventions

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 we

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

Sponsors

Dr James McAuley
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 18, 2026