Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00864422




Registration number
NCT00864422
Ethics application status
Date submitted
17/03/2009
Date registered
18/03/2009
Date last updated
18/03/2009

Titles & IDs
Public title
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain
Scientific title
Driving Plasticity in the Motor Brain in Chronic Back Pain
Secondary ID [1] 0 0
NHMRC-ID401599
Secondary ID [2] 0 0
NHMRC-ID351656
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Low Back Pain 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Skilled motor training
BEHAVIORAL - Walking exercise

Experimental: 1 -

Active comparator: 2 -


BEHAVIORAL: Skilled motor training
This involves training subjects to independently and cognitively activate the deep abdominal muscles, transversus abdominis, with minimal or no activity in other trunk muscles. The contraction is held for 10 seconds and subjects complete three blocks of ten contractions, twice per day for two weeks. This training protocol is commonly used clinically for people with chronic back pain.

BEHAVIORAL: Walking exercise
The control intervention involves walking exercises for ten minutes, twice per day. Subjects are advised to walk at their own pace with no instructions on activation of specific trunk muscles. The exercise is performed over two weeks.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Motor cortical map and excitability from transcranial magnetic stimulation
Timepoint [1] 0 0
Pre and 2 weeks post-intervention
Secondary outcome [1] 0 0
Motor activation of the abdominal muscles during functional arm movement task
Timepoint [1] 0 0
Pre and 2 weeks post-intervention
Secondary outcome [2] 0 0
Self-reported pain (VAS scale) and functional scale (patient-specific functional scale)
Timepoint [2] 0 0
Pre and 2 weeks post-intervention

Eligibility
Key inclusion criteria
* Sustained or episodic non-specific low back pain lasting longer than 3 months
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Orthopaedic, neurological, circulatory or respiratory conditions
* History or family history of epilepsy
* Recent or current pregnancies
* Previous surgery to the abdomen or back
* Abdominal or back exercises in the preceding 12 months

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Centre for Clinical Research Excellence in Spinal Pain, Injury and Health - Brisbane
Recruitment postcode(s) [1] 0 0
4072 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The motor cortex of the brain changes following chronic pain and injury, and this is linked to pain-associated changes in motor behaviour. This study aimed to investigate whether therapeutic exercises in patients with chronic pain can induce reorganisation of the motor cortex and restore normal motor behaviour. The investigators hypothesised that motor training can induce reorganisation of the motor cortex and that these changes are related to improved motor behaviour.
Trial website
https://clinicaltrials.gov/study/NCT00864422
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul W Hodges, MedDr (Neurosci) PhD BPhty
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00864422