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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00864422
Other study ID # NHMRC-ID351656
Secondary ID NHMRC-ID401599PR
Status Completed
Phase Phase 1
First received March 17, 2009
Last updated March 17, 2009
Start date October 2006
Est. completion date September 2007

Study information

Verified date March 2009
Source The University of Queensland
Contact n/a
Is FDA regulated No
Health authority Australia: National Health and Medical Research Council
Study type Interventional

Clinical Trial 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.


Description:

The sensory and motor systems can reorganize following injury and learning of new motor skills. Recently we observed adaptive changes in motor cortical organization in patients with chronic back pain, which are closely linked to changes in motor behavior. Although pain-related alterations in behavior can be trained and are associated with improved symptoms, it remains unclear whether these meaningful functional outcomes are related to motor cortical reorganization. Here we investigate the effects of two interventions in people with chronic back pain: skilled motor training and a control intervention of self-paced walking exercise. We measured motor cortical excitability (motor threshold (MT)) and organization (center of gravity (CoG) and map volume) of the deep abdominal muscle, transversus abdominis (TrA), using transcranial magnetic stimulation (TMS). In addition, motor behavior of TrA was assessed during single rapid arm movements. The study helps to elucidate the mechanisms of specific motor exercises in chronic back pain management.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2007
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria:

- Sustained or episodic non-specific low back pain lasting longer than 3 months

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Australia Centre for Clinical Research Excellence in Spinal Pain, Injury and Health Brisbane Queensland

Sponsors (1)

Lead Sponsor Collaborator
The University of Queensland

Country where clinical trial is conducted

Australia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Motor cortical map and excitability from transcranial magnetic stimulation Pre and 2 weeks post-intervention No
Secondary Motor activation of the abdominal muscles during functional arm movement task Pre and 2 weeks post-intervention No
Secondary Self-reported pain (VAS scale) and functional scale (patient-specific functional scale) Pre and 2 weeks post-intervention No
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