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Changes in Motor Cortex Following Exercises for Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Skilled motor training
Walking exercise
Sponsored by
The University of Queensland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Low Back Pain focused on measuring low back pain, motor training, motor cortex, brain plasticity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Clinical Research Excellence in Spinal Pain, Injury and Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Motor cortical map and excitability from transcranial magnetic stimulation

Secondary Outcome Measures

Motor activation of the abdominal muscles during functional arm movement task
Self-reported pain (VAS scale) and functional scale (patient-specific functional scale)

Full Information

First Posted
March 17, 2009
Last Updated
March 17, 2009
Sponsor
The University of Queensland
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1. Study Identification

Unique Protocol Identification Number
NCT00864422
Brief Title
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain
Official Title
Driving Plasticity in the Motor Brain in Chronic Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Queensland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, motor training, motor cortex, brain plasticity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Skilled motor training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Walking exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Motor cortical map and excitability from transcranial magnetic stimulation
Time Frame
Pre and 2 weeks post-intervention
Secondary Outcome Measure Information:
Title
Motor activation of the abdominal muscles during functional arm movement task
Time Frame
Pre and 2 weeks post-intervention
Title
Self-reported pain (VAS scale) and functional scale (patient-specific functional scale)
Time Frame
Pre and 2 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul W Hodges, MedDr (Neurosci) PhD BPhty
Organizational Affiliation
The University of Queensland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Henry Tsao, PhD MPhty (Manipulative) BPhty
Organizational Affiliation
The University of Queensland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Clinical Research Excellence in Spinal Pain, Injury and Health
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4072
Country
Australia

12. IPD Sharing Statement

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Changes in Motor Cortex Following Exercises for Chronic Low Back Pain

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