- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00864422
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain
March 17, 2009 updated by: The University of Queensland
Driving Plasticity in the Motor Brain in Chronic Back Pain
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Queensland
-
Brisbane, Queensland, Australia, 4072
- Centre for Clinical Research Excellence in Spinal Pain, Injury and Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
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.
|
Active Comparator: 2
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor cortical map and excitability from transcranial magnetic stimulation
Time Frame: Pre and 2 weeks post-intervention
|
Pre and 2 weeks post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor activation of the abdominal muscles during functional arm movement task
Time Frame: Pre and 2 weeks post-intervention
|
Pre and 2 weeks post-intervention
|
Self-reported pain (VAS scale) and functional scale (patient-specific functional scale)
Time Frame: Pre and 2 weeks post-intervention
|
Pre and 2 weeks post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paul W Hodges, MedDr (Neurosci) PhD BPhty, The University of Queensland
- Principal Investigator: Henry Tsao, PhD MPhty (Manipulative) BPhty, The University of Queensland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
March 17, 2009
First Submitted That Met QC Criteria
March 17, 2009
First Posted (Estimate)
March 18, 2009
Study Record Updates
Last Update Posted (Estimate)
March 18, 2009
Last Update Submitted That Met QC Criteria
March 17, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NHMRC-ID351656
- NHMRC-ID401599
- PRF-007/06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Low Back Pain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Iran University of Medical SciencesNot yet recruitingLow Back Pain | Chronic Low-back Pain | Chronic Non-specific Low Back Pain | Cupping Therapy
-
Federal University of Minas GeraisRecruitingBack Pain | Low Back Pain | Chronic Low-back Pain | Back Pain Lower Back ChronicBrazil
-
Federal University of ParaíbaCompletedChronic Low Back Pain | Nonspecific Chronic Low Back Pain
-
Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
-
University of Colorado, BoulderNational Institutes of Health (NIH); Radiological Society of North America; Psychophysiologic... and other collaboratorsCompletedChronic Pain | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Presidio Medical, IncRecruitingChronic Pain | Chronic Low-back PainAustralia
-
University of WashingtonNational Center for Complementary and Integrative Health (NCCIH)Active, not recruiting
-
Dan RhonNational Center for Complementary and Integrative Health (NCCIH); 59th Medical... and other collaboratorsRecruitingLow Back Pain | Chronic Pain | Surgery | Back Pain Lower Back Chronic | Back Pain, LowUnited States
-
Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
Clinical Trials on Skilled motor training
-
University GhentFund for Scientific Research, Flanders, BelgiumRecruitingLow Back Pain, RecurrentBelgium
-
University Ramon LlullAinhoa Nieto Guisado; Mònica Solana-TramuntUnknownCognitive Change | Proprioception Change | Balance ChangeSpain
-
University of California, San DiegoCompletedAutism Spectrum Disorder | Autistic DisorderUnited States
-
University of PlymouthRecruiting
-
Ahmed Mahmoud KadryConcordia University WisconsinCompleted
-
Walsh UniversityCompletedDizziness | ConcussionUnited States
-
Clare MaguireRehab Basel; Bildungszetrum Gesundheit Basel-StadtCompleted
-
National Taiwan University HospitalNational Science and Technology Council, TaiwanNot yet recruitingChronic StrokeTaiwan
-
Riphah International UniversityRecruiting
-
VA Office of Research and DevelopmentCompletedSpinal Cord Injuries | Paraparesis | ParaplegiaUnited States