Chronic Low Back PainPhase 1NCT00864422
Changes in Motor Cortex Following Exercises for Chronic Low Back Pain
A Phase 1 study testing Skilled motor training and Walking exercise in people with Chronic Low Back Pain, run by The University of Queensland at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Skilled motor training and Walking exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2006to Sep 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sustained or episodic non-specific low back pain lasting longer than 3 months
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Centre for Clinical Research Excellence in Spinal Pain, Injury and Health
Brisbane, Queensland, 4072
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Being tested
- Skilled motor training, Walking exercise
- Keywords
- low back pain, motor training, motor cortex, brain plasticity
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skilled motor trainingBehavioural
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 exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Skilled motor training |
| 2 | Active comparator | Not described Receives: Behavioral: Walking exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor cortical map and excitability from transcranial magnetic stimulation
Measured: Pre and 2 weeks post-intervention
Secondary outcomes (2)
Motor activation of the abdominal muscles during functional arm movement task
Measured: Pre and 2 weeks post-intervention
Self-reported pain (VAS scale) and functional scale (patient-specific functional scale)
Measured: Pre and 2 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Investigators
- Paul W Hodges, MedDr (Neurosci) PhD BPhty, Study director, The University of QueenslandHenry Tsao, PhD MPhty (Manipulative) BPhty, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00864422
- Sponsor's protocol ID
- NHMRC-ID351656
- Other IDs
- NHMRC-ID401599, PRF-007/06
- Status last verified
- Mar 2009
- First submitted
- 17 Mar 2009
- Last updated
- 18 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Driving Plasticity in the Motor Brain in Chronic Back Pain
- ClinicalTrials.gov ID
- NCT00864422
- Acronym / sponsor ID
- NHMRC-ID351656
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, motor training, motor cortex, brain plasticity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 18 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Skilled motor training |
| 2 | Active comparator | Behavioral: Walking exercise |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Sustained or episodic non-specific low back pain lasting longer than 3 months
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skilled motor trainingThis 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. | Behavioural | 1 |
| Walking exerciseThe 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. | Behavioural | 2 |
Primary outcome
Motor cortical map and excitability from transcranial magnetic stimulation
Time frame: Pre and 2 weeks post-intervention
2 secondary outcomes
Motor activation of the abdominal muscles during functional arm movement task
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul W Hodges, MedDr (Neurosci) PhD BPhty study director
The University of Queensland
Henry Tsao, PhD MPhty (Manipulative) BPhty principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Skilled motor training and Walking exercise in people with Chronic Low Back Pain, run by The University of Queensland at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor cortical map and excitability from transcranial magnetic stimulation (time frame: Pre and 2 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2009.