Low Back PainNCT00555802
The Effect of Motor Control Exercise Versus General Exercise on Lumbar Local Stabilizing Muscles Thickness
A study testing exercise in people with Low Back Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The purpose of this study was to evaluate the efficacy of motor control exercises. For this, before and after motor control and general exercises, we determined transverses abdominis and multifidus thickness, activity limitation and pain. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- exercise
- How many people
- 49 participants
- Where
- 1 siteIran
- Study dates
- Apr 2006to Nov 2007
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nonspecific low back pain with or without leg pain of at least 3 months duration
- currently seeking care for low back pain
- aged greater than 18 and less than 80 years
- suitable for motor control exercise based on clinical assessment
- The patients must also have sufficient knowledge of the Persian language to understand instructions
Who cannot join
- suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome, widespread neurological disorder)
- suspected or confirmed pregnancy
- nerve root compromise (2 of strength, reflex or sensation affected for same nerve root)
- spinal surgery
- any of the contraindications to exercise listed on page 42 of the ACSM guidelines
Trial locations and contacts
1 site in 1 country.
Iran1 site
Dept. of physiotherapy, Zahedan university of medical scinces
Zahedan, Sistan & Bladchestan
About this study
The purpose of this study was to evaluate the efficacy of motor control exercises. For this, before and after motor control and general exercises, we determined transverses abdominis and multifidus thickness, activity limitation and pain. We hypothesized that the motor control exercises would increase transverses abdominis and multifidus muscles thickness. Activity limitation and pain would decrease following two protocols that it was more in motor control group than general one.
Read the detailed description
Musculoskeletal disorders, of which back pain accounts for more than half the number of cases, are the most common cause of chronic incapacity in industrialized countries. Approximately 10-20 percent of patients with low back pain develop chronic pain, defined as low back pain persisting more than 3 months. Low back pain represents a particularly costly sociomedical problem because of the expenditure associated with repeated treatment and the long-term absence from work and need for social support. These patients use more than 80% of health care resources for back problems, and treatment has a low success rate. Thus, the development of effective interventions aimed at management of the chronic problems is urgently required.
Review of studies showed that the effectiveness of stabilization exercises in patients with nonspecific LBP is not yet fully established. In clinical trials that improvement reported after motor control exercise, other intervention accompanied with these exercises. Also, the results of motor control exercise studies are different. On the other hand, the evidence underpins the primary aim of motor control exercise, which is to re-establish normal control of the deep spinal muscles, reducing the activity of more superficial muscles that tend to stiffen the spine and have increased activity in low back pain, and then maintain normal control during progressively more demanding physical and functional tasks. For these reasons, we decided to identify the efficacy of motor control exercises, usually considered as specific trunk muscle stabilization exercises. A randomized controlled trial was only way for identifying the role of these exercises in treating chronic low back pain. Also, our choice coincides with the research agenda set by the 2004 European Guideline.
- Conditions
- Low Back Pain
- Being tested
- exercise
- Keywords
- Low Back Pain, Motor Control Exercise, General exercise, Ultrasonography, Multifidus, Transversus abdominis, Randomized Controlled trial.
- 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.
exerciseOther
Also called training
exercise
What is being measured
The primary outcome is the main question the study is designed to answer.
Before and after intervention, we assessed the multifidus and abdominal muscles thickness (mm) using a 7.5 MHz B-mode transducer ultrasound, pain through visual analog scale and activity limitation through Back Performance Scale.
Measured: Baseline, 16 weeks
Secondary outcomes (1)
Weight, Age, height,BMI,Current duration of pain,Time since first onset
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startApr 2006
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Asghar Akbari, Principal investigator, Deputy of research, Zahedan university of medical scinces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555802
- Sponsor's protocol ID
- 86-1534
- Status last verified
- Nov 2007
- First submitted
- 8 Nov 2007
- Last updated
- 29 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Maher CG, Latimer J, Hodges PW, Refshauge KM, Moseley GL, Herbert RD, Costa LO, McAuley J. The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606]. BMC Musculoskelet Disord. 2005 Nov 4;6:54. doi: 10.1186/1471-2474-6-54.
PubMed 16271149
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motor Control Exercise Versus General Exercise on Lumbar Local Stabilizing Muscles Thickness
- ClinicalTrials.gov ID
- NCT00555802
- Acronym / sponsor ID
- 86-1534
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain, Motor Control Exercise, General exercise, Ultrasonography, Multifidus, Transversus abdominis, Randomized Controlled trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2006
- Study completion
- Nov 2007 (actual)
- First posted
- 9 Nov 2007 (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 purpose of this study was to evaluate the efficacy of motor control exercises. For this, before and after motor control and general exercises, we determined transverses abdominis and multifidus thickness, activity limitation and pain. We hypothesized that the motor control exercises would increase transverses abdominis and multifidus muscles thickness. Activity limitation and pain would decrease following two protocols that it was more in motor control group than general one.
Detailed description
Musculoskeletal disorders, of which back pain accounts for more than half the number of cases, are the most common cause of chronic incapacity in industrialized countries. Approximately 10-20 percent of patients with low back pain develop chronic pain, defined as low back pain persisting more than 3 months. Low back pain represents a particularly costly sociomedical problem because of the expenditure associated with repeated treatment and the long-term absence from work and need for social support. These patients use more than 80% of health care resources for back problems, and treatment has a low success rate. Thus, the development of effective interventions aimed at management of the chronic problems is urgently required.
Review of studies showed that the effectiveness of stabilization exercises in patients with nonspecific LBP is not yet fully established. In clinical trials that improvement reported after motor control exercise, other intervention accompanied with these exercises. Also, the results of motor control exercise studies are different. On the other hand, the evidence underpins the primary aim of motor control exercise, which is to re-establish normal control of the deep spinal muscles, reducing the activity of more superficial muscles that tend to stiffen the spine and have increased activity in low back pain, and then maintain normal control during progressively more demanding physical and functional tasks. For these reasons, we decided to identify the efficacy of motor control exercises, usually considered as specific trunk muscle stabilization exercises. A randomized controlled trial was only way for identifying the role of these exercises in treating chronic low back pain. Also, our choice coincides with the research agenda set by the 2004 European Guideline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- nonspecific low back pain with or without leg pain of at least 3 months duration
- currently seeking care for low back pain
- aged greater than 18 and less than 80 years
- suitable for motor control exercise based on clinical assessment
- The patients must also have sufficient knowledge of the Persian language to understand instructions
Key exclusion criteria (5 listed)
- suspected or confirmed serious spinal pathology (fracture, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome, widespread neurological disorder)
- suspected or confirmed pregnancy
- nerve root compromise (2 of strength, reflex or sensation affected for same nerve root)
- spinal surgery
- any of the contraindications to exercise listed on page 42 of the ACSM guidelines
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 |
|---|---|---|
| exerciseAlso: trainingexercise | Other | – |
Primary outcome
Before and after intervention, we assessed the multifidus and abdominal muscles thickness (mm) using a 7.5 MHz B-mode transducer ultrasound, pain through visual analog scale and activity limitation through Back Performance Scale.
Time frame: Baseline, 16 weeks
1 secondary outcome
Weight, Age, height,BMI,Current duration of pain,Time since first onset
Time frame: baseline
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 29 Jan 2008.
- Background: PubMed 16271149Maher CG, Latimer J, Hodges PW, Refshauge KM, Moseley GL, Herbert RD, Costa LO, McAuley J. The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606]. BMC Musculoskelet Disord. 2005 Nov 4;6:54. doi: 10.1186/1471-2474-6-54.
- Spine-health.com has organized its peer-reviewed articles and patient information into Health Hubs dedicated to specific conditions, treatments, and pain management topics.Link provided by the sponsor.
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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.
Asghar Akbari principal investigator
Deputy of research, Zahedan university of medical scinces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Low Back Pain, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 5 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 29 Jan 2008. 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 Iran. 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.
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?
Before and after intervention, we assessed the multifidus and abdominal muscles thickness (mm) using a 7.5 MHz B-mode transducer ultrasound, pain through visual analog scale and activity limitation through Back Performance Scale. (time frame: Baseline, 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555802, which also lists 1 linked publication.
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 29 Jan 2008.