Low Back PainNCT00201513
Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain
A study testing Isolated Transversus abdominis (TrA) exercise, sling exercise and group exercise in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Isolated Transversus abdominis (TrA) exercise, sling exercise and group exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2006to Oct 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Unspecific subacute, subacute remitting and chronic LBP
- Both sexes, 20-60 yrs of age
- LBP between 2-8 on a 11-pt numeric rating scale
Who cannot join
- Previous back surgery
- Sick listed more than one year
- Radiating pain below knee or motor deficits
- Systemic diseases and "red flags"
- Diagnosed psychiatric disease
- Ingoing insurance claim
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology, National center for spinal diseases
Trondheim, Trondheim, 7489
About this study
Official title: Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.
- Conditions
- Low Back Pain
- Being tested
- Isolated Transversus abdominis (TrA) exercise, sling exercise, group exercise
- Keywords
- Muscle, Skeletal, Neuromuscular control, Stability, Exercise, Anticipatory muscle control
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolated Transversus abdominis (TrA) exerciseBehavioural
Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
sling exerciseBehavioural
Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
group exerciseBehavioural
Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback
| Study group | Role | What they receive |
|---|---|---|
| TrA exercise | Experimental | Isolated Transversus abdominis (TrA) exercises (low load) Receives: Behavioral: Isolated Transversus abdominis (TrA) exercise |
| sling exercise | Experimental | Sling exercises (high load) Receives: Behavioral: sling exercise |
| group exercise | Active comparator | Non-specific group exercises Receives: Behavioral: group exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle activity onset in transversus abdominal muscle
Measured: 1 year
Secondary outcomes (4)
Pain
Measured: 2 years
Function (Oswestry v2)
Measured: 2 years
Fear of avoidance belief
Measured: 1 year
Assessment of isolated transversus abd. and multifidus control
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Ottar Vasseljen, PhD, Study chair, National center for spinal diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201513
- Sponsor's protocol ID
- REK 4.2005.1720
- Status last verified
- Oct 2012
- First submitted
- 16 Sep 2005
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Unsgaard-Tondel M, Fladmark AM, Salvesen O, Vasseljen O. Motor control exercises, sling exercises, and general exercises for patients with chronic low back pain: a randomized controlled trial with 1-year follow-up. Phys Ther. 2010 Oct;90(10):1426-40. doi: 10.2522/ptj.20090421. Epub 2010 Jul 29.
PubMed 20671099Vasseljen O, Fladmark AM. Abdominal muscle contraction thickness and function after specific and general exercises: a randomized controlled trial in chronic low back pain patients. Man Ther. 2010 Oct;15(5):482-9. doi: 10.1016/j.math.2010.04.004.
PubMed 20621545Vasseljen O, Unsgaard-Tondel M, Westad C, Mork PJ. Effect of core stability exercises on feed-forward activation of deep abdominal muscles in chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 Jun 1;37(13):1101-8. doi: 10.1097/BRS.0b013e318241377c.
PubMed 22146280Unsgaard-Tondel M, Lund Nilsen TI, Magnussen J, Vasseljen O. Is activation of transversus abdominis and obliquus internus abdominis associated with long-term changes in chronic low back pain? A prospective study with 1-year follow-up. Br J Sports Med. 2012 Aug;46(10):729-34. doi: 10.1136/bjsm.2011.085506. Epub 2011 Jul 26.
PubMed 21791459
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00201513
- Acronym / sponsor ID
- REK 4.2005.1720
- Conditions
- Low Back Pain
- Keywords
- Muscle, Skeletal, Neuromuscular control, Stability, Exercise, Anticipatory muscle control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (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.
Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TrA exercise | Experimental | Behavioral: Isolated Transversus abdominis (TrA) exerciseIsolated Transversus abdominis (TrA) exercises (low load) |
| sling exercise | Experimental | Behavioral: sling exerciseSling exercises (high load) |
| group exercise | Active comparator | Behavioral: group exerciseNon-specific group exercises |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Unspecific subacute, subacute remitting and chronic LBP
- Both sexes, 20-60 yrs of age
- LBP between 2-8 on a 11-pt numeric rating scale
Key exclusion criteria (7 listed)
- Previous back surgery
- Sick listed more than one year
- Radiating pain below knee or motor deficits
- Systemic diseases and "red flags"
- Diagnosed psychiatric disease
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 |
|---|---|---|
| Isolated Transversus abdominis (TrA) exerciseEight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback | Behavioural | TrA exercise |
| sling exerciseEight weeks sling(high load) exercise program; Isolated TrA control through biofeedback | Behavioural | sling exercise |
| group exerciseEight weeks non-specific group exercise program; Isolated TrA control through biofeedback | Behavioural | group exercise |
Primary outcome
Muscle activity onset in transversus abdominal muscle
Time frame: 1 year
4 secondary outcomes
Pain
Time frame: 2 years
Function (Oswestry v2)
Time frame: 2 years
Fear of avoidance belief
Time frame: 1 year
Assessment of isolated transversus abd. and multifidus control
Time frame: 1 year
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 10 Oct 2012.
- Results publication: PubMed 20671099Unsgaard-Tondel M, Fladmark AM, Salvesen O, Vasseljen O. Motor control exercises, sling exercises, and general exercises for patients with chronic low back pain: a randomized controlled trial with 1-year follow-up. Phys Ther. 2010 Oct;90(10):1426-40. doi: 10.2522/ptj.20090421. Epub 2010 Jul 29.
- Results publication: PubMed 20621545Vasseljen O, Fladmark AM. Abdominal muscle contraction thickness and function after specific and general exercises: a randomized controlled trial in chronic low back pain patients. Man Ther. 2010 Oct;15(5):482-9. doi: 10.1016/j.math.2010.04.004.
- Results publication: PubMed 22146280Vasseljen O, Unsgaard-Tondel M, Westad C, Mork PJ. Effect of core stability exercises on feed-forward activation of deep abdominal muscles in chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 Jun 1;37(13):1101-8. doi: 10.1097/BRS.0b013e318241377c.
- Derived from this study: PubMed 21791459Unsgaard-Tondel M, Lund Nilsen TI, Magnussen J, Vasseljen O. Is activation of transversus abdominis and obliquus internus abdominis associated with long-term changes in chronic low back pain? A prospective study with 1-year follow-up. Br J Sports Med. 2012 Aug;46(10):729-34. doi: 10.1136/bjsm.2011.085506. Epub 2011 Jul 26.
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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.
Ottar Vasseljen, PhD study chair
National center for spinal diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isolated Transversus abdominis (TrA) exercise, sling exercise and group exercise in people with Low Back Pain, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 7 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 10 Oct 2012. 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 Norway. 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?
Muscle activity onset in transversus abdominal muscle (time frame: 1 year). 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 NCT00201513, which also lists 4 linked publications.
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 10 Oct 2012.