- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00201513
Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain
October 8, 2012 updated by: Norwegian University of Science and Technology
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
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
-
-
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Trondheim, Norway, 7489
- Norwegian University of Science and Technology, National center for spinal diseases
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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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: TrA exercise
Isolated Transversus abdominis (TrA) exercises (low load)
|
Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
|
Experimental: sling exercise
Sling exercises (high load)
|
Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
|
Active Comparator: group exercise
Non-specific group exercises
|
Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle activity onset in transversus abdominal muscle
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain
Time Frame: 2 years
|
2 years
|
Function (Oswestry v2)
Time Frame: 2 years
|
2 years
|
Fear of avoidance belief
Time Frame: 1 year
|
1 year
|
Assessment of isolated transversus abd. and multifidus control
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ottar Vasseljen, PhD, National center for spinal diseases
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Vasseljen 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.
- Vasseljen 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.
- Unsgaard-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.
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
January 1, 2006
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
October 1, 2008
Study Registration Dates
First Submitted
September 16, 2005
First Submitted That Met QC Criteria
September 16, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
October 10, 2012
Last Update Submitted That Met QC Criteria
October 8, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK 4.2005.1720
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.
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