- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214213
Non-Specific Chronic Back Pain; Insight From Spatial Aspects of Lumbar Spinal Muscle Activation
September 26, 2016 updated by: Inge Ringheim, Oslo University Hospital
NON-SPECIFIC CHRONIC BACK PAIN; INSIGHT FROM SPATIAL ASPECTS OF LUMBAR SPINAL MUSCLE ACTIVATION
There is evidence for altered muscle activity patterns in individuals with non-specific chronic back pain (NSCBP).
It is unknown why these alterations in activation pattern occur and how they may be linked to pain experience and to the development of CNSBP.
The main objective of this study is to investigate the spatial aspects of muscle activation in relation to fatigue/endurance and CNSBP.
A novel approach, utilizing a new multi-channel surface-EMG (MCsEMG) technique will be applied in this project to get insight in fundamental mechanisms related to motor control and fatigue/endurance.
In this project data from healthy persons and from patients with NSCBP will be collected and analyzed.
NSCBP patients will be compared to healthy persons.
To minimize heterogeneity between groups the subject's age range will be from 30 - 50 years.
The investigators main hypothesis is that motor control mechanisms of the lumbar muscles are disturbed in NSCBP patients compared to normals, explaining the reduced tolerance for static postures.
There has been little investigation of the lumbar musculature with MCsEMG recordings.
The lumbar musculature has a complex organization; many, relatively small muscles, in a restricted area.
Utilizing two HDsEMG grids with 252 Ag/AgCl contacts will be the superior non-invasive method to investigate motor control mechanisms in this region, and further the investigators understanding of neuromuscular adaptations related to NSCBP.
The project may demonstrate changes that will lead us to new insight and new strategies for the treatment of back pain.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
57
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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Stavern, Norway, 3291
- Vestfold Hospital Trust, Kysthospitalet
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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
30 years to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chronic non-spesific low back pain and healthy control subjects
Description
Inclusion Criteria:
- patients
- diagnosed with chronic NSCBP >3 months duration
- healthy controls
- no back pain.
Exclusively exclusion criteria for this group will be back pain in the previous year or back pain lasting longer than one week in previous 3 years.
Exclusion Criteria:
- anamnesis of medical or drug abuse
- surgery on the musculoskeletal system of the trunk
- known congenital malformation of the spine or scoliosis
- body mass index >27 kg/m2
- systemic-neurological-degenerative disease
- history of stroke
- psychiatric disorder
- pregnancy and abnormal blood pressure.
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Aage Indahl, Phd
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
September 1, 2009
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
October 1, 2010
First Submitted That Met QC Criteria
October 1, 2010
First Posted (Estimate)
October 4, 2010
Study Record Updates
Last Update Posted (Estimate)
September 27, 2016
Last Update Submitted That Met QC Criteria
September 26, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MULTI2009
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.