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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01214213
Other study ID # MULTI2009
Secondary ID
Status Completed
Phase Phase 1
First received October 1, 2010
Last updated September 26, 2016
Start date September 2009
Est. completion date August 2014

Study information

Verified date September 2016
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 57
Est. completion date August 2014
Est. primary completion date January 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 30 Years to 50 Years
Eligibility 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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Norway Vestfold Hospital Trust, Kysthospitalet Stavern

Sponsors (1)

Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

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