NCT01214213

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 1, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 4, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

October 1, 2010

Last Update Submit

September 26, 2016

Conditions

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Chronic non-spesific low back pain and healthy control subjects

You may qualify if:

  • patients
  • diagnosed with chronic NSCBP \>3 months duration
  • healthy controls
  • no back pain.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vestfold Hospital Trust, Kysthospitalet

Stavern, 3291, Norway

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Aage Indahl, Phd

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

October 1, 2010

First Posted

October 4, 2010

Study Start

September 1, 2009

Primary Completion

January 1, 2014

Study Completion

August 1, 2014

Last Updated

September 27, 2016

Record last verified: 2016-09

Locations