Non-Specific Chronic Back Pain; Insight From Spatial Aspe... | NCT01214213

Studies
Non-Specific Chronic Back Pain; Insight From Spatial Aspects of Lumbar Spinal Muscle Activation

NCT01214213

Sponsor

Oslo University Hospital

Status

Completed

Last Update Posted

Sep 27, 2016Estimated

Enrollment

57Actual

Phase

Not provided

Conditions

Low Back Pain

Interventions

Not provided

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jan 2014Actual

Completion Date

Aug 2014Actual

First Submitted Date

Oct 1, 2010

First Submission Date that Met QC Criteria

Oct 1, 2010

First Posted Date

Oct 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2016

Last Update Posted Date

Sep 27, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Chronic non-spesific low back pain and healthy control subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aage Indahl, Phd		Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vestfold Hospital Trust, Kysthospitalet		Stavern		3291	Norway

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided