Influence of an Exercise for Trunk Stabilization Performe... | NCT02056197

Studies
Influence of an Exercise for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain.

NCT02056197

Sponsor

University of Nove de Julho

Status

Unknown status

Last Update Posted

Feb 5, 2014Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Low Back Pain

Interventions

Placebo
Stable surface exercises
Unstable surface exercises

Countries

Brazil

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

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2013

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Jan 28, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

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

Feb 4, 2014

Last Update Posted Date

Feb 5, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Paulo Roberto Garcia Lucareli, Professor, University of Nove de JulhoPrincipal Investigator

Lead Sponsor

University of Nove de JulhoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Motor control exercises have demonstrated a good option for recovery from chronic low back pain. The purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (NCLBP). Patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface.

We hypothesized the unstable group will present pain reduction and functional improvement.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Shortwave 30 minutes.	Other: Placebo
Stable	Active Comparator	Stable surface exercises	Other: Stable surface exercises
Unstable	Experimental	Unstable surface exercises	Other: Unstable surface exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Other	Shortwave	Placebo
Stable surface exercises

Measure	Description	Time Frame
Pain Scores on the Visual Analog Scale		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Non-specific low back pain
Sedentary
Previous low back pain last 6 months

Exclusion Criteria:

Traumatic, inflammatory, infectious or tumours etiology
Positive neurological findings (leg pain)
Pregnancy
Previous spine or lower limb surgery
Contraindicated for short-waves aplication

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
André S Bley, MS	Contact	+5511995216393

Overall Officials

Name	Affiliation	Role
Paulo RG Lucareli, PhD	University of Nove de Julho	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universidade Nove de Julho	Recruiting	São Paulo	São Paulo	02117-020	Brazil

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