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

Primary Purpose

Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Placebo

Stable surface exercises

Unstable surface exercises

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universidade Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Experimental

Arm Label

Placebo

Stable

Unstable

Arm Description

Shortwave 30 minutes.

Stable surface exercises

Unstable surface exercises

Outcomes

Primary Outcome Measures

Pain Scores on the Visual Analog Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT02056197

First Posted

January 28, 2014

Last Updated

February 4, 2014

Sponsor

University of Nove de Julho

1. Study Identification

Unique Protocol Identification Number

NCT02056197

Brief Title

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

Official Title

Influence of an Exercise Program for Trunk Stabilization Performed in Stable and Unstable Surfaces for Chronic Low Back Pain: Single-blind, Randomized Controlled Clinical Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Nove de Julho

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Shortwave 30 minutes.

Arm Title

Stable

Arm Type

Active Comparator

Arm Description

Stable surface exercises

Arm Title

Unstable

Arm Type

Experimental

Arm Description

Unstable surface exercises

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Shortwave

Intervention Type

Other

Intervention Name(s)

Stable surface exercises

Intervention Description

Stable surface exercises

Intervention Type

Other

Intervention Name(s)

Unstable surface exercises

Primary Outcome Measure Information:

Title

Pain Scores on the Visual Analog Scale

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

André S Bley, MS

Phone

+5511995216393

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo RG Lucareli, PhD

Organizational Affiliation

University of Nove de Julho

Official's Role

Study Chair

Facility Information:

Facility Name

Universidade Nove de Julho

City

São Paulo

ZIP/Postal Code

02117-020

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

André S Bley, MS

Phone

+5511995216393

andrebley@uninove.br

First Name & Middle Initial & Last Name & Degree

Paulo RG Lucareli, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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