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

Sponsor

University of Nove de Julho (Other)

Overall Status

Unknown status

CT.gov ID

NCT02056197

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: Placebo Other: Stable surface exercises Other: Unstable surface exercises	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Shortwave 30 minutes.	Other: Placebo Shortwave
Active Comparator: Stable Stable surface exercises	Other: Stable surface exercises Stable surface exercises
Experimental: Unstable Unstable surface exercises	Other: Unstable surface exercises

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Shortwave 30 minutes.

Other: Placebo

Shortwave

Active Comparator: Stable

Stable surface exercises

Other: Stable surface exercises

Stable surface exercises

Experimental: Unstable

Unstable surface exercises

Other: Unstable surface exercises

Outcome Measures

Primary Outcome Measures

Pain Scores on the Visual Analog Scale [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Nove de Julho	São Paulo		Brazil	02117-020

Sponsors and Collaborators

University of Nove de Julho

Investigators

Study Chair: Paulo RG Lucareli, PhD, University of Nove de Julho

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Paulo Roberto Garcia Lucareli, Professor, University of Nove de Julho

ClinicalTrials.gov Identifier:

NCT02056197

Other Study ID Numbers:

PL002

First Posted:

Feb 5, 2014

Last Update Posted:

Feb 5, 2014

Last Verified:

Jan 1, 2014

Additional relevant MeSH terms:

Back Pain

Low Back Pain

Study Results

No Results Posted as of Feb 5, 2014