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Aquatic Exercises for Patients With Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Aquatic Exercises

Deep-water running

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring hydrotherapy, aquatic

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Exclusive diagnosis of chronic low back pain (more than 12 weeks)

Exclusion Criteria:

Central nervous system disease
Pregnant
Fear of water

Sites / Locations

Aquatic Physical Therapy Center "Paulo A. Seibert"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aquatic exercises

Aquatic exercises + Deep-water running

Arm Description

Warm-up, lumbar mobilization, stretching and relaxation. 3x-week (9 weeks), indoor pool, 32o.C/89.6o.F.

Same as AEG with addition of 20 minutes of running without touch the ground, 3x-week (9 weeks), indoor pool, 30o.C/86o.F.

Outcomes

Primary Outcome Measures

Change in Roland-Morris Questionnaire

Functionality

Secondary Outcome Measures

Change in Pain status

Pain

Full Information

NCT ID

NCT02422693

First Posted

April 6, 2015

Last Updated

July 5, 2017

Sponsor

Universidade Estadual de Londrina

Collaborators

Ministry of Health, Brazil, Fundação Araucária

1. Study Identification

Unique Protocol Identification Number

NCT02422693

Brief Title

Aquatic Exercises for Patients With Chronic Low Back Pain

Official Title

Aquatic Exercises Versus Aquatic Exercises Associated to Deep Water-running for Patients With Chronic Low Back Pain: Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

June 29, 2015 (Actual)

Primary Completion Date

January 29, 2017 (Actual)

Study Completion Date

May 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidade Estadual de Londrina

Collaborators

Ministry of Health, Brazil, Fundação Araucária

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to compare the effect of aquatic exercises (AEG) to the aquatic exercises plus aerobic training (deep-water running) (AEDWRG) on functional status and pain in patients with specific chronic low back pain.

Detailed Description

In general, the population will have at least one episode of low back pain during their lifetime, with recurrence in most cases. Several treatments have been proposed for these patients and the evidence is still not clear about the effectiveness of aquatic exercises when compared to other modalities of exercises in the water. This study will be a randomized controlled trial following the Consort-Statement principles. The subjects, aged between 20 and 50 years, after signing the informed consent will be randomly allocated to one group treatment: aquatic exercises (AEG) or aquatic exercises associated to deep-water running (AEDWRG). The duration of the protocol will be set at 12 weeks, 3x-week.

6. Conditions and Keywords

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

Chronic Low Back Pain

Keywords

hydrotherapy, aquatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Aquatic exercises

Arm Type

Experimental

Arm Description

Warm-up, lumbar mobilization, stretching and relaxation. 3x-week (9 weeks), indoor pool, 32o.C/89.6o.F.

Arm Title

Aquatic exercises + Deep-water running

Arm Type

Active Comparator

Arm Description

Same as AEG with addition of 20 minutes of running without touch the ground, 3x-week (9 weeks), indoor pool, 30o.C/86o.F.

Intervention Type

Other

Intervention Name(s)

Aquatic Exercises

Other Intervention Name(s)

Aquatic Physical Therapy

Intervention Description

Exercises performed in the water.

Intervention Type

Other

Intervention Name(s)

Deep-water running

Intervention Description

It is a non-impact form of running executed in place in (higher than 2 meters) the water wearing a flotation belt. Heart rate is controlled by heart rate watch

Primary Outcome Measure Information:

Title

Change in Roland-Morris Questionnaire

Description

Functionality

Time Frame

baseline and 9 weeks

Secondary Outcome Measure Information:

Title

Change in Pain status

Description

Pain

Time Frame

baseline and 9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Exclusive diagnosis of chronic low back pain (more than 12 weeks) Exclusion Criteria: Central nervous system disease Pregnant Fear of water

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jefferson R Cardoso, PT, PhD

Organizational Affiliation

Universidade Estadual de Londrina

Official's Role

Principal Investigator

Facility Information:

Facility Name

Aquatic Physical Therapy Center "Paulo A. Seibert"

City

Londrina

State/Province

Paraná

ZIP/Postal Code

86038440

Country

Brazil

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Aquatic Exercises for Patients With Chronic Low Back Pain

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