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NCT02422693 Clinical Trial

Aquatic Exercises for Patients With Chronic Low Back Pain

Chronic Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02422693
Other study ID # # 04/2012
Secondary ID
Status Completed
Phase N/A
First received April 6, 2015
Last updated July 5, 2017
Start date June 29, 2015
Est. completion date May 10, 2017

Study information
Verified date July 2017
Source Universidade Estadual de Londrina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date May 10, 2017
Est. primary completion date January 29, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Central nervous system disease

- Pregnant

- Fear of water

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Aquatic Exercises
Exercises performed in the water.
• Deep-water running
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

Locations
Country Name City State
Brazil Aquatic Physical Therapy Center "Paulo A. Seibert" Londrina Paraná

Sponsors (3)
Lead Sponsor Collaborator
Universidade Estadual de Londrina Fundação Araucária, Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Roland-Morris Questionnaire Functionality baseline and 9 weeks
Secondary Change in Pain status Pain baseline and 9 weeks
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