Plus Deep Water Running on Low Back Pain (+DWR)

April 24, 2009 updated by: University of Malaga

Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial

Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.

Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Malaga, Spain
        • School Medicine University of Malaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months

Exclusion Criteria:

  • Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
  • Patients not able to follow instructions
  • Patients with any digressive condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: General Practice (GP) in Physio plus Deep water running
A supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test
Procedure: GP in Physio plus DWR
GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
Experimental: General Practice in Physio
A procedure of evidence-based physiotherapy is usual care in pragmatic trial
Procedure: GP in Physio
manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain in VAS
Time Frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
scale 0 -100, pre and post intervention and follow up 6 and 12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
disability RMQ
Time Frame: scale 0-24, pre and post intervention and follow up 6 and 12 month
scale 0-24, pre and post intervention and follow up 6 and 12 month
general (mental and physical) health state with SF-12
Time Frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
scale 0 -100, pre and post intervention and follow up 6 and 12 month
functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)
Time Frame: scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Investigators

  • Principal Investigator: Antonio Cuesta-Vargas, PhD, University of Malaga

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

April 24, 2009

First Posted (Estimate)

April 27, 2009

Study Record Updates

Last Update Posted (Estimate)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 857 IAC 0630041300

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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