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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00888524
Recruitment Status : Completed
First Posted : April 27, 2009
Last Update Posted : April 27, 2009
Information provided by:
University of Malaga

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: GP in Physio Procedure: GP in Physio plus DWR Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
Study Start Date : January 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. pain in VAS [ Time Frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month ]

Secondary Outcome Measures :
  1. disability RMQ [ Time Frame: scale 0-24, pre and post intervention and follow up 6 and 12 month ]
  2. 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 ]
  3. 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 ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00888524

School Medicine University of Malaga
Malaga, Spain
Sponsors and Collaborators
University of Malaga
Principal Investigator: Antonio Cuesta-Vargas, PhD University of Malaga

Additional Information:
Responsible Party: Jose Angel Narvaez Bueno, Vice_chancelor of Universoty of Malaga, research Identifier: NCT00888524     History of Changes
Other Study ID Numbers: 857 IAC 0630041300
857 IAC 0630041300
First Posted: April 27, 2009    Key Record Dates
Last Update Posted: April 27, 2009
Last Verified: April 2009

Keywords provided by University of Malaga:
head out water immersion,
high intensity exercise,
evidence-based physiotherapy;
aquatics therapy
exercise therapy

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms