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

This study has been completed.
Sponsor:
Information provided by:
University of Malaga
ClinicalTrials.gov Identifier:
NCT00888524
First received: April 22, 2009
Last updated: April 24, 2009
Last verified: April 2009
History of Changes
  Purpose

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 Intervention
Low Back Pain
 Procedure: GP in Physio
Procedure: GP in Physio plus DWR

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Malaga:

Primary Outcome Measures:
  • pain in VAS [ Time Frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • disability RMQ [ Time Frame: scale 0-24, pre and post intervention and follow up 6 and 12 month ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 46
Study Start Date: January 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00888524

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

Additional Information:
University of Malaga  This link exits the ClinicalTrials.gov site
Research And Development of Spain  This link exits the ClinicalTrials.gov site
Food and Drugs Administration  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Jose Angel Narvaez Bueno, Vice_chancelor of Universoty of Malaga, research
ClinicalTrials.gov Identifier: NCT00888524     History of Changes
Other Study ID Numbers: 857 IAC 0630041300, 857 IAC 0630041300
Study First Received: April 22, 2009
Last Updated: April 24, 2009
Health Authority: Spain: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013