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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
GP in Physio
GP in Physio plus DWR
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring head out water immersion,, high intensity exercise,, evidence-based physiotherapy;, aquatics;, hydrotherapy, aquatics therapy, exercise therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • School Medicine University of Malaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

General Practice (GP) in Physio plus Deep water running

General Practice in Physio

Arm Description

A supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test

A procedure of evidence-based physiotherapy is usual care in pragmatic trial

Outcomes

Primary Outcome Measures

pain in VAS

Secondary Outcome Measures

disability RMQ
general (mental and physical) health state with SF-12
functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)

Full Information

First Posted
April 22, 2009
Last Updated
April 24, 2009
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT00888524
Brief Title
Plus Deep Water Running on Low Back Pain
Acronym
+DWR
Official Title
Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Malaga

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
head out water immersion,, high intensity exercise,, evidence-based physiotherapy;, aquatics;, hydrotherapy, aquatics therapy, exercise therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Practice (GP) in Physio plus Deep water running
Arm Type
Experimental
Arm Description
A supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test
Arm Title
General Practice in Physio
Arm Type
Experimental
Arm Description
A procedure of evidence-based physiotherapy is usual care in pragmatic trial
Intervention Type
Procedure
Intervention Name(s)
GP in Physio
Intervention Description
manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment
Intervention Type
Procedure
Intervention Name(s)
GP in Physio plus DWR
Intervention Description
GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
Primary Outcome Measure Information:
Title
pain in VAS
Time Frame
scale 0 -100, pre and post intervention and follow up 6 and 12 month
Secondary Outcome Measure Information:
Title
disability RMQ
Time Frame
scale 0-24, pre and post intervention and follow up 6 and 12 month
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Cuesta-Vargas, PhD
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
School Medicine University of Malaga
City
Malaga
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.uma.es/
Description
University of Malaga
URL
http://www.plannacionalidi.es/plan-idi-public/
Description
Research And Development of Spain
URL
http://www.fda.gov/
Description
Food and Drugs Administration

Learn more about this trial

Plus Deep Water Running on Low Back Pain

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