NCT00888524

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2009

Completed
Last Updated

April 27, 2009

Status Verified

April 1, 2009

Enrollment Period

1.7 years

First QC Date

April 22, 2009

Last Update Submit

April 24, 2009

Conditions

Low Back Pain

Keywords

head out water immersion,high intensity exercise,evidence-based physiotherapy;aquatics;hydrotherapyaquatics therapyexercise therapy

Outcome Measures

Primary Outcomes (1)

  • pain in VAS

    scale 0 -100, pre and post intervention and follow up 6 and 12 month

Secondary Outcomes (3)

  • disability RMQ

    scale 0-24, pre and post intervention and follow up 6 and 12 month

  • general (mental and physical) health state with SF-12

    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)

    scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up

Study Arms (2)

General Practice (GP) in Physio plus Deep water running

EXPERIMENTAL

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

General Practice in Physio

EXPERIMENTAL

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

Procedure: GP in Physio

Interventions

GP in PhysioPROCEDURE

manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment

General Practice in Physio
GP in Physio plus DWRPROCEDURE

GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold

General Practice (GP) in Physio plus Deep water running

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School Medicine University of Malaga

Málaga, Malaga, Spain

Location

Related Links

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antonio Cuesta-Vargas, PhD

    University of Malaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 27, 2009

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

April 27, 2009

Record last verified: 2009-04

Locations

ES(1)