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Completed

NCT Number: NCT00888524

Plus Deep Water Running on Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School Medicine University of Malaga

Málaga, Malaga, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GP in Physio

Procedure

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

GP in Physio plus DWR

Procedure

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

Primary outcomes

  1. pain in VAS

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Acronym: +DWR

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2009
Registry last updated
Apr 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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