Plus Deep Water Running on Low Back Pain

Low Back Pain Clinical Trial

— +DWR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888524
• Other study ID #: 857 IAC 0630041300
• Secondary ID: 857 IAC 06300413
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: April 24, 2009
• Start date: January 2006
• Est. completion date: September 2007

Study information

• Verified date: April 2009
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Procedure:
• GP in Physio
manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment
• GP in Physio plus DWR
GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold

Locations

Country	Name	City	State
Spain	School Medicine University of Malaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain in VAS		scale 0 -100, pre and post intervention and follow up 6 and 12 month	Yes
Secondary	disability RMQ		scale 0-24, pre and post intervention and follow up 6 and 12 month	Yes
Secondary	general (mental and physical) health state with SF-12		scale 0 -100, pre and post intervention and follow up 6 and 12 month	Yes
Secondary	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	Yes

External Links

•   Food and Drugs Administration
•   Research And Development of Spain
•   University of Malaga