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Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
This study has been completed.
Sponsored by: University of Sao Paulo
Information provided by: University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00803413
  Purpose

Do Back School and/or supervised walking improve reported pain and spine flexibility in sedentary women with chronic low back pain (LBP)?


Condition Intervention
Chronic Low Back Pain
Behavioral: Back School Intervention
Behavioral: Supervised Walking Intervention
Behavioral: Back School and Walking
Behavioral: Control Group

MedlinePlus related topics: Back Pain
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
Official Title: Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Spine Flexibility (3rd Fingertip to Floor - 3FF). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: August 2002
Study Completion Date: March 2004
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Back School
Participants received weekly sessions of 45 minutes including: 15-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, and spine preventive care; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening)
Behavioral: Back School Intervention
Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, and spine preventive care; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening)
Supervised Walking
Participants received weekly sessions of 45 minutes including: 15-minute lectures about basics of physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised walking in group
Behavioral: Supervised Walking Intervention
Patients were submitted once a week for 5 consecutive weeks to sessions of 45 minutes including: 15-minute lectures about basics of physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised walking in group.
Back School and Walking
Participants received weekly sessions of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group
Behavioral: Back School and Walking
Weekly sessions of 90 minutes including: 30-minute lectures about basics of spine's anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities
Control Group
Participants received weekly sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention; beside the 2-page folder content this group received no other information about LBP, BS or walking all along the follow-up.
Behavioral: Control Group
Weekly sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention.; beside the 2-page folder content this group received no other information about LBP, BS or walking all along the follow-up.

Detailed Description:

From August 2002 to March 2004, one hundred nineteen volunteers sedentary women with chronic LBP and age ranging from 32 to 60 years old, randomly allocated to four groups of participants assigned as Back School (BS; N=28), Supervised Walking (W; N=32), Back School and Supervised Walking (BS+W; N=29), and Control Group (CG; N=30) were submitted to interventions once a week for 5 consecutive weeks and followed for up to 6 months. The groups BS, W, and BS+W received LBP-targeted lectures and on-place practical sessions of each respective intervention. CG received print information about LBP and 5 different lectures unrelated to LBP.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age range 30 to 60 years old
  • LBP without any known organic cause for at least 3 months of duration
  • Less than 90 minutes per week of regular physical activity of any intensity

Exclusion Criteria:

  • Any known organic cause of LBP
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00803413

Locations
Brazil
Center for Health Promotion - Hospital das Clínicas - FMUSP
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Mario Ferreira Junior, PhD Hospital das Clínicas - São Paulo University School of Medicine
  More Information

Responsible Party: Hospital das Clínicas - São Paulo University School of Medicine ( Mario Ferreira Junior )
Study ID Numbers: BSSW2002
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: December 4, 2008
ClinicalTrials.gov Identifier: NCT00803413  
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Chronic low back pain
Back School
Walking
Physical activity

Study placed in the following topic categories:
Signs and Symptoms
Neurologic Manifestations
Low Back Pain
Pain
Back Pain

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009