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Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00803413
First received: November 7, 2008
Last updated: December 4, 2008
Last verified: December 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.

Resource links provided by NLM:


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)
Other Name: BS
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.
Other Name: W
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
Other Name: BS+W
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.
Other Name: CG

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Mario Ferreira Junior, Hospital das Clínicas - São Paulo University School of Medicine
ClinicalTrials.gov Identifier: NCT00803413     History of Changes
Other Study ID Numbers: BSSW2002
Study First Received: November 7, 2008
Results First Received: November 7, 2008
Last Updated: December 4, 2008
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

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014