Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

November 7, 2008
December 4, 2008
August 2002
June 2003   (final data collection date for primary outcome measure)
Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00803413 on ClinicalTrials.gov Archive Site
Spine Flexibility (3rd Fingertip to Floor - 3FF). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Chronic Low Back Pain
  • 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
  • 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
  • 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
  • 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
  • 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)
    Intervention: Behavioral: Back School Intervention
  • 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
    Intervention: Behavioral: Supervised Walking Intervention
  • 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
    Intervention: Behavioral: Back School and Walking
  • 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.
    Intervention: Behavioral: Control Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
119
March 2004
June 2003   (final data collection date for primary outcome measure)

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
Female
30 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00803413
BSSW2002
No
Mario Ferreira Junior, Hospital das Clínicas - São Paulo University School of Medicine
University of Sao Paulo
Not Provided
Principal Investigator: Mario Ferreira Junior, PhD Hospital das Clínicas - São Paulo University School of Medicine
University of Sao Paulo
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP