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
Results First Received: November 7, 2008  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Chronic Low Back Pain
Interventions: Behavioral: Back School Intervention
Behavioral: Supervised Walking Intervention
Behavioral: Back School and Walking
Behavioral: Control Group

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between August 2002 and March 2004, 351 women that attended 4 community centers located in the city of São Paulo, Brazil, responding to invitations by folders and voice announcements, filled a form with basic questions about physical activity and low back pain (LBP). After a clinical evaluation, 119 patients fulfilled the study criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Back School No text entered.
Supervised Walking No text entered.
Backschool and Supervised Walking Once a week for 5 consecitive weeks participants attended 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.
Control Group Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.

Participant Flow:   Overall Period
    Back School     Supervised Walking     Backschool and Supervised Walking     Control Group  
STARTED     28     32     29     30  
COMPLETED     28     32     29     30  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Back School No text entered.
Supervised Walking No text entered.
Backschool and Supervised Walking Once a week for 5 consecitive weeks participants attended 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.
Control Group Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
Total Total of all reporting groups

Baseline Measures
    Back School     Supervised Walking     Backschool and Supervised Walking     Control Group     Total  
Number of Participants  
[units: participants]
  28     32     29     30     119  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     28     29     32     30     119  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  44.8  ± 7.3     47.2  ± 7.1     46.5  ± 7.5     46.8  ± 7.2     46.6  ± 7.4  
Gender  
[units: participants]
         
Female     28     29     32     30     119  
Male     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
Brazil     28     29     32     30     119  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)   [ Time Frame: 6 months ]

2.  Secondary:   Spine Flexibility (3rd Fingertip to Floor – 3FF).   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mario Fereira Junior
Organization: Hospital das Clínicas - São Paulo University School of Medicine
phone: 55 11 3069-7691
e-mail: mariofj@uol.com.br


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