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

History of Changes

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

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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
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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

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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

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1. Primary:

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

Show Outcome Measure 1

2. Secondary:

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

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

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
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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

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