Trial Outcomes & Findings for Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain (NCT NCT00803413)

Results Overview

Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

119 participants

Primary outcome timeframe

6 months

Results posted on

2008-12-05

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Back School	Supervised Walking	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.
Overall Period STARTED	28	32	29	30
Overall Period COMPLETED	28	32	29	30
Overall Period NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Back School n=28 Participants	Supervised Walking n=32 Participants	Backschool and Supervised Walking n=29 Participants 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 n=30 Participants 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 n=119 Participants Total of all reporting groups
Age Categorical <=18 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age Categorical Between 18 and 65 years	28 participants n=5 Participants	29 participants n=7 Participants	32 participants n=5 Participants	30 participants n=4 Participants	119 participants n=21 Participants
Age Categorical >=65 years	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Age Continuous	44.8 years STANDARD_DEVIATION 7.3 • n=5 Participants	47.2 years STANDARD_DEVIATION 7.1 • n=7 Participants	46.5 years STANDARD_DEVIATION 7.5 • n=5 Participants	46.8 years STANDARD_DEVIATION 7.2 • n=4 Participants	46.6 years STANDARD_DEVIATION 7.4 • n=21 Participants
Gender Female	28 participants n=5 Participants	29 participants n=7 Participants	32 participants n=5 Participants	30 participants n=4 Participants	119 participants n=21 Participants
Gender Male	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Region of Enrollment Brazil	28 participants n=5 Participants	29 participants n=7 Participants	32 participants n=5 Participants	30 participants n=4 Participants	119 participants n=21 Participants

PRIMARY outcome

Timeframe: 6 months

Patients were asked to indicate their perception about their LBP intensity with a cross on a line without marks, ranging from 1 (very light pain) through 10 (very strong pain)

Outcome measures

Outcome measures
Measure	Back School n=28 Participants	Supervised Walking n=32 Participants	Backschool and Supervised Walking n=29 Participants 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 n=30 Participants 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.
Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)	4.5 milimeters Standard Deviation 3.3	4.2 milimeters Standard Deviation 3.0	5.4 milimeters Standard Deviation 2.7	3.9 milimeters Standard Deviation 2.8

SECONDARY outcome

Timeframe: 6 months

Patients in up-right position with joined feet and stretched out arms were asked to bend the spine as much as possible without bending the knees; the least achieved distance between the 3rd fingertip and the floor was measured in centimeters with a proper rule.

Outcome measures

Outcome measures
Measure	Back School n=28 Participants	Supervised Walking n=32 Participants	Backschool and Supervised Walking n=29 Participants 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 n=30 Participants 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.
Spine Flexibility (3rd Fingertip to Floor - 3FF).	20.8 centimeters Standard Deviation 8.4	20.3 centimeters Standard Deviation 8.1	20.4 centimeters Standard Deviation 8.4	17.1 centimeters Standard Deviation 13.0

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mario Fereira Junior

Hospital das Clínicas - São Paulo University School of Medicine

Phone: 55 11 3069-7691

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place