Back to resultsEffect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Back School Intervention
Supervised Walking Intervention
Back School and Walking
Control Group
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Low Back Pain focused on measuring Chronic low back pain, Back School, Walking, Physical activity
Eligibility 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
Sites / Locations
- Center for Health Promotion - Hospital das Clínicas - FMUSP
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
Back School
Supervised Walking
Back School and Walking
Control Group
Arm Description
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)
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
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
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.
Outcomes
Primary Outcome Measures
Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)
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)
Secondary Outcome Measures
Spine Flexibility (3rd Fingertip to Floor - 3FF).
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.
Full Information
NCT ID
NCT00803413
First Posted
November 7, 2008
Last Updated
December 4, 2008
Sponsor
University of Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT00803413
Brief Title
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
Official Title
Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
August 2002 (undefined)
Primary Completion Date
June 2003 (Actual)
Study Completion Date
March 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Do Back School and/or supervised walking improve reported pain and spine flexibility in sedentary women with chronic low back pain (LBP)?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
Chronic low back pain, Back School, Walking, Physical activity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
119 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Back School
Arm Type
Other
Arm Description
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)
Arm Title
Supervised Walking
Arm Type
Other
Arm Description
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
Arm Title
Back School and Walking
Arm Type
Other
Arm Description
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
Arm Title
Control Group
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Back School Intervention
Other Intervention Name(s)
BS
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Supervised Walking Intervention
Other Intervention Name(s)
W
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Back School and Walking
Other Intervention Name(s)
BS+W
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Control Group
Other Intervention Name(s)
CG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)
Description
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)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Spine Flexibility (3rd Fingertip to Floor - 3FF).
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Ferreira Junior, PhD
Organizational Affiliation
Hospital das Clínicas - São Paulo University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Promotion - Hospital das Clínicas - FMUSP
City
São Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
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Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain
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