NCT00803413

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2002

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2008

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 5, 2008

Completed
Same day until next milestone

Results Posted

Study results publicly available

December 5, 2008

Completed
Last Updated

December 5, 2008

Status Verified

December 1, 2008

Enrollment Period

10 months

First QC Date

November 7, 2008

Results QC Date

November 7, 2008

Last Update Submit

December 4, 2008

Conditions

Keywords

Chronic low back painBack SchoolWalkingPhysical activity

Outcome Measures

Primary Outcomes (1)

  • 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)

    6 months

Secondary Outcomes (1)

  • Spine Flexibility (3rd Fingertip to Floor - 3FF).

    6 months

Study Arms (4)

Back School

OTHER

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)

Behavioral: Back School Intervention

Supervised Walking

OTHER

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

Behavioral: Supervised Walking Intervention

Back School and Walking

OTHER

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

Behavioral: Back School and Walking

Control Group

OTHER

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.

Behavioral: Control Group

Interventions

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)

Also known as: BS
Back School

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.

Also known as: W
Supervised 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

Also known as: BS+W
Back School and Walking
Control GroupBEHAVIORAL

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.

Also known as: CG
Control Group

Eligibility Criteria

Age30 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Any known organic cause of LBP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Health Promotion - Hospital das Clínicas - FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

MeSH Terms

Conditions

Motor Activity

Interventions

WalkingControl Groups

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

LocomotionMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaExerciseMotor ActivityEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Results Point of Contact

Title
Mario Fereira Junior
Organization
Hospital das Clínicas - São Paulo University School of Medicine

Study Officials

  • Mario Ferreira Junior, PhD

    Hospital das Clínicas - São Paulo University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2008

First Posted

December 5, 2008

Study Start

August 1, 2002

Primary Completion

June 1, 2003

Study Completion

March 1, 2004

Last Updated

December 5, 2008

Results First Posted

December 5, 2008

Record last verified: 2008-12

Locations