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Completed

NCT Number: NCT00803413

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

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

Completed

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Key information

Conditions

Chronic Low Back Pain Behavior Motor Activity

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Center for Health Promotion - Hospital das Clínicas - FMUSP

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Back School Intervention

Behavioral

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)

Other names: BS

Supervised Walking Intervention

Behavioral

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.

Other names: W

Back School and Walking

Behavioral

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

Other names: BS+W

Control Group

Behavioral

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.

Other names: CG

Primary outcomes

  1. Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)

    Time frame: 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)

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effect of Back School and Supervised Walking in Sedentary Women With Chronic Low Back Pain: a Randomized Controlled Trial.

Important dates

Study start
2002
Primary completion
2003
Study completion
2004
First posted
Dec 5, 2008
Registry last updated
Dec 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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