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

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00803413
• Other study ID #: BSSW2002
• Status: Completed
• Phase: N/A
• First received: November 7, 2008
• Last updated: December 4, 2008
• Start date: August 2002
• Est. completion date: March 2004

Study information

• Verified date: December 2008
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: March 2004
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Behavioral:
• Back School Intervention
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)
• Supervised Walking Intervention
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.
• Back School and 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
• Control Group
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.

Locations

Country	Name	City	State
Brazil	Center for Health Promotion - Hospital das Clínicas - FMUSP	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of Low Back Pain (LBP) Self-Estimated by Visual Analogical Scale (VAS)		6 months	No
Secondary	Spine Flexibility (3rd Fingertip to Floor - 3FF).		6 months	No