Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Graded Activity; Other: Supervised Exercises

• Registration Number: NCT01719276
• Lead Sponsor: University of Sao Paulo

Brief Summary

The purpose of this study is to compare the efficacy of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain

Detailed Description

Objective: To contrast the efficacy of of graded activity program and supervised exercise on pain, functional disability, quality of life, global perceived effect, return to work, physical activity, physical capacity and strength of the lower limbs in patients with chronic non-specific low back pain

Design: Sixty-six will be randomized into two groups namely: Graded Activity program (GA)(n = 33) and supervised exercise (SE) (n = 33). The primary clinical outcomes will be pain, assessed with the numerical pain scale and McGill Pain Questionnaire, and disability assessed with Roland Morris Disability Questionnaire. Secondary outcomes will be measured with Global Perceived Effect, quality of life, return to work, physical activity, functional capacity and strength of the lower limbs. The program lasts for 6 weeks, and sessions happen twice a week, with duration of one hour each. Evaluations will be performed before(baseline), after (6weeks) and with a follow-up 3 and 6 months after treatment. Data will be collected by a blinded examiner who also had made the allocation of patients to groups. Significance level is established at 5%.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-26
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Study Start: 2013-02
• Primary Completion: 2014-01
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-13
• Last Update Posted: 2014-06-16
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• Patients with non-specific chronic low back pain for at least three months, age between 18 and 65 year of both genders and with a minimum pain intensity score of three in the 11-point Pain Numerical Rating Scale (ranging from 0 to 10 points).

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Exclusion Criteria

• Known or suspected serious spinal pathology (fractures, tumors, inflammatory or infective diseases of the spine);

  • Nerve root compromise;
  • Comorbid health conditions that would prevent active participation in the exercise programs;
  • Pregnancy;
  • Cardio Respiratory illnesses;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Graded Activity	Graded Activity	Exercise treadmill, Strengthening of the lower limbs and trunk
Supervised exercises	Graded Activity	Stretching, Strengthening, Motor Control
Graded Activity	Supervised Exercises	Exercise treadmill, Strengthening of the lower limbs and trunk
Supervised exercises	Supervised Exercises	Stretching, Strengthening, Motor Control

Primary Outcome Measures

Name	Time	Method
Functional Disability	6 weeks	Roland Morris Disability Questionnaire
Pain	6 weeks	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

Secondary Outcome Measures

Name	Time	Method
Return to work	6 weeks	Patients will be asked if returned their professional activities.
Quality of life	6 weeks	Short-Form Health Survey Questionnaire
Habitual physical activity	6 weeks	The Baecke questionnaire on habitual physical activity
Physical Capacity	6 weeks	physical capacity tests (sit-to-stand and 50-foot walk)
Global Perceived Effect	6 weeks	Global Perceived Effect Scale
Kinesiophobia	Tampa Scale of Kinesophobia (TSK)	self-applied questionnaire consisting of 17 items, which was developed to measure the fear of movement due to cLBP. Each question has 4 response options (strongly disagree, disagree, agree, and strongly agree) with scores respectively ranging from 1 to 4 points.

Trial Locations

Locations (1)

Medicine School of the University Of São Paulo; 🇧🇷 São Paulo, Brazil