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

University of Sao Paulo

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Graded Activity; Other: Supervised Exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT01719276

mauriciomag20

Details and patient eligibility

About

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

Full 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%.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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).

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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66 participants in 2 patient groups

Graded Activity

Active Comparator group

Description:

Exercise treadmill, Strengthening of the lower limbs and trunk

Treatment:

Other: Graded Activity

Other: Supervised Exercises

Supervised exercises

Active Comparator group

Description:

Stretching, Strengthening, Motor Control

Treatment:

Other: Graded Activity

Other: Supervised Exercises