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

NCT ID: NCT01719276

Last Updated: 2014-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-12-31

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%.

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Graded Activity

Exercise treadmill, Strengthening of the lower limbs and trunk

Group Type: ACTIVE_COMPARATOR

Graded Activity

Intervention Type: OTHER

The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.

Supervised Exercises

Intervention Type: OTHER

The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.

Supervised exercises

Stretching, Strengthening, Motor Control

Group Type: ACTIVE_COMPARATOR

Graded Activity

Intervention Type: OTHER

The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.

Supervised Exercises

Intervention Type: OTHER

The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.

Interventions

Graded Activity

The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.

Intervention Type: OTHER

Supervised Exercises

The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.

Intervention Type: OTHER

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Mauricio Oliveira Magalhães

Mauricio Oliveira Magalhães

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amelia P Marques, PHD

Role: STUDY_DIRECTOR

University of Sao Paulo

Mauricio O Magalhaes, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Medicine School of the University Of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Magalhaes MO, Franca FJ, Burke TN, Ramos LA, de Moura Campos Carvalho e Silva AP, Almeida GP, Yuan SL, Marques AP. Efficacy of graded activity versus supervised exercises in patients with chronic non-specific low back pain: protocol of a randomised controlled trial. BMC Musculoskelet Disord. 2013 Jan 21;14:36. doi: 10.1186/1471-2474-14-36.

Reference Type: DERIVED

PMID: 23336703 (View on PubMed)

Other Identifiers

mauriciomag20

Identifier Type: -

Identifier Source: org_study_id