Overview

This trial is active, not recruiting.

Condition low back pain
Treatments graded activity, supervised exercises
Sponsor University of Sao Paulo
Start date February 2013
End date January 2014
Trial size 66 participants
Trial identifier NCT01719276, mauriciomag20

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Exercise treadmill, Strengthening of the lower limbs and trunk
graded activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
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.
(Active Comparator)
Stretching, Strengthening, Motor Control
graded activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
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.

Primary Outcomes

Measure
Pain
time frame: 6 weeks
Functional Disability
time frame: 6 weeks

Secondary Outcomes

Measure
Quality of life
time frame: 6 weeks
Global Perceived Effect
time frame: 6 weeks
Return to work
time frame: 6 weeks
Habitual physical activity
time frame: 6 weeks
Physical Capacity
time frame: 6 weeks
Kinesiophobia
time frame: Tampa Scale of Kinesophobia (TSK)

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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;

Additional Information

Official title EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL
Principal investigator Mauricio O Magalhaes, MSc
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%.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by University of Sao Paulo.