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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Mauricio Oliveira Magalhães, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01719276
First received: October 26, 2012
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention
Low Back Pain
Other: Graded Activity
Other: Supervised Exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

  • Functional Disability [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Roland Morris Disability Questionnaire


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Short-Form Health Survey Questionnaire

  • Global Perceived Effect [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Global Perceived Effect Scale

  • Return to work [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Patients will be asked if returned their professional activities.

  • Habitual physical activity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    The Baecke questionnaire on habitual physical activity

  • Physical Capacity [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    physical capacity tests (sit-to-stand and 50-foot walk)

  • Kinesiophobia [ Time Frame: Tampa Scale of Kinesophobia (TSK) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 66
Study Start Date: February 2013
Estimated Study Completion Date: December 2015
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Graded Activity
Exercise treadmill, Strengthening of the lower limbs and trunk
Other: Graded Activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
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.
Active Comparator: Supervised exercises
Stretching, Strengthening, Motor Control
Other: Graded Activity
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
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.

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%.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01719276

Locations
Brazil
Medicine School of the University Of São Paulo
São Paulo, Brazil, 01246903
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Director: Amelia P Marques, PHD University of São Paulo
Principal Investigator: Mauricio O Magalhaes, MSc University of São Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mauricio Oliveira Magalhães, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01719276     History of Changes
Other Study ID Numbers: mauriciomag20
Study First Received: October 26, 2012
Last Updated: June 13, 2014
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014