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

October 26, 2012
June 13, 2014
February 2013
January 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01719276 on ClinicalTrials.gov Archive Site
  • 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.
  • 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)
  • Muscle Strength of Lower limbs [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Handheld dynamometer to assess the strength of the knee flexors and extensors.
Not Provided
Not Provided
 
Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain
EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL

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

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%.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Low Back Pain
  • 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: Graded Activity
    Exercise treadmill, Strengthening of the lower limbs and trunk
    Interventions:
    • Other: Graded Activity
    • Other: Supervised Exercises
  • Active Comparator: Supervised exercises
    Stretching, Strengthening, Motor Control
    Interventions:
    • Other: Graded Activity
    • Other: Supervised Exercises
Magalhaes MO, França 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
66
December 2015
January 2014   (final data collection date for primary outcome measure)

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;
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01719276
mauriciomag20
Yes
Mauricio Oliveira Magalhães, University of Sao Paulo
University of Sao Paulo
Not Provided
Study Director: Amelia P Marques, PHD University of São Paulo
Principal Investigator: Mauricio O Magalhaes, MSc University of São Paulo
University of Sao Paulo
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP