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

Study Overview

• Status: Unknown
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Graded Activity; Other: Supervised Exercises

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%.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 01246903
    • Medicine School of the University Of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire	6 weeks
Functional Disability	Roland Morris Disability Questionnaire	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Short-Form Health Survey Questionnaire	6 weeks
Global Perceived Effect	Global Perceived Effect Scale	6 weeks
Return to work	Patients will be asked if returned their professional activities.	6 weeks
Habitual physical activity	The Baecke questionnaire on habitual physical activity	6 weeks
Physical Capacity	physical capacity tests (sit-to-stand and 50-foot walk)	6 weeks
Kinesiophobia	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.	Tampa Scale of Kinesophobia (TSK)

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Study Director: Amelia P Marques, PHD, University of Sao Paulo; Principal Investigator: Mauricio O Magalhaes, MSc, University of Sao Paulo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: October 26, 2012
• First Submitted That Met QC Criteria: October 31, 2012
• First Posted (ESTIMATE): November 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 16, 2014
• Last Update Submitted That Met QC Criteria: June 13, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: mauriciomag20