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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Graded Activity
Supervised Exercises
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Medicine School of the University Of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Graded Activity

Supervised exercises

Arm Description

Exercise treadmill, Strengthening of the lower limbs and trunk

Stretching, Strengthening, Motor Control

Outcomes

Primary Outcome Measures

Pain
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
Functional Disability
Roland Morris Disability Questionnaire

Secondary Outcome Measures

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

Full Information

First Posted
October 26, 2012
Last Updated
June 13, 2014
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01719276
Brief Title
Graded Activity Versus Supervised Exercises in Patients With Chronic Non-specific Low Back Pain
Official Title
EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Graded Activity
Arm Type
Active Comparator
Arm Description
Exercise treadmill, Strengthening of the lower limbs and trunk
Arm Title
Supervised exercises
Arm Type
Active Comparator
Arm Description
Stretching, Strengthening, Motor Control
Intervention Type
Other
Intervention Name(s)
Graded Activity
Intervention Description
The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
Intervention Type
Other
Intervention Name(s)
Supervised Exercises
Intervention Description
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 Outcome Measure Information:
Title
Pain
Description
Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire
Time Frame
6 weeks
Title
Functional Disability
Description
Roland Morris Disability Questionnaire
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Quality of life
Description
Short-Form Health Survey Questionnaire
Time Frame
6 weeks
Title
Global Perceived Effect
Description
Global Perceived Effect Scale
Time Frame
6 weeks
Title
Return to work
Description
Patients will be asked if returned their professional activities.
Time Frame
6 weeks
Title
Habitual physical activity
Description
The Baecke questionnaire on habitual physical activity
Time Frame
6 weeks
Title
Physical Capacity
Description
physical capacity tests (sit-to-stand and 50-foot walk)
Time Frame
6 weeks
Title
Kinesiophobia
Description
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.
Time Frame
Tampa Scale of Kinesophobia (TSK)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amelia P Marques, PHD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mauricio O Magalhaes, MSc
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medicine School of the University Of São Paulo
City
São Paulo
ZIP/Postal Code
01246903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
23336703
Citation
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.
Results Reference
derived

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

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