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

Low Back Pain Clinical Trial

Official title:

EFFECT OF COGNITIVE-BEHAVIORAL THERAPY AND EXERCISE VERSUS SUPERVISED EXERCISE PROGRAM IN PATIENTS WITH CHRONIC PAIN LUMBAR NO SPECIFIC: RANDOMIZED CONTROLLED TRIAL

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01719276
• Other study ID #: mauriciomag20
• Status: Active, not recruiting
• Phase: N/A
• First received: October 26, 2012
• Last updated: June 13, 2014
• Start date: February 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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%.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Brazil	Medicine School of the University Of São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire	6 weeks	Yes
Primary	Functional Disability	Roland Morris Disability Questionnaire	6 weeks	Yes
Secondary	Quality of life	Short-Form Health Survey Questionnaire	6 weeks	Yes
Secondary	Global Perceived Effect	Global Perceived Effect Scale	6 weeks	Yes
Secondary	Return to work	Patients will be asked if returned their professional activities.	6 weeks	Yes
Secondary	Habitual physical activity	The Baecke questionnaire on habitual physical activity	6 weeks	Yes
Secondary	Physical Capacity	physical capacity tests (sit-to-stand and 50-foot walk)	6 weeks	Yes
Secondary	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)	Yes