Clinical trial NCT01719276: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2012-11-01
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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;

Primary outcomes:
measure: Pain
timeFrame: 6 weeks
measure: Functional Disability
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 6 weeks
measure: Global Perceived Effect
timeFrame: 6 weeks
measure: Return to work
timeFrame: 6 weeks
measure: Habitual physical activity
timeFrame: 6 weeks
measure: Physical Capacity
timeFrame: 6 weeks
measure: Kinesiophobia
timeFrame: Tampa Scale of Kinesophobia (TSK)
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Medicine School of the University Of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Amelia P Marques, PHD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Mauricio O Magalhaes, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.