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

NCT01719276 | Unknown DMC

• 1 other identifier: mauriciomag20
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pain

  Pain Numerical Rating Scale (NRS) and McGill Pain Questionnaire

  6 weeks

• Functional Disability

  Roland Morris Disability Questionnaire

  6 weeks

Secondary Outcomes (6)

• Quality of life

  6 weeks

• Global Perceived Effect

  6 weeks

• Return to work

  6 weeks

• Habitual physical activity

  6 weeks

• Physical Capacity

  6 weeks

Study Arms (2)

Graded Activity

ACTIVE COMPARATOR

Exercise treadmill, Strengthening of the lower limbs and trunk

Other: Graded Activity; Other: Supervised Exercises

Supervised exercises

ACTIVE COMPARATOR

Stretching, Strengthening, Motor Control

Other: Graded Activity; Other: Supervised Exercises

Interventions

Graded Activity OTHER

The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.

Graded Activity; Supervised exercises

Supervised Exercises OTHER

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.

Graded Activity; Supervised exercises

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Medicine School of the University Of São Paulo

São Paulo, São Paulo, 01246903, Brazil

Location

Related Publications (1)

• 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.

  PMID: 23336703 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amelia P Marques, PHD

  University of Sao Paulo

  STUDY DIRECTOR

• Mauricio O Magalhaes, MSc

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mauricio Oliveira Magalhães

Study Record Dates

• First Submitted: October 26, 2012
• First Posted: November 1, 2012
• Study Start: February 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: December 1, 2015
• Last Updated: June 16, 2014

Record last verified: 2014-06

Locations

BR (1)