Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain (PAyBACK)

April 30, 2019 updated by: Crystian Bitencourt Soares de Oliveira, Universidade Estadual Paulista Júlio de Mesquita Filho

Efficacy of a Multimodal Physical Activity Intervention With Supervised Exercises, Health Coaching and an Activity Monitor on Physical Activity Levels of Patients With Chronic Nonspecific Low Back Pain: PAyBACK Trial

Physical activity plays an important role in the management of chronic low back pain (LBP). Engaging in an active lifestyle is associated with a better prognosis. Nevertheless, there is evidence to suggest that patients with chronic LBP are less likely to meet recommended physical activity levels. Furthermore, while exercise therapy has been endorsed by recent clinical practice guidelines, evidence from systematic reviews suggests that its effect on pain and disability are at best moderate and not sustained over time. A limitation of current exercises programs for chronic LBP is that these programs are not designed to change patient's behaviour toward an active lifestyle. Therefore, the objective of this study is to investigate the short and long-term efficacy of a multimodal intervention consisting of supervised exercises, health coaching and use of an activity monitor (i.e. Fitbit Flex) compared to supervised exercises plus sham coaching and a sham activity monitor on physical activity levels, pain intensity and disability in patients with chronic nonspecific LBP.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Sao Paulo
      • Presidente Prudente, Sao Paulo, Brazil, 19060900
        • Sao Paulo State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic nonspecific LBP, defined as pain and discomfort localised below the costal margin and above the inferior gluteal folds, with or without leg pain and of at least 3 months' duration

Exclusion Criteria:

  • Serious spine pathology (e.g. tumors, fractures, and inflammatory diseases)
  • Nerve root compromise (i.e. at least 2 of the following signs: weakness, reflex change, or sensation loss associated with the same spinal nerve)
  • Spinal surgery
  • Pregnancy
  • Illiteracy
  • Insufficient understanding of the Portuguese language
  • Cardiorespiratory Diseases fibromyalgia or any other musculoskeletal condition that may affect activity and movement will be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical Activity Intervention
The participants from both groups will receive a group exercise program, including a combination of general, stabilisation, strengthening and resistance exercises. In addition, the intervention group will receive health coaching sessions and an activity monitor.
Other: Physical Activity Intervention
Participants will receive a group exercise program, health coaching sessions and an activity monitor.
Sham Comparator: Control group
The participants from both groups will receive a group exercise program, including a combination of general, stabilisation, strengthening and resistance exercises. The participants allocated to the control group will receive sham health coaching and a sham activity monitor, in addition to the exercise program.
Other: Control group
Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity levels - Counts per minute
Time Frame: Post-intervention (i.e. 3 months after randomisation)
Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Post-intervention (i.e. 3 months after randomisation)
Pain intensity
Time Frame: Post-intervention (i.e. 3 months after randomisation)
Numerical Rating Scale for Pain assessment (NRS) (0-10)
Post-intervention (i.e. 3 months after randomisation)
Disability
Time Frame: Post-intervention (i.e. 3 months after randomisation)
Roland Morris Disability Questionnaire (RMDQ) (0-24)
Post-intervention (i.e. 3 months after randomisation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical activity levels - Counts per minute
Time Frame: 6 and 12-month assessment after randomisation
Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
6 and 12-month assessment after randomisation
Pain intensity
Time Frame: 6 and 12-month assessment after randomisation
Numerical Rating Scale for Pain assessment (NRS) (0-10)
6 and 12-month assessment after randomisation
Disability
Time Frame: 6 and 12-month assessment after randomisation
Roland Morris Disability Questionnaire (RMDQ) (0-24)
6 and 12-month assessment after randomisation
Physical activity levels - light physical activity
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Time spent in light physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Physical activity levels - moderate-to-vigorous physical activity
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Time spent in moderate-to-vigorous physical activity will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Physical activity levels - steps
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Number of steps will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Sedentary behavior
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Time spent in sedentary behavior will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Self-reported physical activity level
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Baecke Habitual Physical Activity Questionnaire
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Self-reported sedentary behavior
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Questions about the time spent in sedentary behavior
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Depression
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
The Center for Epidemiological Studies - Depression (CES-D) scale (0-60)
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
General quality of life
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
EuroQol visual analogue scale (EQ-VAS) (0-100)
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Pain self-efficacy
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Pain Self-Efficacy Questionnaire (PSEQ) (0-60)
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Weight-related outcomes - Body mass index
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Body mass index
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Weight-related outcomes - Waist-to-hip circumference
Time Frame: Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Waist-to-hip circumference
Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up
Global Perceived Effect Scale (GPES)
Time Frame: Post-intervention (i.e. 3 months after randomisation)
Perception of recovery
Post-intervention (i.e. 3 months after randomisation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

University of Sydney

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2017

Primary Completion (Actual)

January 21, 2019

Study Completion (Anticipated)

August 15, 2019

Study Registration Dates

First Submitted

June 22, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 27, 2017

Study Record Updates

Last Update Posted (Actual)

May 2, 2019

Last Update Submitted That Met QC Criteria

April 30, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1718

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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