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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • São 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Estadual Paulista Júlio de Mesquita Filho

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 22, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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