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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Activity Intervention
Control group
Sponsored by
Universidade Estadual Paulista Júlio de Mesquita Filho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring nonspecific low back pain, chronic pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sao Paulo State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Physical Activity Intervention

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Physical activity levels - Counts per minute
Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).
Pain intensity
Numerical Rating Scale for Pain assessment (NRS) (0-10)
Disability
Roland Morris Disability Questionnaire (RMDQ) (0-24)

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2017
Last Updated
April 30, 2019
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
University of Sydney
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1. Study Identification

Unique Protocol Identification Number
NCT03200509
Brief Title
Efficacy of a Multimodal Physical Activity Intervention in Patients With Chronic Nonspecific Low Back Pain
Acronym
PAyBACK
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
January 21, 2019 (Actual)
Study Completion Date
August 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
University of Sydney

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
nonspecific low back pain, chronic pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sao Paulo State University
City
Presidente Prudente
State/Province
Sao Paulo
ZIP/Postal Code
19060900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29334992
Citation
Oliveira CB, Franco MR, Maher CG, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Christofaro DGD, Pinto RZ. The 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 (Physical Activity for Back Pain (PAyBACK) trial): study protocol for a randomised controlled trial. Trials. 2018 Jan 15;19(1):40. doi: 10.1186/s13063-017-2436-z.
Results Reference
background
PubMed Identifier
35536245
Citation
Oliveira CB, Christofaro DGD, Maher CG, Franco MR, Tiedemann A, Silva FG, Damato TM, Nicholas MK, Pinto RZ. Adding Physical Activity Coaching and an Activity Monitor Was No More Effective Than Adding an Attention Control Intervention to Group Exercise for Patients With Chronic Nonspecific Low Back Pain (PAyBACK Trial): A Randomized Trial. J Orthop Sports Phys Ther. 2022 May;52(5):287-299. doi: 10.2519/jospt.2022.10874.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/27111744
Description
Physical Activity Interventions for Increasing Objectively Measured Physical Activity Levels in Patients With Chronic Musculoskeletal Pain: A Systematic Review
URL
https://www.ncbi.nlm.nih.gov/pubmed/28202450
Description
Unlocking the potential of physical activity for back health

Learn more about this trial

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

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