Low Back PainPAyBACKNCT03200509

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

A study testing Physical Activity Intervention in people with Low Back Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Low Back Pain
What is being tested?: Physical Activity Intervention
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 160 participants
Where: 1 siteBrazil
Study dates: 31 Aug 2017to 15 Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Sao Paulo State University
Presidente Prudente, São Paulo, 19060900

Other trials in Brazil

About this study

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

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.

Conditions: Low Back Pain
Being tested: Physical Activity Intervention, Control group
Keywords: nonspecific low back pain, chronic pain
Medical subject headings: Low Back Pain, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Physical Activity InterventionOther
Participants will receive a group exercise program, health coaching sessions and an activity monitor.
Control groupOther
Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.

Study groups in NCT03200509
Study group	Role	What they receive
Physical Activity Intervention	Experimental	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. Receives: Other: Physical Activity Intervention
Control group	Sham comparator	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. Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 Aug 201715 Aug 2019

First posted27 Jun 2017
Study start31 Aug 2017
Primary completion21 Jan 2019
Study completion15 Aug 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03200509
Sponsor's protocol ID: 1718
Acronym: PAyBACK
Status last verified: Apr 2019
First submitted: 22 Jun 2017
Last updated: 2 May 2019
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 29334992
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.
PubMed 35536245

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
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Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03200509
Acronym / sponsor ID: PAyBACK / 1718
Conditions: Low Back Pain
Keywords: nonspecific low back pain, chronic pain
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 160 participants (actual)
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
Collaborators: University of Sydney
Study start: 31 Aug 2017 (actual)
Primary completion: 21 Jan 2019 (actual)
Study completion: 15 Aug 2019 (estimated)
First posted: 27 Jun 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Physical Activity Intervention	Experimental	Other: Physical Activity InterventionThe 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.
Control group	Sham comparator	Other: Control groupThe 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.

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Physical Activity InterventionParticipants will receive a group exercise program, health coaching sessions and an activity monitor.	Other	Physical Activity Intervention
Control groupParticipants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.	Other	Control group

Primary outcome

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).
Pain intensity
Time frame: Post-intervention (i.e. 3 months after randomisation)
Numerical Rating Scale for Pain assessment (NRS) (0-10)
Disability
Time frame: Post-intervention (i.e. 3 months after randomisation)
Roland Morris Disability Questionnaire (RMDQ) (0-24)

15 secondary outcomes

Physical activity levels - Counts per minute
Time frame: 6 and 12-month assessment after randomisation
Pain intensity
Time frame: 6 and 12-month assessment after randomisation
Disability
Time frame: 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
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
Physical activity levels - steps
Time frame: 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
Self-reported physical activity level
Time frame: 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
Depression
Time frame: 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
Pain self-efficacy
Time frame: 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
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
Global Perceived Effect Scale (GPES)
Time frame: Post-intervention (i.e. 3 months after randomisation)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
Background: PubMed 29334992Oliveira 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.
Derived from this study: PubMed 35536245Oliveira 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.
Physical Activity Interventions for Increasing Objectively Measured Physical Activity Levels in Patients With Chronic Musculoskeletal Pain: A Systematic ReviewLink provided by the sponsor.
Unlocking the potential of physical activity for back healthLink provided by the sponsor.

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention in people with Low Back Pain, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity levels - Counts per minute (time frame: Post-intervention (i.e. 3 months after randomisation)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03200509, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.