NCT03200509

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

August 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2019

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

June 22, 2017

Last Update Submit

April 30, 2019

Conditions

Low Back Pain

Keywords

nonspecific low back painchronic pain

Outcome Measures

Primary Outcomes (3)

  • Physical activity levels - Counts per minute

    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

    Numerical Rating Scale for Pain assessment (NRS) (0-10)

    Post-intervention (i.e. 3 months after randomisation)

  • Disability

    Roland Morris Disability Questionnaire (RMDQ) (0-24)

    Post-intervention (i.e. 3 months after randomisation)

Secondary Outcomes (15)

  • Physical activity levels - Counts per minute

    6 and 12-month assessment after randomisation

  • Pain intensity

    6 and 12-month assessment after randomisation

  • Disability

    6 and 12-month assessment after randomisation

  • Physical activity levels - light physical activity

    Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up

  • Physical activity levels - moderate-to-vigorous physical activity

    Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up

  • +10 more secondary outcomes

Study Arms (2)

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.

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.

Other: Control group

Interventions

Physical Activity InterventionOTHER

Participants will receive a group exercise program, health coaching sessions and an activity monitor.

Physical Activity Intervention
Control groupOTHER

Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sao Paulo State University

Presidente Prudente, São Paulo, 19060900, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 29334992BACKGROUND

  • 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.

    PMID: 35536245DERIVED

Related Links

MeSH Terms

Conditions

Low Back PainChronic Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 27, 2017

Study Start

August 31, 2017

Primary Completion

January 21, 2019

Study Completion

August 15, 2019

Last Updated

May 2, 2019

Record last verified: 2019-04

Locations

BR(1)