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

Low Back Pain Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03200509
• Other study ID #: 1718
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: August 15, 2019

Study information

• Verified date: April 2019
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: August 15, 2019
• Est. primary completion date: January 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Physical Activity Intervention
Participants will receive a group exercise program, health coaching sessions and an activity monitor.
• Control group
Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.

Locations

Country	Name	City	State
Brazil	Sao Paulo State University	Presidente Prudente	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	University of Sydney

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

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

External Links

•   Physical Activity Interventions for Increasing Objectively Measured Physical Activity Levels in Patients With Chronic Musculoskeletal Pain: A Systematic Review
•   Unlocking the potential of physical activity for back health