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

Not Applicable

• Conditions: Low Back Pain
• Interventions: Other: Physical Activity Intervention; Other: Control group

• Registration Number: NCT03200509
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-23
• Study First Posted: 2017-06-27
• Study Start: 2017-08-31
• Primary Completion: 2019-01-21
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-30
• Last Update Posted: 2019-05-02
• Study Completion: 2019-08-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity Intervention	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.
Control group	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.

Primary Outcome Measures

Name	Time	Method
Physical activity levels - Counts per minute	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	Post-intervention (i.e. 3 months after randomisation)	Numerical Rating Scale for Pain assessment (NRS) (0-10)
Disability	Post-intervention (i.e. 3 months after randomisation)	Roland Morris Disability Questionnaire (RMDQ) (0-24)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sao Paulo State University; 🇧🇷 Presidente Prudente, Sao Paulo, Brazil