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

N/AUnknownNCT03200509

Universidade Estadual Paulista Júlio de Mesquita Filho160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Low Back Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Physical activity levels - Counts per minute

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)

Pain intensity

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

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

Disability

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

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

Secondary Outcomes

Physical activity levels - Counts per minute

Counts per minute will be measured with the Actigraph GT3X (ActiGraph, LLC, Pensacola, FL, USA).

Time frame: 6 and 12-month assessment after randomisation

Pain intensity

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

Time frame: 6 and 12-month assessment after randomisation

Disability

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

Time frame: 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).