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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Physical Activity Intervention
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity Intervention<br>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<br>* Participants will receive a group exercise program, health coaching sessions and an activity monitor.<br>|
| Sham Comparator: Control group<br>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<br>* Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pain intensity | Numerical Rating Scale for Pain assessment (NRS) (0-10) | 6 and 12-month assessment after randomisation | 
| Disability | Roland Morris Disability Questionnaire (RMDQ) (0-24) | 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). | 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). | 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). | 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). | 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 | 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 | 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) | 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) | 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) | 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 | 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 | Post-intervention (i.e. 3 months after randomisation) and at 6 and 12-month follow-up | 
| Global Perceived Effect Scale (GPES) | Perception of recovery | Post-intervention (i.e. 3 months after randomisation) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nonspecific low back pain, chronic pain