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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2019-08-15

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.

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Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Physical Activity Intervention

Intervention Type OTHER

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

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.

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

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

Interventions

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Physical Activity Intervention

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

Intervention Type OTHER

Control group

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No