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

U

Universidade Estadual Paulista Júlio de Mesquita Filho

Status

Unknown

Conditions

Low Back Pain

Treatments

Other: Physical Activity Intervention
Other: Control group

Study type

Interventional

Funder types

Other

Identifiers

NCT03200509
1718

Details and patient eligibility

About

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.

Enrollment

160 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

160 participants in 2 patient groups

Physical Activity Intervention
Experimental group
Description:
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.
Treatment:
Other: Physical Activity Intervention
Control group
Sham Comparator group
Description:
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.
Treatment:
Other: Control group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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