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

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