Clinical trial NCT03376724: Functional Exercises for Chronic Low Back Pain
Official title: Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Low Back Pain
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Non-specific low back pain is a common condition. Exercise is effective treatment for chronic low back pain. We hypothesized the functional exercise group will present pain reduction and functional improvement.

The purpose of this study is investigated the effectiveness of an functional exercise program for people with nonspecific chronic low back pain. Patients will be randomly divided into 2 groups: control group (minimal intervention - mini back school and analgesic) and group will receive a functional exercise protocol associated with minimal intervention.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 50 years
* Low back pain for more than 3 months
* Low back pain with numeric pain scale between 3 - 8 cm
* Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

* Inflammatory/rheumatological diseases, tumor, infection or vertebral fracture;
* Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Previous spinal surgery;
* Previous spinal infiltration for pain relief in the last 3 months;
* Several scoliosis;
* Litigation;
* Pregnancy;
* Fibromyalgia;
* People who had changed physical activity or undergone physical therapy in the previous 3 months;
* Presence of any contraindication to exercise;
* Planned travel in the next 12 weeks;
* Geographic inaccessibility.

Primary outcomes:
measure: Low back of pain intensity measured with Numeric Pain Rating Scale
timeFrame: Baseline, 6, 12 and 24 weeks
Secondary outcomes:
measure: Disability associated to low back pain measured with Oswestry Disability Index
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Disability associated to low back pain measured with Roland Morris Disability
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Fear of movement measured with Fear-Avoidance Beliefs Questionnaire
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Quality of life measured with Short form-36 questionnaire
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Function measured with the 6-minute walk test
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Function measured with the timed to up and go test
timeFrame: Baseline, 6, 12 and 24 weeks
measure: Patient's global impression of recovery measured with a likert scale
timeFrame: 6, 12 and 24 weeks after baseline
measure: Analgesic consumption
timeFrame: 6, 12 and 24 weeks after baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Emilia Moreira
Study officials:
References: