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Clinical Trials/NCT03376724
NCT03376724
Unknown
Not Applicable

Effectiveness of the Functional Exercises in Young Adults Chronic Low Back Pain: a Randomized Controlled Trial

Federal University of São Paulo1 site in 1 country84 target enrollmentNovember 10, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Low Back Pain
Sponsor
Federal University of São Paulo
Enrollment
84
Locations
1
Primary Endpoint
Low back of pain intensity measured with Numeric Pain Rating Scale
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 10, 2017
End Date
November 10, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo
Responsible Party
Principal Investigator
Principal Investigator

Emilia Moreira, PT

Pfysiotherapist, MsC

Federal University of São Paulo

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;

Outcomes

Primary Outcomes

Low back of pain intensity measured with Numeric Pain Rating Scale

Time Frame: Baseline, 6, 12 and 24 weeks

It will be measured by the Brazilian version of the Numeric Pain Rating Scale (NPRS) 11 points. The NPRS goes from 0 to 10, where 0 is "no pain" and 10 is "the worst pain imaginable." Participants will be asked to answer about their pain levels based on the last seven days. Change in pain score or an improvement of 2 levels or more is accepted as clinically relevant.

Secondary Outcomes

  • Fear of movement measured with Fear-Avoidance Beliefs Questionnaire(Baseline, 6, 12 and 24 weeks)
  • Function measured with the 6-minute walk test(Baseline, 6, 12 and 24 weeks)
  • Function measured with the timed to up and go test(Baseline, 6, 12 and 24 weeks)
  • Patient's global impression of recovery measured with a likert scale(6, 12 and 24 weeks after baseline)
  • Analgesic consumption(6, 12 and 24 weeks after baseline)
  • Disability associated to low back pain measured with Oswestry Disability Index(Baseline, 6, 12 and 24 weeks)
  • Quality of life measured with Short form-36 questionnaire(Baseline, 6, 12 and 24 weeks)
  • Disability associated to low back pain measured with Roland Morris Disability(Baseline, 6, 12 and 24 weeks)

Study Sites (1)

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