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Clinical Trials/NCT02703402
NCT02703402
Unknown
N/A

Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back Pain: a Randomized Clinical Trial

Hospital de Clinicas de Porto Alegre0 sites122 target enrollmentMarch 2016
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Hospital de Clinicas de Porto Alegre
Enrollment
122
Primary Endpoint
Visual Analogue Pain Scale to asses Low Back Pain
Last Updated
10 years ago

Overview

Brief Summary

ABSTRACT: Low back pain is one of the most frequent causes of incapacity. The prevalence of this syndrome is 60-85% for the survival of the individuals. Among the most promising strategies of low back pain intervention, is the physical activity that is usually associated with a long list of health benefits.

Detailed Description

Purpose: evaluate the efficacy of a protocol of exercises to low back pain rehabilitation under supervision of physiatry service and rehabilitation in the Hospital de Clínicas de Porto Alegre compared with same protocol performed at home in regards to pain. Methods: Randomized clinical trial with a sample of 122 subjects of the community of both sex, with ages between 30 to 55, with low back pain complain. These subjects will accomplish during 12 weeks protocol of exercises from "Exercises to low back pain" Physiatry and Rehabilitation service from HCPA, randomized in two groups: group 1 will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA. Group 2 will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises.

Registry
clinicaltrials.gov
Start Date
March 2016
End Date
March 2018
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ages between 30 and 55
  • Pain should be without radiation to lower body
  • Pain with more than 12 weeks of evolution.
  • Visual Analog Scale of Pain (VAS) should present a pattern above 3 (moderate).

Exclusion Criteria

  • Patients with Exclusion Criteria: will be excluded those patients that present musculoskeletal impairment in lower body,
  • After surgery and anesthetic block.
  • individuals affected with comorbidities
  • Patients with rheumatic diseases, recent fractures, tumors, pregnant women, smokers and general practitioners of physical activity.
  • Subjects who are unable to attend the hospital twice a week.

Outcomes

Primary Outcomes

Visual Analogue Pain Scale to asses Low Back Pain

Time Frame: 24 months

Visual Analogue Pain Scale (EVA) - change from baseline pain after the intervention - evaluates the intensity of pain using a ruler divided into eleven equal parts, with a classification from 0 (painless) and 10 (maximum pain).

Secondary Outcomes

  • Short-Form Survey (SF-36) to evaluate life quality(24 months)
  • Six minutes walk-test - Functional capacity(24 months)
  • sit and reach test - flexibility(24 months)

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