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Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back

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ClinicalTrials.gov Identifier: NCT02703402
Recruitment Status : Unknown
Verified March 2016 by Hospital de Clinicas de Porto Alegre.
Recruitment status was:  Not yet recruiting
First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Exercise protocol Other: Manual of exercises Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back Pain: a Randomized Clinical Trial
Study Start Date : March 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Exercise protocol
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
Other: Exercise protocol
Control group 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.

Experimental: Manual of exercises
Treatment Group: 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.
Other: Manual of exercises
Treatment group 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Short-Form Survey (SF-36) to evaluate life quality [ Time Frame: 24 months ]
    change from baseline in life quality after intervention -Survey with 36 items that measure 8 variable.

  2. Six minutes walk-test - Functional capacity [ Time Frame: 24 months ]
    Change from baseline in functional capacity ater intervention - measure the distance walked during 6 minutes. Performed in a corridor with a 30 meter distance with two cones in the extremities.

  3. sit and reach test - flexibility [ Time Frame: 24 months ]
    change from baseline in flexibility after intervention - individual in the sitting position with legs extended oriented move the marker on millimeter surface, held 3 times and considered the greatest value



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02703402


Contacts
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Contact: Luciana Aparecida B. Piccoli, MD 0555133597634 lucianapiccolipersonal@gmail.com
Contact: Rosane M. Nery, PhD 0555133597634 rosane.nery@gmail.com

Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Antonio C. dos Santos, PhD Hospital de Clínicas de Porto Alegre
Publications:

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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02703402    
Other Study ID Numbers: 15-0526
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: March 9, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
low back pain
physical exercise and quality of life
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations