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

Primary Purpose

Low Back Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise protocol
Manual of exercises
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, physical exercise and quality of life

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Exercise protocol

    Manual of exercises

    Arm Description

    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

    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.

    Outcomes

    Primary Outcome Measures

    Visual Analogue Pain Scale to asses Low Back Pain
    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

    Short-Form Survey (SF-36) to evaluate life quality
    change from baseline in life quality after intervention -Survey with 36 items that measure 8 variable.
    Six minutes walk-test - Functional capacity
    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.
    sit and reach test - flexibility
    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

    Full Information

    First Posted
    February 17, 2016
    Last Updated
    March 3, 2016
    Sponsor
    Hospital de Clinicas de Porto Alegre
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02703402
    Brief Title
    Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back
    Official Title
    Effects of an Exercise Program Under Supervision and Unsupervised in the Treatment of Low Back Pain: a Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2016 (undefined)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hospital de Clinicas de Porto Alegre

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Low Back Pain
    Keywords
    low back pain, physical exercise and quality of life

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    122 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise protocol
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Manual of exercises
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Exercise protocol
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Manual of exercises
    Intervention Description
    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 Measure Information:
    Title
    Visual Analogue Pain Scale to asses Low Back Pain
    Description
    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).
    Time Frame
    24 months
    Secondary Outcome Measure Information:
    Title
    Short-Form Survey (SF-36) to evaluate life quality
    Description
    change from baseline in life quality after intervention -Survey with 36 items that measure 8 variable.
    Time Frame
    24 months
    Title
    Six minutes walk-test - Functional capacity
    Description
    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.
    Time Frame
    24 months
    Title
    sit and reach test - flexibility
    Description
    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
    Time Frame
    24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luciana Aparecida B. Piccoli, MD
    Phone
    0555133597634
    Email
    lucianapiccolipersonal@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rosane M. Nery, PhD
    Phone
    0555133597634
    Email
    rosane.nery@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Antonio C. dos Santos, PhD
    Organizational Affiliation
    Hospital de Clínicas de Porto Alegre
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19473905
    Citation
    Ben Salah Frih Z, Fendri Y, Jellad A, Boudoukhane S, Rejeb N. Efficacy and treatment compliance of a home-based rehabilitation programme for chronic low back pain: a randomized, controlled study. Ann Phys Rehabil Med. 2009 Jul;52(6):485-96. doi: 10.1016/j.rehab.2009.04.002. Epub 2009 May 15. English, French.
    Results Reference
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    PubMed Identifier
    12381971
    Citation
    Descarreaux M, Normand MC, Laurencelle L, Dugas C. Evaluation of a specific home exercise program for low back pain. J Manipulative Physiol Ther. 2002 Oct;25(8):497-503. doi: 10.1067/mmt.2002.127078.
    Results Reference
    background
    PubMed Identifier
    16550448
    Citation
    Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.
    Results Reference
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    PubMed Identifier
    20146793
    Citation
    Hartvigsen J, Morso L, Bendix T, Manniche C. Supervised and non-supervised Nordic walking in the treatment of chronic low back pain: a single blind randomized clinical trial. BMC Musculoskelet Disord. 2010 Feb 10;11:30. doi: 10.1186/1471-2474-11-30.
    Results Reference
    background
    PubMed Identifier
    15207513
    Citation
    Brown CA. The beliefs of people with chronic pain in relation to 'important' treatment components. Eur J Pain. 2004 Aug;8(4):325-33. doi: 10.1016/j.ejpain.2003.10.005.
    Results Reference
    background
    PubMed Identifier
    20628332
    Citation
    Shirado O, Doi T, Akai M, Hoshino Y, Fujino K, Hayashi K, Marui E, Iwaya T; Japan Low back-pain Exercise Therapy Study; Investigators Japanese Orthopaedic Association; Japanese Society for Musculoskeletal Rehabilitation; Japanese Clinical Orthopaedic Association. Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study. Spine (Phila Pa 1976). 2010 Aug 1;35(17):E811-9. doi: 10.1097/BRS.0b013e3181d7a4d2.
    Results Reference
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    PubMed Identifier
    17849435
    Citation
    Kuukkanen T, Malkia E, Kautiainen H, Pohjolainen T. Effectiveness of a home exercise programme in low back pain: a randomized five-year follow-up study. Physiother Res Int. 2007 Dec;12(4):213-24. doi: 10.1002/pri.378.
    Results Reference
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    PubMed Identifier
    11427782
    Citation
    Vuori IM. Dose-response of physical activity and low back pain, osteoarthritis, and osteoporosis. Med Sci Sports Exerc. 2001 Jun;33(6 Suppl):S551-86; discussion 609-10. doi: 10.1097/00005768-200106001-00026.
    Results Reference
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    PubMed Identifier
    12091180
    Citation
    ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories. ATS statement: guidelines for the six-minute walk test. Am J Respir Crit Care Med. 2002 Jul 1;166(1):111-7. doi: 10.1164/ajrccm.166.1.at1102. No abstract available. Erratum In: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.
    Results Reference
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