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

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.

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.

Study Design

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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

U.S. FDA Resources

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures :

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 :

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.
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.
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

Eligibility Criteria

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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.

Contacts and Locations

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

More Information

Publications:

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.

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.

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:S192-300.

Hartvigsen J, Morsø 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.

Brown CA. The beliefs of people with chronic pain in relation to 'important' treatment components. Eur J Pain. 2004 Aug;8(4):325-33.

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.

Kuukkanen T, Mälkiä 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.

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. Review.

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. Erratum in: Am J Respir Crit Care Med. 2016 May 15;193(10):1185.

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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

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