NCT02703402

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
122

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable low-back-pain

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2016

Completed
13 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 9, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

February 17, 2016

Last Update Submit

March 3, 2016

Conditions

Low Back Pain

Keywords

low back painphysical exercise and quality of life

Outcome Measures

Primary Outcomes (1)

  • 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).

    24 months

Secondary Outcomes (3)

  • 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

Study Arms (2)

Exercise protocol

EXPERIMENTAL

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

Manual of exercises

EXPERIMENTAL

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

Interventions

Exercise protocolOTHER

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.

Exercise protocol
Manual of exercisesOTHER

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

Manual of exercises

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 19473905BACKGROUND

  • 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.

    PMID: 12381971BACKGROUND

  • 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.

    PMID: 16550448BACKGROUND

  • 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.

    PMID: 20146793BACKGROUND

  • 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.

    PMID: 15207513BACKGROUND

  • 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.

    PMID: 20628332BACKGROUND

  • 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.

    PMID: 17849435BACKGROUND

  • 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.

    PMID: 11427782BACKGROUND

  • 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.

    PMID: 12091180BACKGROUND

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Antonio C. dos Santos, PhD

    Hospital de ClĂ­nicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Aparecida B. Piccoli, MD

CONTACT

0555133597634lucianapiccolipersonal@gmail.com

Rosane M. Nery, PhD

CONTACT

0555133597634rosane.nery@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

March 9, 2016

Record last verified: 2016-03