NCT01440491

Brief Summary

The aim of this study was to evaluate the effect of exercises performed under monitoring of the physiotherapist and self performed at home by reading the booklet of exercise orientation for patients with nonspecific low back pain. A prospective and randomized trial was performed in 44 patients. G1 patients received a physiotherapist orientation, and G2 patients received the booklet of exercise to self perform the exercises. Pain intensity by Visual Analogue Scale (VAS), and quality of life by SF-36 were measured before. Results: Pain intensity was lower in G1 than in G2 after 6 and 12 weeks. Quality of life was better in G1. The exercises under orientations of the physiotherapist promoted best effect than self performed exercises .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started May 2008

Typical duration for not_applicable low-back-pain

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 13, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 26, 2011

Completed
Last Updated

September 26, 2011

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

September 13, 2011

Last Update Submit

September 23, 2011

Conditions

Keywords

low back painexercisebooklet

Outcome Measures

Primary Outcomes (1)

  • Pain

    Pain intensity was measured by VAS, and quality of life by SF-36

    12 weeks

Study Arms (1)

physiotherapy orientated

OTHER

G1 patients were orientated by the physiotherapist during the performance of physiotherapy exercises, using the booklet G2 received the booklet to self perform the physiotherapy exercises

Other: Physiotherapy exercise

Interventions

once a day, during 15 minutes, for 12 weeks

Also known as: Exercise therapy
physiotherapy orientated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic nonspecific low back pain (lasting longer than 3 months),
  • pain intensity greater than 3 by visual analogue scale and age \> 18 years

You may not qualify if:

  • Patients with renal and gastrointestinal disease,
  • simultaneously submitted to another type of physical therapy,
  • cognitive impairment, and
  • pregnant women were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Rioko K Sakata, MD, PhD

    Universidade Federal de São Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pain Clinic Director

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 26, 2011

Study Start

May 1, 2008

Primary Completion

March 1, 2010

Study Completion

September 1, 2010

Last Updated

September 26, 2011

Record last verified: 2008-01