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Orientation Booklet for Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiotherapy exercise
Sponsored by
Federal University of São Paulo
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, exercise, booklet

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    physiotherapy orientated

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    September 13, 2011
    Last Updated
    September 23, 2011
    Sponsor
    Federal University of São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01440491
    Brief Title
    Orientation Booklet for Low Back Pain
    Official Title
    Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2008 (undefined)
    Primary Completion Date
    March 2010 (Actual)
    Study Completion Date
    September 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Federal University of São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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 .
    Detailed Description
    After approval by the Ethics Committee and signing a consent form, a prospective, randomized trial was performed in 44 patients with chronic nonspecific low back pain (lasting longer than 3 months), pain intensity greater than 3 by visual analogue scale and age > 18 years. Patients with renal and gastrointestinal disease, simultaneously submitted to another type of physical therapy, cognitive impairment, and pregnant women were excluded. All patients received an exercise booklet which consisted of stretching and strengthening of muscles. G1 patients were orientated by the physiotherapist during the performance of exercises once a week, using the booklet, and the patients in G2 (n=22) received the booklet to self perform the exercises without orientation of the physiotherapist. Everyone should perform the exercises once a day at home. Pain intensity by VAS, and quality of life by SF-36 were measured before the start of treatment (T0), after 6 (T6) and 12 (T12) weeks. Side effects were recorded. Acetaminophen (up to 4 g / day) could be used as necessary. The sample size was provided by SAS 8.0, SPSS 15.0 program. To detect difference in pain intensity of 3 between the groups by VAS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 16. The program used for statistical analysis was SAS 8.0, SPSS 15.0. The tests used were Student's T to compare age of patients, chi-square to compare gender and analgesic complementation, and Mann Whitney test for pain intensity and quality of life.

    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, exercise, booklet

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    44 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    physiotherapy orientated
    Arm Type
    Other
    Arm Description
    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
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy exercise
    Other Intervention Name(s)
    Exercise therapy
    Intervention Description
    once a day, during 15 minutes, for 12 weeks
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Pain intensity was measured by VAS, and quality of life by SF-36
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: chronic nonspecific low back pain (lasting longer than 3 months), pain intensity greater than 3 by visual analogue scale and age > 18 years Exclusion Criteria: Patients with renal and gastrointestinal disease, simultaneously submitted to another type of physical therapy, cognitive impairment, and pregnant women were excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rioko K Sakata, MD, PhD
    Organizational Affiliation
    Universidade Federal de São Paulo
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Orientation Booklet for Low Back Pain

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