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
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, exercise, booklet
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
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
NCT ID
NCT01440491
First Posted
September 13, 2011
Last Updated
September 23, 2011
Sponsor
Federal University of São Paulo
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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