Orientation Booklet for Low Back Pain
Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain
1 other identifier
interventional
44
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable low-back-pain
Started May 2008
Typical duration for not_applicable low-back-pain
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
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 13, 2011
CompletedFirst Posted
Study publicly available on registry
September 26, 2011
CompletedSeptember 26, 2011
January 1, 2008
1.8 years
September 13, 2011
September 23, 2011
Conditions
Keywords
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
OTHERG1 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
Interventions
once a day, during 15 minutes, for 12 weeks
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rioko K Sakata, MD, PhD
Universidade Federal de São Paulo
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