Orientation Booklet for Low Back Pain
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2011 | ||||
| Last Updated Date | September 23, 2011 | ||||
| Start Date ICMJE | May 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Pain [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Pain intensity was measured by VAS, and quality of life by SF-36 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01440491 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Orientation Booklet for Low Back Pain | ||||
| Official Title ICMJE | Effect of Orientation Through a Booklet of Exercise in Patients With Low Back Pain | ||||
| 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 . |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Low Back Pain | ||||
| Intervention ICMJE | Other: Physiotherapy exercise
once a day, during 15 minutes, for 12 weeks
Other Name: Exercise therapy |
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| Study Arm (s) | physiotherapy orientated
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: Other: Physiotherapy exercise |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 44 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01440491 | ||||
| Other Study ID Numbers ICMJE | CEP1871/07 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Rioko Kimiko Sakata, Federal University of São Paulo | ||||
| Study Sponsor ICMJE | Federal University of São Paulo | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Federal University of São Paulo | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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